97年度醫療器材採認標準資料單

DOH-000479
ABC.
CEI/IEC 61326-2-6:2005
Electrical equipment for measurement, control and

laboratory use - EMC requirements - Part 2-6: Particular
requirements - In vitro diagnostic (IVD) medical equipment
2005-12-15
International Electrotechnical Commission
Horizontal
In vitro diagnostic (IVD) medical equipment
Specifies minimum requirements for immunity and

emissions regarding electromagnetic compatibility for in
vitro diagnostic medical equipment, taking into account the
particularities and specific aspects of this electrical
equipment and their electromagnetic environment.
Vertical
DOH-000480
ABC.
ISO 22870:2006
Point-of-care testing (POCT) -- Requirements for quality

and competence
2006-02-03
International Organization for Standardization (ISO)
Horizontal
Clinical laboratory testing and in vitro diagnostic test

systems
ISO 22870:2006 gives specific requirements

applicable to point-of-care testing and is intended to
be used in conjunction with ISO 15189. The
requirements of ISO 22870:2006 apply when POCT is
carried out in hospital, clinic and by a healthcare
organization providing ambulatory care. It can be
applied to transcutaneous measurements, the analysis
of expired air, and in vivo monitoring of physiological
parameters.
Vertical
Patient self-testing in a home or community setting is

excluded, but elements of ISO 22870:2006 can be
applicable
DOH-000481
ABC.
POCT1-A2
Point-of-Care Connectivity; Approved Standard- Second

Edition
2006-07-28
Clinical and Laboratory Standards Institute
Horizontal
Lab Information Systems, Auto Analysis
This standard provides the framework for engineers to

design devices, work stations, and interfaces that allow
multiple types and brands of point-of-care devices to
communicate bidirectionally with access points, data
managers, and laboratory information systems from a
variety of vendors.
Vertical
DOH-000482
ABC.
POCT2-P
Implementation Guide of POCT1 for Healthcare Providers;

Proposed Guideline
2007-03-08
Horizontal
This document identifies and describes the particular

features that a POCT1-compliant device should ideally
have. These features are divided into obligatory and
desirable categories. The guideline thus gives the healthcare
provider or end user a practical basis for establishing a list
of features or questions to be addressed by the vendor of a
compliant device.
Vertical
DOH-000483
ABC.
POCT4-A2
Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved

Guideline - Second Edition
2006-08-29
Horizontal
In vitro diagnostic (IVD) devices outside the clinical

laboratory
This document provides guidance to users of in vitro

diagnostic (IVD) devices outside the clinical laboratory, to
ensure reliable results comparable to those obtained within
the clinical laboratory.
Vertical
DOH-000484
ABC.
CNS 15035:2006
95/10/31
Horizontal
()

()
Vertical
DOH-000485
ABC.
AST3-A
Wellness Testing Using IVD Devices; Approved Guideline
1999-02
Horizontal
Wellness Testing Using IVD Devices
Wellness Testing Using IVD Devices; Approved Guideline

(NCCLS document AST3-A) provides useful information
to directors of wellness testing services to assist them in
implementing a quality program. The guideline addresses
preanalytical and postanalytical considerations and safety
and training issues related to wellness testing using IVD
devices. While the guideline does not specify which tests
should be included in a wellness program,it includes
recommendations for providing accurate and adequate
information as well as referring participants to clinicians for
subsequent follow-up, depending on the results obtained
from common wellness tests.
Vertical
DOH-000486
ABC.
AST4-A2
Glucose Monitoring in Settings Without Laboratory

Support; Approved GuidelineSecond Edition
2005-05
Horizontal
Glucose test system
Clinical and Laboratory Standards Institute document

AST4-A2, Glucose Monitoring in Settings Without
Laboratory Support; Approved GuidelineSecond Edition
was developed for personnel monitoring glucose levels at
sites other than a hospital laboratory. In a question and
answer format, the document provides recommendations
related to administrative structure, operator authorization,
test system selection, quality assurance, and test procedure.
Also included are samples of a written evaluation and
quality control logs. The second half of the guideline can be
used to create an on-site procedure manual.
Vertical
DOH-000487
ABC.
AUTO1-A
Laboratory Automation: Specimen Container/Specimen

Carrier; Approved Standard
2000-12-20
Horizontal
ALL CONTAINERS, SPECIMEN TRANSPORT
This document provides standards for the design and

manufacture of specimen containers and carriers used for
collecting and processing liquid samples, such as blood and
urine, for clinical testing in laboratory automation systems.
Vertical
DOH-000488
ABC.
AUTO2-A2
Laboratory Automation: Bar Codes for Specimen Container

Identification; Approved Standard Second Edition
2006-01-05
Horizontal
Auto Analyses, Reagent Containers
This document provides specifications for use of linear bar

codes on specimen container tubes in the clinical laboratory
and for use on laboratory automation systems.
Vertical
DOH-000489
ABC.
AUTO5-A
Laboratory Automation: Electromechanical Interfaces;

Approved Standard
2001-03-20
Horizontal
This document provides standards for the development of

an electromechanical interface between instruments and
specimen processing and handling devices used in
automated laboratory testing procedures.
Vertical
DOH-000490
AUTO7-A
Laboratory Automation: Data Content for Specimen

Identification; Approved Standard
2004-06-20
AUTO7-A
Horizontal
This document provides specifications for the content of

linear bar codes on specimen container tubes in the clinical
laboratory and for use on laboratory automation systems.
Vertical
DOH-000491
ABC.
AUTO8-P
Protocols to Validate Laboratory Information Systems;

Proposed Guideline
2006-12-19
Horizontal
Laboratory Information Systems
This document provides guidance for developing a protocol

for validation of the laboratory information system (LIS), as
well as protocols for assessing the dependability of the LIS
when storing, retrieving, and transmitting data.
Vertical
DOH-000492
ABC.
AUTO9-P
Remote Access to Clinical Laboratory Diagnostic Devices

via the Internet; Proposed Standard
2006-12-19
Horizontal
Laboratory information system
This document provides guidance for developing a protocol

for validation of the laboratory information system (LIS), as
well as protocols for assessing the dependability of the LIS
when storing, retrieving, and transmitting data.
Vertical
DOH-000493
ABC.
C37-A
Preparation and Validation of Commutable Frozen Human

Serum Pools as Secondary Reference Materials for
Cholesterol Measurement Procedures; Approved Guideline
1999-11-01
Horizontal
IN VITRO DIAGNOSTIC DEVICES FOR THE

MEASUREMENT OF TOTAL CHOLESTEROL, HDL
CHOLESTEROL AND LDL CHOLESTEROL IN VITRO
DIAGNOSTIC CALIBRATOR MATERIALS
This guideline details procedures for the manufacture and
evaluation of human serum pools for cholesterol
measurement.
Vertical
DOH-000494
ABC.
C40-A
Analytical Procedures for the Determination of Lead in

Blood and Urine; Approved Guideline
2001-06-01
Horizontal
A device intended to measure lead, a heavy metal, in blood

and urine.
This document provides guidelines for the measurement of

lead in blood and urine, including specimen collection,
measurement by graphite furnace atomic absorption
spectrometry and anodic stripping voltammetry, quality
assurance, and quality control.
Vertical
DOH-000495
ABC.
EP6-A
Evaluation of the Linearity of Quantitative Measurement

Procedures: A Statistical Approach; Approved Guideline
2003-04-01
Horizontal
IVD medical devices.
This document provides guidance for characterizing the

linearity of a method during a method evaluation; for
checking linearity as part of routine quality assurance; and
for determining and stating a manufacturer's claim for linear
range.
Vertical
DOH-000496
ABC.
EP17-A
Protocols for Determination of Limits of Detection and

Limits of Quantitation; Approved Guideline
2004-10-20
Horizontal
This document provides guidance for determining the lower

limit of detection of clinical laboratory methods, for
verifying claimed limits, and for the proper use and
interpretation of the limits.
Vertical
DOH-000497
ABC.
EP21-A
Estimation of Total Analytical Error for Clinical Laboratory

Methods; Approved Guideline
2003-04-20
Horizontal
This document provides manufacturers and end users with a

means to estimate total analytical error for an assay. A data
collection protocol and an analysis method which can be
used to judge the clinical acceptability of new methods
using patient specimens are included. These tools can also
monitor an assays total analytical error by using quality
control samples.
Vertical
DOH-000498
ABC.
GP10-A
Assessment of the Clinical Accuracy of Laboratory Tests

Using Receiver Operating Characteristic (ROC) Plots;
Approved Guideline
1995-12-01
Horizontal
All quantitative IVD assays
This document describes the design of a study to evaluate

clinical accuracy of laboratory tests and contains procedures
for preparing ROC curves; glossary of terms; and
information on computer software programs.
Vertical
DOH-000499
ABC.
M6-A
Protocols for Evaluating Dehydrated MuellerHinton Agar;

Approved Standard
2003-10-20
Horizontal
ALL SUSCEPTIBILITY DISCS FOR STANDARD

METHOD
This document provides guidance for the development and

use of quantitative molecular methods, such as nucleic acid
probes and nucleic acid amplification techniques of the
target sequences specific to partiular microgranisms. It also
presents recommendations for quality assurance,
proficiency testing, and interpreation of results.
Vertical
DOH-000500
ABC.
M7-A7
Methods for Dilution Antimicrobial Susceptibility Tests for

Bacteria That Grow Aerobically; Approved Standard
Seventh Edition
2006-01-03
Horizontal
ANTIMICROBIAL SUSCEPTIBILITY SYSTEMS
This document addresses reference methods for the

determination of minimal inhibitory concentrations (MICs)
of aerobic bacteria by broth macrodilution, broth
microdilution, and agar dilution.
Vertical
DOH-000501
ABC.
M21-A
Methodology for the Serum Bactericidal Test; Approved

Guideline
1999-09-01
Horizontal
Culture medium for antimicrobial susceptibility tests.
This guideline describes a direct method of antimicrobial

susceptibility testing using patient's serum to measure the
activity of serum against bacterial pathogen isolated from
the patient.
Vertical
DOH-000502
ABC.
M22-A3
Quality Control for Commercially Prepared

Microbiological Culture Media; Approved StandardThird
Edition
2004-06-20
Horizontal
IVDs
This standard contains quality assurance procedures for

manufacturers and users of prepared, ready-to-use
microbiological culture media.
Vertical
DOH-000503
ABC.
M23-A2
Development of In Vitro Susceptibility Testing Criteria and

Quality Control Parameters; Approved GuidelineSecond
Edition
2001-05-01
Horizontal
IVDs
This document addresses the required and recommended

data needed for the selection of appropriate interpretive
standards and quality control guidelines for antimicrobial
agents.
Vertical
DOH-000504
ABC.
M24-A
Susceptibility Testing of Mycobacteria, Nocardiae, and

Other Aerobic Actinomycetes; Approved Standard
2003-04-01
Horizontal
Antimicrobial susceptibility systems
This standard provides protocols and related quality control

parameters and interpretive criteria for the susceptibility
testing of mycobacteria, Nocardiae spp. and other aerobic
actinomycetes.
Vertical
DOH-000505
ABC.
M26-A
Methods for Determining Bactericidal Activity of

Antimicrobial Agents; Approved Guideline
1999-09-01
Horizontal
Products related to antimicrobial susceptibility test.
This guideline contains procedures for determining the

lethal activity of antimicrobial agents.
Vertical
DOH-000506
ABC.
M31-S1
Performance Standards for Antimicrobial Disk and Dilution

Susceptibility Tests for Bacteria Isolated from Animals;
Informational Supplement
2004-05-01
Horizontal
The supplemental information presented in this document is intended

for use with the antimicrobial disk and dilution testing procedures
published in the NCCLS approved standard M31-A2Performance
Standards for Antimicrobial Disk and Dilution Susceptibility Tests
for Bacteria Isolated from Animals; Approved StandardSecond
Edition.
Vertical
If the susceptibility of a bacterial pathogen to antimicrobial agents

cannot be predicted based on the identity of the organism alone, in
vitro antimicrobial susceptibility testing of the organism isolated from
the disease processes in animals is indicated. Susceptibility testing is
particularly necessary in those situations where the etiologic agent
belongs to a bacterial species for which resistance to commonly used
antimicrobial agents has been documented, or could arise.
The tabular information in this document presents the most current
information for drug selection, interpretation, and quality control. As
more veterinary-specific information has become available since the
publication of M31-A2, the need to quickly disseminate that new
information by means of a supplement was determined to be in the
best interests of the user community. It is anticipated that as more
veterinary-specific information becomes available, additional
supplements will be published.
DOH-000507
ABC.
M31-A2
Performance Standards for Antimicrobial Disk and Dilution

Susceptibility Tests for Bacteria Isolated from Animals;
Approved StandardSecond Edition
2002-05-01
Horizontal
This document provides the currently recommended

techniques for antimicrobial agent disk and dilution
susceptibility testing, criteria for quality control testing, and
interpretive criteria for veterinary use.
Vertical
DOH-000508
ABC.
M32-P
Evaluation of Lots of Dehydrated Mueller-Hinton Broth for

Antimicrobial Susceptibility Testing; Proposed Guideline
2001-12-01
Horizontal
Culture media for antimicrobial susceptibility test (Mueller

Hinton agar/broth).
This document describes methods for evaluation of

production lots of Mueller Hinton broth by manufacturers
of the dehydrated product. Performance of production lots
is determined by testing defined organism/antimicrobial
combinations. The results of testing must conform to
defined quality control limit ranges for each combination of
antimicrobial and ATCC quality control strain. Guidelines
are provided for ranges of specific ion contents (cations and
anions) that will provide results within the defined quality
control limit ranges.
Vertical
DOH-000509
ABC.
M39-P
Analysis and Presentation of Cumulative Antimicrobial

Susceptibility Test Data; Approved Guideline
2002-05
Horizontal
This document describes methods for recording and

analysis of antimicrobial susceptibility test data, consisting
of cumulative and ongoing summaries of susceptibility
patterns of clinically significant microorganisms.
Vertical
DOH-000510
ABC.
M45-P
Methods for Antimicrobial Dilution and Disk Susceptibility

Testing of Infrequently Isolated or Fastidious Bacteria;
Proposed Guideline
2005-10
Horizontal
If the susceptibility of a bacterial pathogen to antimicrobial agents

cannot be predicted based on the identity of the organism alone, in
vitro antimicrobial susceptibility testing of the organism isolated from
the disease processes is indicated. Susceptibility testing is particularly
necessary in those situations where the etiologic agent belongs to a
bacterial species for which resistance to commonly used antimicrobial
agents has been documented, or could arise.
Vertical
A variety of laboratory techniques can be used to measure the in vitro

susceptibility of bacteria to antimicrobial agents. This document
describes the standard microdilution and agar disk diffusion methods.
It also includes a series of procedures designed to standardize test
performance. The performance, applications, and limitations of the
current CLSI/NCCLS-recommended methods are described.
The tabular information in this document presents the most current
information for drug selection, interpretation, and quality control for
the infrequently isolated or fastidious bacterial pathogens included in
this guideline. As more information becomes available, changes will
be incorporated into future revisions of this document.
DOH-000511
ABC.
MM13-A
Collection, Transport, Preparation, and Storage of

Specimens for Molecular Methods; Approved Guideline
2006-01-06
Horizontal
Products related to the collection, transport, preparation,

and storage of specimens for molecular methods.
This standard addresses topics that relate to proper and safe

biological specimen collection and nucleic acid isolation
and purification. These topics include methods of
collection, recommended storage and transport conditions,
and available nucleic acid purification technologies for each
specimen/nucleic acid type.
Vertical
DOH-000512
3.
ISO 11140-1:2005
Sterilization of health care products -- Chemical indicators

-- Part 1: General requirements
2005-07-15
Horizontal
Chemical indicators intended for use by health care

facilities
ISO 11140-1:2005 specifies general requirements and test

methods for indicators that show exposure to sterilization
processes by means of physical and/or chemical change of
substances, and which are used to monitor the attainment of
one or more of the variables required for a sterilization
process. They are not dependent for their action on the
presence or absence of a living organism.
Vertical
The requirements and test methods of ISO 11140-1:2005

apply to all indicators specified in subsequent parts of ISO
11140, unless the requirement is modified or added to by a
subsequent part, in which case the requirement of that
particular part will apply.
DOH-000513
2.
ISO 10993-3:2003
Biological evaluation of medical devices -- Part 3: Tests for

genotoxicity, carcinogenicity and reproductive toxicity
2003-10-15
Horizontal
1, rue de Varembe, Case postale 56, CH-1211 Geneva 20,

Switzerland
-All permanent surface devices that contact mucosal

membrane and breached or compromised surfaces
-Permanent external communicating devices that contact
blood path indirectly
-Prolonged and permanent external communicating devices
that contact tissue/bone/dentin
-All external communicating devices that contact the
circulating blood
-All prolonged and permanent contact implant devices
Vertical
DOH-000514
2.
ISO 10993-4:2002/Amd 1:2006
Biological evaluation of medical devices -- Part 4: Selection

of tests for interactions with blood
2006-07-15
Horizontal
Medical devices that contact the circulating blood
Detailed requirements for testing cannot be specified

because of the limitations in knowledge and precision of
tests for interactions of devices with blood. Further, this
part of ISO 10993 describes biological evaluation in general
terms and may not necessarily provide sufficient guidance
for test methods for a specific device.
Vertical
The selection and design of test methods should take into

consideration device design, materials, clinical utility, usage
environment and risk benefit. This level of specificity can
only be covered in vertical standards.
DOH-000515
2.
ISO 10993-6:2007
Biological evaluation of medical devices -- Part 6: Tests for

local effects after implantation
2007-04-04
Horizontal
All medical devices
ISO 10993-6:2007 specifies test methods for the assessment of

the local effects after implantation of biomaterials intended for
use in medical devices.
Vertical
ISO 10993-6:2007 applies to materials that are:

1. solid and non-biodegradable;
2. degradable and/or resorbable;
3. non-solid, such as porous materials, liquids, pastes and
particulates.
ISO 10993-6:2007 may also be applied to medical devices that
are intended to be used topically in clinical indications where
the surface or lining may have been breached, in order to
evaluate local tissue responses.
This part of ISO 10993 does not deal with systemic toxicity,
carcinogenicity, teratogenicity or mutagenicity. However, the
long-term implantation studies intended for evaluation of local
biological effects may provide insight into some of these
properties. Systemic toxicity studies conducted by implantation
may satisfy the requirements of ISO 10993-6:2007.
DOH-000516
2.
ISO 10993-10:2002/Amd 1:2006
Biological evaluation of medical devices -- Part 10: Tests

for irritation and delayed-type hypersensitivity
2006-07-15
Horizontal
All medical devices
This part of ISO 10993 describes the procedure for the

assessment of medical devices and their constituent
materials with regard to their potential to produce
irritation and delayed-type hypersensitivity.
Vertical
This part of ISO 10993 includes pretest considerations,

details of the test procedures, and key factors for the
interpretation of the results.
DOH-000517
2.
ISO 10993-11:2006
Biological evaluation of medical devices -- Part 11: Tests

for systemic toxicity
2006-08-15
Horizontal
Surface devices contacting mucosal membranes and

breached or compromised surfaces
All external communicating devices
All implant devices
ISO 10993-11:2006 specifies requirements and gives
guidance on procedures to be followed in the evaluation of
the potential for medical device materials to cause adverse
systemic reactions.
Vertical
DOH-000518
3.
ISO 11138-1:2006
Sterilization of health care products -- Biological indicators

-- Part 1: General requirements
2006-07-01
Horizontal
Biological indicators intended for use by health care

facilities for monitoring sterilization processes
ISO 11138-1:2006 provides general requirements for

production, labelling, test methods and performance
characteristics of biological indicators, including
inoculated carriers and suspensions, and their
components, to be used in the validation and routine
monitoring of sterilization processes.ISO
11138-1:2006 specifies basic and common
requirements that are applicable to all subsequent parts
of ISO 11138. Requirements for biological indicators
for particular specified processes are provided in the
subsequent parts of ISO 11138. If no specific
subsequent part is provided, this part applies.
Vertical
DOH-000519
3.
ISO 11138-2:2006

-- Part 2: Biological indicators for ethylene oxide
sterilization processes
2006-07-01
Horizontal

ISO 11138-2:2006 provides specific requirements for test

organisms, suspensions, inoculated carriers, biological
indicators and test methods intended for use in assessing the
performance of sterilizers and sterilization processes
employing ethylene oxide gas as the sterilizing agent, either
as pure ethylene oxide gas or mixtures of this gas with
diluent gases, at sterilizing temperatures within the range of
29 C to 65 C.
Vertical
DOH-000520
3.
ISO 11138-3:2006

-- Part 3: Biological indicators for moist heat sterilization
processes
2006-06-26
Horizontal

ISO 11138-3:2006 provides specific requirements for

test organisms, suspensions, inoculated carriers,
biological indicators and test methods intended for use
in assessing the performance of sterilization processes
employing moist heat as the sterilizing agent.
Vertical
Moist heat as the sterilizing agent is defined in ISO

11138-3:2006 as dry saturated steam. While air-steam
mixtures may be used in moist heat sterilization
processes, the methods and performance requirements
of this part of ISO 11138 might not be applicable for
biological indicators used in such processes.
DOH-000521
3.
ISO 11138-4:2006

-- Part 4: Biological indicators for dry heat sterilization
processes
2006-07-01
Horizontal

ISO 11138-4:2006 provides specific requirements for test

organisms, suspensions, inoculated carriers, biological
indicators, and test methods intended for use in assessing
the performance of sterilization processes employing dry
heat as the sterilizing agent at sterilizing temperatures
within the range of 120 C to 180 C.
Vertical
DOH-000522
2.
ISO 11138-5:2006

-- Part 5: Biological indicators for low-temperature steam
and formaldehyde sterilization processes
2006-07-01
Horizontal

ISO 11138-5:2006 provides specific requirements for

test organisms, suspensions, inoculated carriers,
biological indicators and test methods intended for use
in assessing the performance of sterilization processes
employing low-temperature steam and formaldehyde
as the sterilizing agent.
Vertical
DOH-000523
3.
ISO 11140-3:2007

-- Part 3: Class 2 indicator systems for use in the Bowie and
Dick-type steam penetration test
2007-03-15
Horizontal
Sterilization of health care products
ISO 11140-3:2007 specifies the requirements for

chemical indicators to be used in the steam penetration
test for steam sterilizers for wrapped goods, e.g.
instruments and porous materials. The indicator for
this purpose is a Class 2 indicator as described in ISO
11140-1.
Vertical
Indicators complying with ISO 11140-3:2007 are

intended for use in combination with the standard test
pack as described in EN 285. ISO 11140-3:2007 does
not consider the performance of the standard test pack,
but does specify the performance of the indicators.
DOH-000524
3.
ISO 11140-4:2007

-- Part 4: Class 2 indicators as an alternative to the Bowie
and Dick-type test for detection of steam penetration
2007-03-15
Horizontal
ISO 11140-4:2007 specifies the performance for a

Class 2 indicator to be used as an alternative to the
Bowie and Dick-type test for steam sterilizers for
wrapped health care goods (instruments, etc. and
porous loads).
Vertical
An indicator complying with ISO 11140-4:2007

incorporates a specified material which is used as a
test load. This test load may, or may not, be re-usable.
ISO 11140-4:2007 does not specify requirements for
the test load, but specifies the performance of the
indicator in combination with the test load with which
it is intended to be used. The indicator specified in
ISO 11140-4:2007 is intended to identify poor steam
penetration but does not necessarily indicate the cause
of this poor steam penetration.
DOH-000525
3.
ISO 11140-5:2007

-- Part 5: Class 2 indicators for Bowie and Dick-type air
removal tests
2007-03-15
Horizontal

Class 2 indicators for Bowie and Dick-type air
removal tests used to evaluate the effectiveness of air
removal during the pre-vacuum phase of pre-vacuum
steam sterilization cycles.
Vertical
Additionally, ISO 11140-5:2007 includes test methods and

equipment used to meet these performance requirements.
DOH-000526
3.
ISO 11737-1:2006
Sterilization of medical devices -- Microbiological methods

-- Part 1: Determination of a population of microorganisms
on products
2006-03-20
Horizontal
All devices that need to be sterile
ISO 11737-1:2006 specifies requirements and provides

guidance for the enumeration and microbial
characterization of the population of viable
micro-organisms on or in a medical device, component, raw
material or package.
Vertical
DOH-000527
3.
ISO 11737-2:1998
Sterilization of medical devices -- Microbiological methods

-- Part 2: Tests of sterility performed in the validation of a
sterilization process
1998-07-09
Horizontal
All devices that need to be sterile
This part of ISO 11737 specifies the general criteria for

tests of sterility on medical devices which have been
exposed to a treatment with the sterilizing agent that is a
fraction of the specified sterilization process. These tests are
intended to be performed when validating a sterilization
process.
Vertical
DOH-000528
3.
ISO 13408-3:2006
Aseptic processing of health care products -- Part 3:

Lyophilization
2006-09-01
Horizontal
ISO 13408-3:2006 specifies requirements for, and offers

guidance on, equipment, processes, programmes and
procedures for the control and validation of lyophilization
as an aseptic process. It does not address the
physical/chemical objectives of a lyophilization process.
Vertical
DOH-000529
3.
ISO 13408-5:2006
Aseptic processing of health care products -- Part 5:

Sterilization in place
2006-11-15
Horizontal
ISO 13408-5:2006 specifies the general requirements

for sterilization in place (SIP) applied to product
contact surfaces of the equipment used in the
manufacture of sterile health care products by aseptic
processing and offers guidance on qualification,
validation, operation and control.
Vertical
ISO 13408-5:2006 applies to processes where

sterilizing agents are delivered to the internal surfaces
of equipment that can come in contact with the
product.
DOH-000530
3.
ISO 13408-6:2005
Aseptic processing of health care products -- Part 6: Isolator

systems
2005-06-15
Horizontal

isolator systems used for aseptic processing and offers
guidance on qualification, bio-decontamination,
validation, operation and control of isolator systems
used for aseptic processing of health care products.
Vertical
ISO 13408-6:2005 is focused on the use of isolator

systems to maintain aseptic conditions; this may
include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace
national regulatory requirements, such as Good
Manufacturing Practices (GMPs) and/or compendial
requirements that pertain in particular to national or
regional jurisdictions.
DOH-000531
3.
ISO 14644-8:2006
Cleanrooms and associated controlled environments -- Part

8: Classification of airborne molecular contamination
2006-08-15
Horizontal
Cleanrooms and associated controlled environments
ISO 14644-8:2006 covers the classification of

airborne molecular contamination (AMC) in
cleanrooms and associated controlled environments in
terms of airborne concentrations of specific chemical
substances (individual, group or category) and
provides a protocol to include test methods, analysis
and time weighted factors within the specification for
classification.
Vertical
DOH-000532
2.
ISO/TS 20993:2006
Biological evaluation of medical devices -- Guidance on a

risk-management process
2006-07-26
Horizontal
All devices that contact body tissues
ISO/TS 20993:2006 describes a process by which a

manufacturer can identify the biological hazards
associated with medical devices, estimate and evaluate
the risks, control these risks and monitor the
effectiveness of the control.
Vertical
DOH-000533
3.
ANSI/AAMI ST24:1999
Automatic, general-purpose ethylene oxide sterilizers and

ethylene oxide sterilant sources intended for use in health
care facilities
2000/02/07
The Association for the Advancement of Medical

Instrumentation
Horizontal
EO sterilization equipment; ethylene oxide emission control
This standard covers minimum labeling, safety,

performance, and testing requirements for ethylene oxide
sterilizers that are intended for general-purpose use in
health care facilities and that have automatic controls. It
also covers labeling, product composition, and container
requirements for ethylene oxide sterilant sources, as well as
labeling, performance, safety, and installation requirements
for ethylene oxide emission control systems.
Vertical
DOH-000534
3.
ANSI/AAMI ST55:2003
Table-top steam sterilizers
2004/06/02/

Instrumentation
Horizontal
Table-top steam sterilizers used in health care facilities
Establishes minimum construction and performance

requirements for small table-top sterilizers that use
saturated steam as the sterilizing agent and that have a
volume less than or equal to 2 cubic feet.
Vertical
DOH-000535
3.
ANSI/AAMI ST66:1999
Sterilization of health care products Chemical indicators

Part 2: Class 2 indicators for air removal test sheets and
packs
1999/10/01

Instrumentation
Horizontal
Chemical indicators for air removal test sheets and packs

intended for use by health care facilities
This ANSI/AAMI Standard specifies the requirements for

an indicator and alternative test system used to evaluate the
effectiveness of air removal during the pre-vacuum phase of
pre-vacuum steam sterilization cycles. Additionally, this
standard includes test methods and equipment used to meet
these performance requirements.
Vertical
DOH-000536
3.
ANSI/AAMI ST77:2006
Containment devices for reusable medical device

sterilization
2007/01/16

Instrumentation
Horizontal
Containment devices, reusable rigid sterilization containers,

instrument cases, cassettes, organizing trays
This standard covers minimum labeling and performance

requirements for rigid sterilization container systems and
for instrument cases, cassettes, and organizing trays.
Vertical
DOH-000537
3.
ISO 15882:2003
Sterilization of health care products -- Chemical

indicators -- Guidance for selection, use and
interpretation of results
2003/03/15
Horizontal
Chemical indicators intended for use by health care

facilities
ISO 15882:2003 provides guidance for the selection,

use and interpretation of results of chemical indicators
used in process definition, validation, and routine
monitoring and control of sterilization processes. ISO
15882:2003 is applicable to chemical indicators for
which International Standards exist (see ISO 11140
series).
Vertical
ISO 15882:2003 is not applicable to those processes

that rely on physical removal of microorganisms, e.g.
filtration.
ISO 15882:2003 is not intended to apply to
combination processes, for example,
washer-disinfectors or flushing and steaming of
pipelines.
DOH-000538
5.
CNS 13382-1:2004
93/09/27
Horizontal
Vertical
DOH-000539
5.
CNS 13382-2:2004
93/09/27
Horizontal
---
---(
)
Vertical
DOH-000540
5.
CNS 13382-3:2004
93/09/27
Horizontal
-----
-----
()
Vertical
DOH-000541
5.
CNS 13382-4:2004
93/09/27
Horizontal
---
---(
)
Vertical
DOH-000542
5.
CNS 13382-5:2004
93/09/27
Horizontal
(
)
(2)
Vertical
DOH-000543
5.
CNS 13382-6:2004
--
93/09/27
Horizontal
--
--(
)
Vertical
DOH-000544
5.
CNS 13382-7:2004
93/09/27
Horizontal
-6 -4
-6-4
()
Vertical
DOH-000545
5.
CNS 13382-8:2004
93/09/27
Horizontal
----
---()
Vertical
DOH-000546
N.
CNS 13382-9:1995
84/01/04
Horizontal
Vertical
DOH-000547
N.
CNS 13382-10 :1995
84/01/04
Horizontal
ab
cde
fgh
Vertical
DOH-000548
N.
CNS 13382-11:1995
84/01/04
Horizontal
Vertical
DOH-000549
N.
CNS 13382-12:1995
84/01/04
Horizontal
1. CNS
2.
B
Vertical
DOH-000550
N.
CNS 13382-13:1995
84/01/04
Horizontal
Vertical
DOH-000551
N.
CNS 13382-14:1995
84/01/04
Horizontal
Vertical
DOH-000552
N.
CNS 13382-15:1995
84/07/29
Horizontal
1.
2.
A
Vertical
DOH-000553
N.
CNS 13382-16:1995
84/07/29
Horizontal
CNS 13382-13

Vertical
DOH-000554
N.
CNS 13382-17:1995
84/07/29
Horizontal
guide wires
Vertical
DOH-000555
5.
CNS 13382-18:1995
84/07/29
Horizontal
Vertical
DOH-000556
N.
CNS 13382-19:1995
84/07/29
Horizontal
per-load
50mm
Vertical
DOH-000557
N.
CNS 13382-20:1995
84/07/29
Horizontal
Vertical
DOH-000558
N.
CNS 13382-21:1995
84/07/29
Horizontal
(1) CNS 13382-20

5(1)
(2)CNS 13382-205(2)
(3)CNS 13382-205(3)
Vertical
DOH-000559
N.
CNS 13382-22:1995
84/07/29
Horizontal
Vertical
DOH-000560
N.
CNS 13382-23:1995
84/07/29
Horizontal
Vertical
DOH-000561
5.
CNS 13382-24:1996
85/07/24
Horizontal
UHMWPE
UHMWPE
Vertical
DOH-000562
5.
CNS 13382-25:1996
85/07/24
Horizontal
Vertical
DOH-000563
N.
CNS 13382-26:1996
85/07/24
Horizontal
Vertical
DOH-000564
N.
CNS 13382-27:1996
Steinmann
85/07/24
Horizontal
Steinmann
Vertical
DOH-000565
N.
CNS 13382-28:1996
85/07/24
Horizontal
U
U
Vertical
DOH-000566
N.
CNS 13382-29:1996
85/07/24
Horizontal
1
1. CNS 13382-12
CNS 13382-1[-
]/
2.
2
Vertical
DOH-000567
N.
CNS 13382-30:1996
85/07/24
Horizontal
Vertical
DOH-000568
D.
CNS 14961:2005
94/12/05
Horizontal
200 bar15
(5L)
Vertical
DOH-000569
D.
CNS 14962:2005
94/12/05
Horizontal
5LLPG
Vertical
DOH-000570
D.
CNS 14963:2005
94/12/05
Horizontal
B(1)
(2)
(3)
Vertical
DOH-000571
D.
CNS 15003-1:2006
95/04/19
Horizontal
()
()
, , ,
, , /,
, ,
CNS 15004
Vertical
DOH-000572
D.
CNS 15003-2:2006
95/04/19
Horizontal
(1)
(2) (3)
(4)
Vertical
DOH-000573
D.
CNS 15004:2006
95/04/19
Horizontal
(pressure swing adsorber, PSA)

CNS
15003-1ISO 7396-1
Vertical
DOH-000574
D.
CNS 15005-1:2006
95/04/19
Horizontal
CNS 15003-1 ( ISO 7396-1 )

/[50%50% ()]

(NIST)ISO
5359
(AGSS)
CNS 15005-2 ( ISO 9170-2 )
Vertical
DOH-000575
D.
CNS 15005-2:2006
95/04/19
Horizontal
CNS
15003-2ISO 7396-2
Vertical
DOH-000576
D.
CNS 15006:2006
95/04/19
Horizontal

1.2

/
50/50 (%)1.3
Vertical
DOH-000577
4.
ISO/IEC 25000-1:2007
Software engineering - Software product Quality

Requirements and Evaluation (SQuaRE) - Planning and
management
2007-01-16
Horizontal
Software development and system documentation
ISO/IEC 25001:2007 provides details about the planning

and management requirements associated with software
product quality requirements and evaluation. While it is
mainly concerned with product quality requirements and
evaluation, wherever it is relevant the corresponding
process requirements and evaluation activities are also
discussed. ISO/IEC 25001:2007 aims to clarify the
requirements which should be identified by the organization
in order to ensure the success of specifying quality
requirements and executing the evaluation. ISO/IEC
25001:2007 is intended to be used in conjunction with the
other parts of the SQuaRE series (ISO/IEC 25000-ISO/IEC
25051) of International Standards, and with ISO/IEC 14598
and ISO/IEC 9126-1 until superseded by the ISO/IEC
25000 series of International Standards. ISO/IEC
25001:2007 complies with the technical processes
identified in ISO/IEC 15288 related to quality requirements
definition and analysis.
Vertical
DOH-000578
1.
IEC 60601-1-2 :2007
Medical electrical equipment - Part 1-2: General

requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests
2007-03-30
Horizontal
Medical equipment in general
This collateral standard applies to electromagnetic

compatibility of medical electrical equipment and medical
electrical systems.
The object of this collateral standard is to specify general
requirements and tests for electromagnetic compatibility of
medical electrical equipment and medical electrical
systems. They are in addition to the requirements of the
general standard and serve as the basis for particular
standards.
This edition of IEC 60601-1-2 was revised to structurally
align it with the 2005 edition of IEC 60601-1 and to
implement the decision of IEC subcommittee 62A that the
clause numbering structure of collateral standards written to
IEC 60601-1:2005 would adhere to the form specified in
ISO/IEC Directives, Part 2:2004. The principle technical
changes are in Clause 4, which now recognizes that there is
a general requirement for a risk management process in IEC
60601-1:2005.
Vertical
DOH-000579
1.
IEC 60601-1-6:2006
Medical electrical equipment - Part 1-6: General

requirements for basic safety and essential performance Collateral standard: Usability
2006-12-08
Horizontal
All Medical equipment
Specifies requirements for a process to analyse, design,

verify and validate the usability, as it relates to basic safety
and essential performance of medical electrical equipment.
This collateral standard addresses normal use and use errors
but excludes abnormal use.
The object of this collateral standard is to specify general
requirements that are in addition to those of the general
standard IEC 60601-1 and to serve as the basis for
particular standards.
Vertical
DOH-000580
P.
CEI/IEC 60601-2-22:1995
Medical electrical equipment - Part 2-22: Particular

requirements for the safety of diagnostic and therapeutic
laser equipment
1995-11
Horizontal
Radiographic equipment
Applies to the basic safety and essential performance of

laser equipment for either surgical, therapeutic, medical
diagnostic, cosmetic, or veterinary applications, intended
for its use on humans or animals, classified as a class 3B or
class 4 laser product as defined by 3.22 and 3.23 in IEC
60825-1, hereafter referred to as laser equipment.
Throughout this International Standard, light emitting
diodes (LED) are included whenever the word 'laser' is
used.
This standard can also be applied to surgical, cosmetic,
therapeutic and diagnostic laser equipment used for
compensation or alleviation of disease, injury or disability.
This third edition cancels and replaces the second edition of
IEC 60601-2-22, published in 1995. This edition constitutes
a technical revision.
This third edition takes account of the recently published
new editions of the General Standard IEC 60601-1 and
Group safety publication IEC 60825-1. Additionally, it
addresses technical and safety issues which have arisen in
the time following the previous second edition.
Vertical
DOH-000581
P.
IEC 60601-2-45 :2001
Medical electrical equipment Part 2-45: Particular

requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
2001-05
Horizontal
Radiographic equipment
The object of this standard is

1. to formulate appropriate design and manufacturing
requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices,
reflecting the particular characteristics and circumstances of
use of such equipment;
2. to establish particular requirements to ensure safety and
to specify methods for demonstrating compliance with
those requirements.
Vertical
DOH-000582
1.
IEC 61326-1:2005

laboratory use - EMC requirements - Part 1: General
requirements
2005-12-15
Horizontal

laboratory use
This standard specifies requirements for immunity and

emissions regarding electromagnetic compatibility (EMC)
for electrical equipment, operating from a supply or battery
of less than 1 000 V a.c. or 1 500 V d.c. or from the circuit
being measured, intended for professional,
industrial-process, industrial-manufacturing and educational
use, including equipment and computing devices.
Vertical
DOH-000583
P.
IEC/TR 60825-8:2006
Safety of laser products - Part 8: Guidelines for the safe use

of laser beams on humans
2006-12-08
Horizontal
Optoelectronics. Laser equipment
This part of IEC 60825 serves as a guide to the employer,

the responsible organisation, the laser safety officer, the
laser operator and other persons involved, on the safe use of
lasers and laser equipment classified as class 3B or class 4.
It covers all applications of laser beams on humans in, but
not limited to, health-care facilities, cosmetic and hair
removal centres and dental practices, including applications
in vehicles and domestic premises.
This technical report explains the control measures
recommended for the safety of patients, staff, maintenance
personnel and others. Engineering controls which form part
of the laser equipment or the installation are also briefly
described to provide an understanding of the general
principles of protection.
The subject areas covered in this guide include
- beam delivery systems;
- biological effects of laser radiation;
- reporting of accidents and dangerous situations;
- checklists.
The object of this report is to enhance the protection of
persons from laser radiation and other associated hazards by
providing guidance on how to establish safety procedures,
precautions and user control measures.
Vertical
DOH-000584
1.
IEC/TR 62354:2005
General testing procedures for medical electrical equipment
2005-12-15
Horizontal
All medical electrical equipments.
This Technical Report applies to medical electrical

equipment as defined in IEC 60601-1. Its object is to
provide guidance on general testing procedures according to
IEC 60601-1.
Vertical
DOH-000585
1.
ISO 12052:2006
Health informatics -- Digital imaging and communication in

medicine (DICOM) including workflow and data
management
2006-10-20
Horizontal
Health informatics
Within the field of health informatics this ISO

12052:2006 addresses the exchange of digital images,
and information related to the production and
management of those images, between both medical
imaging equipment and systems concerned with the
management and communication of that information.
Vertical
ISO 12052:2006 is intended to facilitate

interoperability of medical imaging equipment and
information systems by specifying:
a set of protocols to be followed by systems

claiming conformance to this International
Standard.
the syntax and semantics of commands and
associated information data models that ensure
effective communication between
implementations of this International Standard;
information that shall be supplied with an
implementation for which conformance to this
International Standard is claimed.
DOH-000586
4.
ISO/IEC 25051:2006
Software engineering -- Software product Quality

Requirements and Evaluation (SQuaRE) -- Requirements
for quality of Commercial Off-The-Shelf (COTS) software
product and instructions for testing
2006-03-31
Horizontal
ISO/IEC 25051:2006 defines quality requirements for

COTS software products. A COTS software product
includes the product description, the user documentation,
and the software contained on a computer sensible media.
The quality requirements, functionality, reliability, usability,
efficiency, maintainability, portability, and quality in use are
consistent with the definitions of SQuaRE. In addition to
the quality requirements, ISO/IEC 25051:2006 also defines
requirements for test documentation. The test
documentation purpose is to demonstrate the conformity of
the software with the requirements. The documentation
contains a test plan, the description of the tests cases, and
the tests results. ISO/IEC 25051:2006 can be used by
suppliers, certification bodies, testing laboratories,
accreditation bodies, regulatory authorities and acquirers.
Vertical
DOH-000587
4.
ISO/IEC 25062:2006
Software engineering -- Software product Quality

Requirements and Evaluation (SQuaRE) -- Common
Industry Format (CIF) for usability test reports
2006-03-31
Horizontal
ISO/IEC 25062:2006 provides a standard method for

reporting usability test findings. The format is designed for
reporting results of formal usability tests in which
quantitative measurements were collected, and is
particularly appropriate for summative/comparative testing.
The CIF does not indicate how to perform a usability test
but provides guidance on how to report the results of a
usability test. The CIF targets two audiences: usability
professionals and stakeholders in an organization.
Stakeholders can use the usability data to help make
informed decisions concerning the release of software
products or the procurement of such products. The format
includes the following elements: - the description of the
product, - the goals of the test, - the test participants - the
tasks the users were asked to perform, - the experimental
design of the test, - the method or process by which the test
was conducted, - the usability measures and data collection
methods, and - the numerical results.
Vertical
DOH-000588
J.
CNS 15036-1:2006
95/10/31
Horizontal
(
)
/
Vertical
DOH-000589
J.
CNS 13460:1994
83/12/01
Horizontal
0.3 ~ 5MHz
50W
Vertical
DOH-000590
J.
CNS 14624-1 :2002
91/03/07
Horizontal
ISO 4802-l ISO 4802-2
Vertical
DOH-000591
J.
CNS 14624-2 :2002
91/03/07
Horizontal
CNS l4624-l-
Vertical
DOH-000592
J.
CNS 14624-3:2002
91/03/07
Horizontal
CNS l4624-l
Vertical
DOH-000593
J.
CNS 14624-4:2002
91/03/07
Horizontal
Vertical
DOH-000594
J.
CNS 14624-5:2002
91/03/07
Horizontal
50 mll00 ml l50 ml
Vertical
DOH-000595
J.
CNS 14624-6 :2002
91/03/07
Horizontal
CNS l4624-l-
Vertical
DOH-000596
J.
CNS 14624-7:2002
91/03/07
Horizontal
CNS l4624-1-
Vertical
DOH-000597
J.
ISO 15883-1:2006
Washer-disinfectors -- Part 1: General requirements, terms

and definitions and tests
2006-04-06
Horizontal
Sterilizing equipment
ISO 15883-1:2006 specifies general performance

requirements for washer-disinfectors (WD) and their
accessories that are intended to be used for cleaning and
disinfection of re-usable medical devices and other articles
used in the context of medical, dental, pharmaceutical and
veterinary practice. It specifies performance requirements
for cleaning and disinfection as well as for the accessories
which can be required to achieve the necessary
performance. The methods and instrumentation required for
validation, routine control and monitoring and re-validation,
periodically and after essential repairs, are also specified.
Vertical
DOH-000598
J.
ISO 15883-2:2006
Washer-disinfectors -- Part 2: Requirements and tests for

washer-disinfectors employing thermal disinfection for
surgical instruments, anaesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc.
2006-04-06
Horizontal
This part of ISO 15883 specifies particular requirements for

washer-disinfectors (WD) that are intended for use for the
cleaning and thermal disinfection, in a single operating
cycle, of re-usable medical devices such as surgical
instruments, anaesthetic equipment, bowls, dishes and
receivers, utensils and glassware.
Vertical
DOH-000599
J.
ISO 15883-3:2006
Washer-disinfectors -- Part 3: Requirements and tests for

washer-disinfectors employing thermal disinfection for
human waste containers
2006-04-06
Horizontal
ISO 15883-3:2006 specifies particular requirements

for washer-disinfectors (WD) that are intended to be
used for emptying, flushing, cleaning and thermal
disinfection of containers used to hold human waste
for disposal by one operating cycle.
Vertical
ISO 15883-3:2006 is to be applied in conjunction with

ISO 15883-1.
DOH-000600
J.
ISO/TS 15883-5:2005
Washer-disinfectors -- Part 5: Test soils and methods for

demonstrating cleaning efficacy
2005-11-23
Horizontal
ISO/TS 15883-5:2005 includes the test soils and

methods that can be used to demonstrate the cleaning
efficacy of washer-disinfectors (WD) according to the
ISO 15883 series of standards.
Vertical
The inclusion of the test soils and methods in ISO/TS

15883-5:2005 does not indicate that they are of
equivalent sensitivity in their determination of
cleaning efficacy.
Acceptance criteria are included, based on visual
inspection and/or a microbiological end-point as stated
for each method. Where chemical detection of residual
soiling is required/sought, methods can be
complemented by the specific determination of a
residual component of the applied test soil.
DOH-000601
J.
D6499-03
Standard Test Method for The Immunological Measurement

of Antigenic Protein in Natural Rubber and its Products
2003-06
ASTM International
Horizontal
Rubber Examination Gloves
1.1 This test method covers an immunological method to

determine the amount of antigenic protein in natural rubber
and its products using rabbit antisera specific for natural
rubber latex (NRL) proteins. This immunoassay procedure
quantitatively measures the level of antigenic latex proteins
in solution using an inhibition format. The samples may
include glove or other rubber product extracts which have
been collected in order to measure the latex protein levels.
Although this method detects antigenic proteins, it should
not be considered as a measure of allergenic proteins.
Correlation of protein/antigen levels with the level of
allergenic proteins has not been fully established.
Vertical
1.2 For the purpose of this test method, the range of protein
will be measured in terms of microgram to milligram
quantities.
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish
appropriate safety and health practices and determine the
applicability of regulatory limitations prior to use.
DOH-000602
J.
E1104-98(R2003)
Standard Specification for Clinical Thermometer Probe

Covers and Sheaths1
2003-5-10
ASTM International
Horizontal
All single-use clinical thermometer probe covers and

sheaths
1.1 This specification covers all single-use clinical

thermometer probe covers and sheaths intended for use with
any clinical thermometer. Requirements are given for
safety, toxicity, handling, labeling, and physical integrity.
Testing procedures for appropriate requirements and a
glossary of terms used within the standards are provided.
Vertical
1.2 The requirements contained herein are intended to

ensure adequate isolation of the patient from the
temperature-measuring device. In addition, the safety and
health of the patient shall not be adversely affected. When
used in accordance with the manufacturers instructions, the
probe cover, sheath, and temperature measuring device
shall remit correct temperature readings as required in
Specifications E 667 and E 1112.
DOH-000603
J.
E196598 (R2003)
Standard Specification for Infrared Thermometers for

Intermittent Determination of Patient Temperature
2003-5-10
ASTM International
Horizontal
Infra red ear & surface thermometers
1.1 This specification covers electronic instruments intended for intermittent

measuring and monitoring of patient temperatures by means of detecting the
intensity of thermal radiation between the subject of measurement and the sensor.
Vertical
1.2 The specification addresses assessing subject's body internal temperature

through measurement of thermal emission from the ear canal. Performance
requirements for noncontact temperature measurement of skin are also provided.
1.3 The specification sets limits for laboratory accuracy and requires determination
and disclosure of clinical accuracy of the covered instruments.
1.4 Performance and storage limits under various environmental conditions,
requirements for labeling and test procedures are established.
Note 1For electrical safety consult Underwriters Laboratory Standards.
Note 2For electromagnetic emission requirements and tests refer to CISPR 11:
1990 Lists of Methods of Measurement of Electromagnetic Disturbance
Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency
Equipment.
1.5 The values of quantities stated in SI units are to be regarded as the standard. The
values of quantities in parentheses are not in SI and are optional.
1.6 The following precautionary caveat pertains only to the test method portion,
Section 6, of this specification: This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the responsibility of the user of
this standard to establish appropriate safety and health practices and determine the
DOH-000604
E.
F2081-01
Standard Guide for Characterization and Presentation of the

Dimensional Attributes of Vascular Stents
2001-04
ASTM International
Horizontal
All stents indicated for intravascular vascular placement
This guide covers the identification of and recommended

measurement methods for those dimensional attributes of
vascular stents that are deemed relevant to successful
clinical performance. The delivery system packaged with
and labeled specifically for use during the placement of the
stent is also included within the scope of this guide.
Vertical
DOH-000605
K.
F64794 (R2000)
Standard Practice for Evaluating and Specifying

Implantable Shunt Assemblies for Neurosurgical
Application
1994-8
ASTM International
Horizontal
Neurological Shunt Assemblies for Neurological

Applications
1.1 This practice covers requirements for the evaluation and

specification of implantable shunts as related to resistance to flow,
direction of flow, materials, radiopacity, mechanical properties,
finish, sterility, and labeling of shunt assemblies.
Vertical
1.2 Devices to which this practice is applicable include, but are not
limited to, those that are temporarily implanted to effect external
drainage; or permanently implanted to effect shunting of fluid from a
cerebral ventricle, a cyst, the subarachnoid space to the peritoneal
cavity, the venous circulation, or some other suitable internal delivery
site, and intracranial bypass.
1.3 Limitations-- Although this practice includes a standard test
method for the evaluation of pressure/flow characteristics of shunts or
shunt components, it does not include specific pressure/flow
requirements.
1.4 The following components, that individually or in combination
comprise shunt assemblies, are considered to be within the scope of
this practice: catheters (such as atrial, peritoneal, ventricular),
connectors, implantable accessory devices (such as antisiphon devices
and reservoirs), valved catheters and valves.
1.5 This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility of the
user of this standard to establish appropriate safety and health
practices and determine the applicability of regulatory limitations
prior to use.
DOH-000606
J.
F88194 (R2000)
Standard Specification for Silicone Elastomer Facial

Implants
1994-07
ASTM International
Horizontal
Facial Implants
1.1 This specification covers the requirements for silicone

elastomer implants used in facial surgery (that is, chin,
nasal, malar, and ear implants).
Vertical
1.2 Limitations--This specification does not cover implants

containing silicone gels or other gels or liquids. It does not
necessarily cover any custom-fabricated prosthesis
manufactured to any other specification.
1.3 The following safety hazards caveat pertains only to the
mechanical testing and test methods portion, Section 7, of
this specification: This standard does not purport to address
all of the safety problems, if any, associated with its use. It
is the responsibility of the user of this standard to establish
appropriate safety and health practices and determine the
DOH-000607
K.
F154294 (R2000)
Standard Specification for the Requirements and Disclosure

of Self-Closing Aneurysm Clips
1994-10
ASTM International
Horizontal
Self-Closing Aneurysm Clips
1.1 This specification covers requirements for the specific

characteristics of self-closing aneurysm clips that are
intended for permanent implantation. Appropriate test
requirements are also included.
Vertical
1.2 Since all of the properties that contribute to aneurysm

clip performance may not be known, this specification is
intended to reflect the state of our knowledge to date.
1.3 Miniatures of "microclips" that are not intended for the
obliteration of aneurysms are excluded from this
specification.
DOH-000608
J.
F167003
Standard Test Method for Resistance of Materials Used in

Protective Clothing to Penetration by Synthetic Blood
2003-10
ASTM International
Horizontal
Gowns and Drapes
This test method is used to evaluate the resistance of

materials used in protective clothing to penetration by
synthetic blood under conditions of continuous liquid
contact. Protective clothing pass/fail determinations are
based on visual detection of synthetic blood penetration
Vertical
DOH-000609
J.
F167103
Standard Test Method for Resistance of Materials Used in

Protective Clothing to Penetration by Blood-Borne
Pathogens Using Phi-X174 Bacteriophage Penetration as a
Test System
2003-10
ASTM International
Horizontal
Gowns & Drapes
This test method is used to measure the resistance of

materials used in protective clothing to penetration by
blood-borne pathogens using a surrogate microbe under
conditions of continuous liquid contact. Protective clothing
material pass/fail determinations are based on the detection
of viral penetration.
Vertical
DOH-000610
J.
BF7:1989/(R)2002
Blood transfusion micro-filters
2002-1-31

Instrumentation
Horizontal
All blood transfusion micro-filters for adults only
This standard contains labeling requirements, performance

requirements, test methods, and terminology for disposable
blood transfusion micro-filters for use with adult
populations to remove microaggregates from blood or blood
products during transfusion.
Vertical
DOH-000611
J.
BP22:1994/(R)2001
Blood pressure transducers
1994-08-30

Instrumentation
Horizontal
Blood pressure transducers
Specifies safety and performance requirements for

transducers, including cables, designed for blood pressure
measurements through an indwelling catheter or direct
puncture and disclosure requirements to permit the user to
determine compatibility between the transducer and blood
pressure monitor.
Vertical
DOH-000612
E.
DF80:2003
Medical electrical equipmentPart 2-4: Particular

requirements for the safety of cardiac defibrillators
(including automated external defibrillators)
2003-10-23

Instrumentation
Horizontal
Cardiac defibrillators
Specifies requirements for the safety of medical electrical

equipment intended to defibrillate the heart by an electrical
pulse via electrodes applied either to the patient's skin
(external electrodes) or to the exposed heart (internal
electrodes). This standard does not apply to implantable
defibrillators, remote control defibrillators or separate
cardiac monitors.
Vertical
DOH-000613
E.
EC11:1991/(R)2001
Diagnostic electrocardiographic devices
2001-05-04

Instrumentation
Horizontal
ELECTROCARDIOGRAPHIC (ECG) SYSTEMS WITH

DIRECT WRITING DEVICES
Establishes minimum safety and performance requirements

for electrocardiographic (ECG) systems with direct writing
devices which are intended for use in the analysis of rhythm
and of detailed morphology of complex cardiac complexes.
Subject to this standard are all parts of the
electrocardiographic system necessary to obtain the signal
from the surface of the patient's body, to amplify this signal,
and to display it in a form suitable for diagnosing the heart's
electrical activity. This standard defines requirements for
the electrocardiographic recording system, from the input
electrodes to the output display.
Vertical
DOH-000614
E.
EC12:2000/(R)2005
Disposable ECG electrodes
2005-01-06

Instrumentation
Horizontal
Disposable ECG Electrodes
This standard establishes contains minimum labeling, safety

and performance requirements; test methods; and
terminology for disposable electrocardiographic (ECG)
electrodes.
Vertical
DOH-000615
E.
EC53:1995/(R)2001
ECG cables and leadwires
2001-05-11

Instrumentation
Horizontal
Electrode Leadwires and Patient Cables intended for use

with the following devices: Electrocardiographs (ECGS),
Cardiac Monitors, Arrhythmia Detectors and Alarms, DC
Defibrillators, Multiparameter Physiological Monitors,
Breathing Frequency Monitors, Ventilatory Effort Monitors
(Apnea Detectors), Other devices that use patient cables
Covers safety and performance requirements for disposable
and reusable leadwires as well as the cables used for surface
electrocardiographic (ECG) monitoring in cardiac monitors.
Also specifies a standard leadwire/trunk cable interface to
allow interchangeability.
Vertical
DOH-000616
E.
EC57:1998/(R)2003
Testing and reporting performance results of cardiac rhythm

and ST-segment measurement algorithms
2003-12-18

Instrumentation
Horizontal
Arrhythmia detectors and alarms, cardiac monitors and

electrocardiographs
This recommended practice established a method for testing

and reporting the performance of algorithms used to detect
cardiac rhythm disturbances, including the ST segment.
Vertical
DOH-000617
K.
60601-2-23:1999
Medical electrical equipment-Part 2-23: Particular

requirements for the safety, including essential
performance, of transcutaneous partial pressure monitoring
equipment
1999-12-10
Horizontal
Transcutaneous oxygen and carbon dioxide partial pressure

monitors
Specifies requirements for the safety, including essential

performance, of transcutaneous partial pressure monitoring
equipment, whether this equipment is stand alone or part of
a system.
Applies to transcutaneous monitors used with adults,
children and neonates, and it includes the use of these
devices in foetal monitoring during birth.
Vertical
DOH-000618
E.
60601-2-27:1994
Medical electrical equipment- Part 2: Particular

requirements for the safety of electrocardiographic
monitoring equipment
1994-03
Horizontal
Electrocardiographs
Specifies the particular safety requirements, including

essential performance, for electrocardiographic (ECG)
monitoring equipment. This standard is applicable to
equipment used in a hospital environment.
If the equipment is used outside the hospital environment,
such as in ambulances and air transport, the equipment shall
comply with this standard.
Vertical
DOH-000619
E.
60601-2-30:1999
Medical electrical equipment- Part 2-30: Particular

requirements for safety, including essential performance, of
automatic cycling non-invasive blood pressure monitoring
equipment
1999-12-22
Horizontal
Non-invasive Blood Pressure Monitors
Specifies particular requirements for the safety, including

essential performance, of automatic cycling non-invasive
blood pressure monitoring equipment, with special attention
being paid to the avoidance of hazards due to the inflation
process.
Vertical
DOH-000620
E.
60601-2-34:2000
Medical electrical equipment Part 2-34: Particular

requirements for the safety, including essential
performance, of invasive blood pressure monitoring
equipment
2000-10
Horizontal
Invasive blood pressure monitors, including transducers
Establishes particular requirements for the safety, including

the essential performance of invasive blood pressure
monitoring and measuring equipment.
This particular standard takes into account Collateral
Standard 60601-1-2:(1993) Electromagnetic compatibility
and Collateral Standard 60601-1-4:(1996) Medical
electrical equipment incorporating programmable electrical
systems.
A section on alarms has been included because alarms are
necessary for monitoring equipment.
Vertical
DOH-000621
J.
60601-2-38:1996/Amd.1, 1999
Medical electrical equipment - Part 2-38: Particular

requirements for the safety of electrically operated hospital
beds
1999-12-17
Horizontal
Electrical Hospital Beds
Specifies requirements for safety of electrically operated

hospital beds. The object of this standard is to keep the
safety hazards to patients, operators and the environment as
low as possible, and to describe tests to verify that these
requirements are attained.
Vertical
DOH-000622
J.
594-1:1986
Conical fittings with a 6% (Luer) taper for syringes, needles

and certain other medical equipment - Part 1: General
requirements
1986-06-15
Horizontal
All luer taper pistons syringes & hypodermic single lumen

needles
Specification of the requirements for conical (Luer)

fittings for use with hyperdemic syringes and needles
and with certain other apparatus for medical use such
as transfusion and infusion sets. It covers fittings made
of rigid and semi-rigid materials and includes test
methods for gauging and performance. It excludes
provision for more flexible or elastomeric materials.
The annex on liquid leakage is given as an example.
Vertical
DOH-000623
J.
594-2:1998
Conical fittings with a 6% (Luer) taper for syringes, needles

and certain other medical equipment - Part 2: Lock fittings
1998-09-01
Horizontal
All Luer Taper piston, syringes, & hypodermic single lumen

needles
This part of ISO 594 specifies requirements for conical lock

fittings with a 6 % (Luer) taper for use with hypodermic
syringes and needles and with certain other apparatus for
medical use, e.g. transfusion equipment.
Vertical
The requirements apply to fittings made of rigid and of

semi-rigid materials and include test methods, but exclude
provision for more flexible or elastomeric materials.
NOTE 1 It is not practicable to define the characteristics of
rigid or semi-rigid materials with precision, but glass and
metal may be considered as typical rigid materials. In
contrast many plastics materials may be regarded as
semi-rigid.
NOTE 2 The Luer lock fitting was designed for use at
pressures of the order of 300 kPa or lower. Its use in other
applications may require consideration to establish its
suitability.
DOH-000624
E.
5841-1:1989
Cardiac Pacemakers - Part 1 : Implantable Pacemakers
1989-11-15
Horizontal
Implantable pacemakers, pacemaker lead and pacemaker

lead adapters
This part of ISO 5841 establishes basic terminology and

definitions, and specifies requirements for marking
implantable cardiac Pacemakers and their packaging.
Vertical
Minimum requirements for the ability of Pacemaker pulse

generators to withstand environmental stress conditions are
also specified along with appropriate test methods.
DOH-000625
E.
5841-2:2000
Implants for surgery Cardiac pacemakers Part

2:Reporting of clinical performance of populations of pulse
generators or leads
2000-10-15
Horizontal

lead adapters
This part of ISO 5841 specifies requirements for reports on

the clinical performance in humans of population samples
of pulse generators or leads, intended for long-term
implantation as cardiac pacemakers, hereinafter referred to
as devices. It includes general requirements for all reports
and supplementary requirements for reports on cumulative
experience with devices and estimates of future clinical
performance for devices, when appropriate.
Vertical
DOH-000626
E.
5841-3:2000
Implants for surgery Cardiac pacemakers Part 3:

Low-profile connectors [IS-1] for implantable pacemakers
2000-10-15
Horizontal

lead adapters
This part of ISO 5841 specifies a connector assembly to be

used to connect implantable pacemaker leads to implantable
pacemaker pulse generators. Essential dimensions and
performance requirements related to connector fit are
specified, together with appropriate test methods.
Vertical
Other connector features such as fastening means and

materials are not specified in this part of ISO 5841. This
part of ISO 5841 is applicable only to the form and fit of the
connector assembly, and does not address all aspects of
functional compatibility, system performance or reliability
of different leads and pulse generator assemblies.
This part of ISO 5841 supplements ISO 5841-1 only for
those pacemaker components which are claimed by their
labeling to be fitted with an IS-1 connector assembly part. It
does not replace any requirements in ISO 5841-1.
DOH-000627
K.
7197:1997
Neurosurgical implants Sterile, single use hydrocephalus

shunts and components
1997-11-01
Horizontal
Sterile, single use hydrocephalus shunts and components

including:
a. one piece type,
b. multipiece type either assembled or in kit form,
c. individual shunt components or in combination.
This International Standard specifies requirements for
sterile, single-use hydrocephalus shunts and components.
Vertical
This International Standard is applicable to but is not

limited to:
a) complete sterile, single-use hydrocephalus shunts of the
one-piece type; or
b) complete sterile, single-use hydrocephalus shunts of the
multipiece type, supplied either assembled by the
manufacturer or in kit form for assembly by the physician;
or
c) sterile, single-use shunt components which (individually
or in combination) comprise shunt assemblies, for example:
valves, valved catheters (catheter with integral valves),
inflow or outflow catheters (such as arterial, peritoneal,
ventricular catheters), connectors, implantable accessory
devices (such as siphoning-preventing devices, measuring
devices and reservoirs/priming devices).
DOH-000628
J.
8537:1991/Amd.1, 2000
Sterile single-use syringes, with or without needle, for

insulin
2000-11-01
Horizontal
All Insulin Syringes
This International Standard specifies requirements and test

methods for sterile syringes with or without needles
intended for single use solely for the injection of insulin and
primarily in humans. It covers syringes for use with 40 units
of insulin/ml (U-40) and 100 units of insulinml (U-100).
Vertical
Sterile syringes specified in this International Standard are

intended for use soon after filling as they
are not suitable for containing insulin over extended periods
of time.
DOH-000629
K.
NS28:1988/(R)2001
Intracranial pressure monitoring devices
2001-07-23

Instrumentation
Horizontal
Intracranial Pressure (ICP) Monitors
This standard establishes minimum labeling, safety, and

performance requirements for intracranial pressure
monitoring devices, whether percutaneous, fully
implantable, or noninvasive. Also covered are referee test
methods and the rationale for the provisions of the standard.
Vertical
DOH-000630
J.
PB70:2003
Liquid barrier performance and classification of protective

apparel and drapes intended for use in health care facilities
2003-10-23

Instrumentation
Horizontal
Surgical Gowns and Surgical Drapes
This standard establishes a system of classification for

protective apparel and drapes used in health care facilities
based on their liquid barrier performance and specifies
related labeling requirements and standardized test methods
for determining compliance. By specifying a consistent
basis for testing and labeling protective apparel and drapes
and providing a common understanding of barrier
properties (e.g., efficacy against liquid or liquidborne
microorganism penetration) based on this new classification
system, the standard is intended to ultimately assist
end-users in determining the types of protective product
most appropriate for a particular task or situation.
Vertical
DOH-000631
E.
SP10:2002/A1:2003
Manual, electronic, or automated sphygmomanometers
2002-10-28

Instrumentation
Horizontal
Non-invasive blood pressure monitors, including blood

pressure cuffs
This standard establishes labeling, safety, and performance

requirements for sphygmomanometers, including
electronic, electromechanical, and nonautomated devices
that are used in the indirect measurement of blood pressure.
Ambulatory blood pressure monitors, which are portable,
lightweight, automated devices worn or carried by the
patient that are able to obtain and store the results of
repeated determinations of blood pressure and heart rate
during activities of ordinary daily living, also are included
in the scope of this document.
Vertical
DOH-000632
J.
ANSI/AAMI II:36:1997
Infant incubators
1997/09/15

Instrumentation
Horizontal
Include all infant incubators except transport incubators
This standard delineates requirements for infant incubator

labeling and performance, which are intended to minimize
risks to patient and user, and establishes referee tests by
which the requirements can be verified.
Vertical
DOH-000633
H. -
ANSI/AAMI RD5:2003
Hemodialysis systems
2007/11/08

Instrumentation
Horizontal
Dialysis equipment
Covers apparatus for preparing dialysate, monitors of the

dialysate, and accessories for monitoring the extracorporeal
blood circuit. The requirements established by this standard
will, at a minimum, help ensure the effective, safe
performance of hemodialysis systems, devices, and related
materials.
Vertical
DOH-000634
H. -
ANSI/AAMI RD16:2007
Cardiovascular implants and artificial organs Hemodialyzers, hemodiafilters, hemofilters and

hemoconcentrators
2007/07/18

Instrumentation
Horizontal
Hemodialyzers, hemoconcentrators, Hemofilters,

hemodiafilters
Specifies requirements for hemodialyzers, hemodiafilters,

hemofilters and hemoconcentrators for use for humans;
includes biological safety, sterility, nonpyrogenicity,
mechanical and performance characteristics, and labeling.
Vertical
DOH-000635
H. -
ANSI/AAMI RD17:2007
Cardiovascular implants and artificial organs Extracorporeal blood circuit for hemodialyzers,
hemodiafilters and hemofilters
2007/07/19

Instrumentation
Horizontal
Hemodialzer blood tubing
Specifies requirements for the single use extracorporeal

blood circuit and non-integral transducer protectors that are
intended for use in hemodialysis, hemodiafiltration,
hemofiltration, and hemoconcentration; includes biological
safety, sterility, nonpyrogenicity, mechanical and physical
characteristics, and labeling.
Vertical
DOH-000636
H. -
ANSI/AAMI RD47:2002 & RD47:2002/A1:2003
Reuse of hemodialyzers
2003/04/25

Instrumentation
Horizontal
Dialysis equipment, hemodialyzers
Addressed to physicians and other health care facility

personnel, this recommended practice describes the
essential elements of good practices for reprocessing
hemodialyzers in order to help ensure device safety and
effectiveness. Specifically, the document covers personnel
and patient considerations, records, equipment, physical
plant and environmental safety, reprocessing material,
patient identification and hemodialyzer labeling,
reprocessing and storage procedures, disposition of rejected
dialyzers, preparation for subsequent use, patient
monitoring, quality assurance and quality control.
Vertical
DOH-000637
H. -
ANSI/AAMI RD52:2004
Dialysate for hemodialysis
2004/09/16

Instrumentation
Horizontal
Dialysis equipment, dialyzing fluid
Covers the appropriate preparation of dialysate, handling of

concentrates, operation of water treatment equipment and
handling of its product water, monitoring of systems and the
dialysate produced, and risks and hazards of dialysate
preparation failure.
Vertical
DOH-000638
H. -
ANSI/AAMI RD61:2006
Concentrates for hemodialysis
2007/05/04

Instrumentation
Horizontal
Concentrates for hemodialysis
This AAMI standard specifies manufacturing, labeling, and

testing requirements for concentratesto be diluted for use as
dialysate in hemodialysis.
Vertical
DOH-000639
H. -
ANSI/AAMI RD62:2006
Water treatment equipment for hemodialysis applications
2007/01/06

Instrumentation
Horizontal
Hemodialysis Water Purification Systems for Dialysis
Covers devices used to treat water intended for use in the

delivery of hemodialysis. Included in the scope of the
standard is water used for: (1) the preparation of
concentrates from powder at a dialysis facility, (2) the
preparation of dialysate, and (3) the reprocessing of
dialyzers for multiple use.
Vertical
DOH-000640
J.
ISO 7886-2:1996
Sterile hypodermic syringes for single use - Part 2: Syringes

for use with power-driven syringe pumps
1996/05/15
Horizontal
Syringes, Infusion Pumps
Specifies requirements for sterile single-use

hypodermic syringes of nominal capacity 5 ml and
above, made of plastics materials and intended for use
with power-driven syringe pumps. Does not apply to
syringes for use with insulin, single-use syringes made
of glass, syringes prefilled with the injection by the
manufacturer and syringes supplied with the injection
as a doctors kid.
Vertical
DOH-000641
J.
ISO 10555-3:1996/ Cor.1:2002
Sterile, single-use intravascular catheters - Part 3: Central

venous catheters
2002/06/15
Horizontal
Central Venous Catheters
This part of IS0 10555 specifies requirements for central

venous catheters supplied in the sterile condition, and
intended for single use.
Vertical
DOH-000642
J.
ISO 10555-5:1996/Amd.1:1999, Cor.1:2002
Sterile, single-use intravascular catheters - Part 5:

Over-needle peripheral catheters
2002/06/15
Horizontal
Single use Intravascular Catheters
This part of ISO 10555 specifies requirements for

over-the-needle peripheral intravascular catheters, in-tended
for accessing the peripheral vascular system, supplied in the
sterile condition and intended for single use.
Vertical
DOH-000643
ABC.
CNS 13075:2007
96/01/19
Horizontal
()
Vertical

97年度醫療器材採認標準資料單

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

97年度醫療器材採認標準資料單

Uploaded by

Copyright:

Available Formats

DOH-000479

Electrical equipment for measurement, control and

International Electrotechnical Commission

In vitro diagnostic (IVD) medical equipment

Specifies minimum requirements for immunity and

Point-of-care testing (POCT) -- Requirements for quality

International Organization for Standardization (ISO)

Clinical laboratory testing and in vitro diagnostic test

ISO 22870:2006 gives specific requirements

Patient self-testing in a home or community setting is

Point-of-Care Connectivity; Approved Standard- Second

Clinical and Laboratory Standards Institute

Lab Information Systems, Auto Analysis

This standard provides the framework for engineers to

Implementation Guide of POCT1 for Healthcare Providers;

Clinical and Laboratory Standards Institute

Lab Information Systems, Auto Analysis

This document identifies and describes the particular

Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved

Clinical and Laboratory Standards Institute

In vitro diagnostic (IVD) devices outside the clinical

This document provides guidance to users of in vitro

Wellness Testing Using IVD Devices; Approved Guideline

Clinical and Laboratory Standards Institute

Wellness Testing Using IVD Devices

Wellness Testing Using IVD Devices; Approved Guideline

Glucose Monitoring in Settings Without Laboratory

Clinical and Laboratory Standards Institute

Glucose test system

Clinical and Laboratory Standards Institute document

Laboratory Automation: Specimen Container/Specimen

Clinical and Laboratory Standards Institute

ALL CONTAINERS, SPECIMEN TRANSPORT

This document provides standards for the design and

Laboratory Automation: Bar Codes for Specimen Container

Clinical and Laboratory Standards Institute

Auto Analyses, Reagent Containers

This document provides specifications for use of linear bar

Laboratory Automation: Electromechanical Interfaces;

Clinical and Laboratory Standards Institute

Lab Information Systems, Auto Analysis

This document provides standards for the development of

Laboratory Automation: Data Content for Specimen

Clinical and Laboratory Standards Institute

Lab Information Systems, Auto Analysis

This document provides specifications for the content of

Protocols to Validate Laboratory Information Systems;

Clinical and Laboratory Standards Institute

Laboratory Information Systems

This document provides guidance for developing a protocol

Remote Access to Clinical Laboratory Diagnostic Devices

Clinical and Laboratory Standards Institute

Laboratory information system

This document provides guidance for developing a protocol

Preparation and Validation of Commutable Frozen Human

Clinical and Laboratory Standards Institute

IN VITRO DIAGNOSTIC DEVICES FOR THE

Analytical Procedures for the Determination of Lead in

Clinical and Laboratory Standards Institute

A device intended to measure lead, a heavy metal, in blood

This document provides guidelines for the measurement of

Evaluation of the Linearity of Quantitative Measurement

Clinical and Laboratory Standards Institute

IVD medical devices.