Standards for Reprocessing Processes (1)

Washing Chemical Biological

Validation Sterilizers Packaging
Disinfection Indicators Indicators
EN ISO 14937 EN 285 EN 867-5 EN ISO 11138-1 EN ISO 11607-1
Requirements for Requirements for large EN ISO 15883-1
Chemical indicator General requirements Packaging of medical
development, validation sterilizers (over 54 l) General Requirements
systems for steam and classifications on devices
and routine monitoring of for washer/disinfectors
EN 13060 sterilizers (Test standard Biological indicators (BI)
all sterilization processes Requirements for small for hollow load test) EN ISO 11607-2
EN ISO 11135 sterilizers (below 54 l) EN ISO 15883-2 EN ISO 11138-2 Validation requirements
EO processes W/D requirements for EN ISO 11140-1 BI for EO sterilization
EN 14180 surgical instruments
for forming processes
EN ISO 11137-1 -3 Requirements for General requirements,
EN ISO 11138-3 DIN CEN ISO/TS 16775
Radiation processes LTSF sterilizers definition and test
EN ISO 15883-3 BI for steam sterilization Guidance for the
EN 1422 procedure for chemical
DIN CEN ISO/TS 13004 W/D requirements for application of
Requirements for indicators (CI) EN ISO 11138-4
Radiation processes containers for human EN ISO 11607-1+2
EO sterilizers waste BI for dry heat sterilization
EN ISO 17665-1 -3 EN ISO 18472 EN ISO 11140-3 EN 868 Series 2-10
EN ISO 11138-5
Steam processes Requirements for EN ISO 15883-4 Requirements for the Packaging of sterile
BI for LTSF sterilization
test sterilizers original BD-test page goods
W/D requirements for
EN ISO 25424 (resistometers) themolabile endoscopes EN ISO/WD 11138-6
LTSF processes EN ISO 11140-4 BI for H2O2 sterilization
prEN 17180 Test requirements for BD- processes
Sterilizer for H2O2 ISO/TS 15883-5 Simulation tests
EN ISO 14937 W/Ds – test soils and
also for H2O2/ Plasma sterilization processes EN ISO/CD 11138-7
methods (old ISO 14161)
processes, since no EN 12347 ISO 11140-5
special standard available Test requirements for the Guidance for the
Biotechnology - EN ISO 15883-6 selection, use and
US BD-test
EN ISO 20857 Performance criteria for W/Ds – Requirements interpretation of the results
steam sterilizers and and tests for general for biological indicators
Dry heat processes ISO/WD 11140-6
autoclaves purpose W/Ds with Type 2 indicators and
EN ISO 17664 thermal disinfection EN ISO/CD 11138-8
PCDs as sterilizer tests
Information about Biological indicators –
prEN ISO 15883-7 Reduced Incubation Time
reprocessing of re-usable EN ISO 15882
W/Ds – Requirements (RIT)
medical devices Guidance for the
and tests for general
purpose W/Ds with selection, use and
DIN 58921 interpretation of the results
chemical disinfection for
Validation of medical for chemical indicators
bedframes, containers,
device simulators (MDS)
etc.
(English version available)
EN 16442 European Medical
EN 556-1 Storage cabinet for red = new Device Regulation
Definition: endoscopes
(MDR) 2017/745
Sterility Assurance Level

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 Standards for Reprocessing Processes (2)
Pharmaceutical Sterilizing Disinfectants Aseptical
Additional standards
Procedures agents and disinfectors Production

DIN 58950-1 EN ISO 14160 EN 1499 EN ISO 13408-1 EN 980 ISO/TS 11139
Liquid chemical Hygienic cleaning Symbols for labeling Terms and definitions in
Definitions General Requirements
sterilizing agents for of hands of medical devices sterilization standards
medical devices
EN 1041 EN ISO
DIN 58950-2 EN 1500 EN ISO 13408-2
Information supplied by
Technical requirements Hygienic hand Filtration 11737-1, -2
the manufacturer of
disinfection Microbiological
medical device
methods
DIN 58950-3 DIN 12353 EN ISO 13408-3
EN 15224
Tests Preservation of test Lyophilization
Healthcare services
EN ISO 14971
organisms Risk management of
EN ISO 13408-4 EN ISO 13485 medical devices
DIN 58950-6 EN 14476 Medical device quality
Clean-in-place
Operation
Virucidal quantitative management system EN 15986
technologies
Symbols to mark
suspension test for EN ISO 15223-1
DIN 58950-7 medical devices
chemical disinfectants EN ISO 13408-5 Symbols for labeling
Requirements on and antiseptics Sterilization in place of medical devices DIN 58953-1
services and local Sterile supply –
environment DIN 58949 EN ISO 10993-1 -17 Terminology, Logistics
Steam disinfection EN ISO 13408-6 Classification of
apparatus Isolator systems medical devices
DIN 58953-6
RKI1 list of tested EN 61010-1 Test of microbial barrier
General safety of packaging material
disinfectants and
requirements for
Surgical drapes disinfection
sterilizers and WDs
processes DIN 58953-7
Application technology
EN ISO 61010-2
EN 13795 VAH2 list of packaging material
Particular safety
Surgical drapes, gowns
disinfectants requirements for
DIN 58953-8
and clean air suits
sterilizers and WDs
General requirements Logistic of sterile MD
EN ISO 12100
Safety of machinery – DIN 58953-9
risk assessment Application technology
1 sterilization containers
RKI = Robert Koch Institute, Germany EN 61326-1
2 VAH = Association for applied hygiene, Germany EMC requirements for E DIN 13942
laboratory equipment Dentistry –
Reprocessing

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