INDUSTRY REPORT ON: THE FUTURE OF GLOBAL
CERTIFICATION FOR MEDICAL DEVICES
IEC 60601
The 3rd Edition
Overview of update
New technology is entering the market at a faster pace than ever
before. Medical device technology is no exception. Like consumer
electronics and other technologies that enter the consumer market,
there is a need to get safe medical devices to market faster.
Standards have kept up with the globalization of medical devices,
such that many of the recognized standards for medical devices
are internationally harmonized, with national deviations as needed
for local language and power grid requirements. Where there have
been challenges is in providing flexibility for the introduction of
new technologies to the market. This is one of the primary benefits
of the 3rd Edition of the IEC 60601.
The 3rd Edition, which is in the process of being adopted by countries
and public health organizations globally, takes away the limitations
of the 2nd Edition. It applies to a broader range of products and has
been revised to facilitate technological advancement and establish
the foundation for a different approach to standards conformity
assessment. Issued in 2005, one of the most significant changes to
the 3rd Edition is the requirement for manufacturers to demonstrate
the use of risk management during product development and also
after the product is in the marketplace.
Although it will require a transition, with the incorporation of risk
management requirements in the 3rd Edition, companies have the
opportunity to introduce new technologies and develop devices
that do not fit into the test limits and parameters of the 2nd Edition
of IEC 60601. Currently, if a manufacturer submitted a device that
didn’t fit within the 2nd Edition, such as a dental device that exceeds
patient applied parts limits, the manufacturer would have to apply
for an exception, thereby delaying testing and extending the time to
market for the device.
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While the shift in standard methodology to include risk management
has been a major point of discussion among the certification bodies,
assessing and understanding risk is a well-established concept
within the medical device industry. This is because medical devices
are critical to public health and safety. They are regulated by the
country or economic area (such as the EU) to ensure each device
is safe and effective for its intended use. Not only do regulators
look at safety to the operator, but also effectiveness in providing
a diagnosis, treatment, therapy and/or physiological function to a
patient. As such, regulators have to look at both the product and
the process by which medical devices are manufactured to ensure
adequate controls are in place to ensure quality in manufacturing,
post market surveillance and acceptable levels of risk.
When medical device manufacturers apply for market approval,
they often are required to submit their technical file documentation
to the regulator. This file includes test reports for electrical safety,
biocompatibility, usability, functional safety, electromagnetic
compatibility, instructions for use, packaging, shipping requirements,
clinical test data, etc.
While there has been slow movement in adoption of the 3rd Edition,
there is indication that more government bodies will begin requiring
conformity. In late 2009, Health Canada and the European Union
announced devices must demonstrate conformity to the 3rd Edition
by June 2012. As of April 2010, FDA has hinted that it will recognize
the 3rd Edition, while Japan, the third largest market in the world,
has remained non-committal.
Table 1: Status of collateral standards in 3rd edition

Collateral standard Name Status in 3rd edition
60601-1-1 Safety Requirements Included in general
for Medical Electrical standard — IEC 60601-1
Systems
60601-1-2 EMC Published as collateral
60601-1-3 Radiation Published as collateral
Manufacturers must make decisions on what standard to design to,
depending on the market(s) they will enter, the timing of their market
entry, and their product’s life cycle. As a leader in safety certifications
and standards development, UL is committed to keeping the industry
informed of the status of the major medical regulatory markets, in order
to facilitate market access for our customers around the world.

60601-1-4 Programmable Included in general

Medical Electrical standard — IEC 60601-1
Systems

60601-1-5 Image Quality and Withdrawn

Dose for X-ray
Equipment

60601-1-6 Usability Will be replaced

by IEC 62366, IEC
60101-1-6 converted
to a TR or guidance
document

60601-1-8 Alarm Systems Published as collateral

60601-1-9 Requirements for Published as

Environmentally collateral, but will not
Conscious Design be harmonized with
the MDD or AIM

60601-1-10 Closed Loop Published as collateral

Therapeutic
Controllers

60601-1-11 Home Healthcare Published as collateral

Products

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