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IEC 60601
The 3rd Edition
Overview of update
New technology is entering the market at a aster pace than ever
beore. Medical device technology is no exception. Like consumer
electronics and other technologies that enter the consumer market,
there is a need to get sae medical devices to market aster.
Standards have kept up with the globalization o medical devices,
such that many o the recognized standards or medical devices
are internationally harmonized, with national deviations as needed
or local language and power grid requirements. Where there have
been challenges is in providing exibility or the introduction o
new technologies to the market. This is one o the primary benefts
o the 3rd Edition o the IEC 60601.
The 3rd Edition, which is in the process o being adopted by countries
and public health organizations globally, takes away the limitationso the 2nd Edition. It applies to a broader range o products and has
been revised to acilitate technological advancement and establish
the oundation or a dierent approach to standards conormity
assessment. Issued in 2005, one o the most signifcant changes to
the 3rd Edition is the requirement or manuacturers to demonstrate
the use o risk management during product development and also
ater the product is in the marketplace.
Although it will require a transition, with the incorporation o risk
management requirements in the 3rd Edition, companies have the
opportunity to introduce new technologies and develop devices
that do not ft into the test limits and parameters o the 2nd Editiono IEC 60601. Currently, i a manuacturer submitted a device that
didnt ft within the 2nd Edition, such as a dental device that exceeds
patient applied parts limits, the manuacturer would have to apply
or an exception, thereby delaying testing and extending the time to
market or the device.
While the shit in standard methodology to include risk manageme
has been a major point o discussion among the certifcation bodies,
assessing and understanding risk is a well-established concept
within the medical device industry. This is because medical device
are critical to public health and saety. They are regulated by the
country or economic area (such as the EU) to ensure each device
is sae and eective or its intended use. Not only do regulators
look at saety to the operator, but also eectiveness in providing
a diagnosis, treatment, therapy and/or physiological unction to a
patient. As such, regulators have to look at both the product and
the process by which medical devices are manuactured to ensure
adequate controls are in place to ensure quality in manuacturing,
post market surveillance and acceptable levels o risk.
When medical device manuacturers apply or market approval,
they oten are required to submit their technical fle documentation
to the regulator. This fle includes test reports or electrical saety,
biocompatibility, usability, unctional saety, electromagnetic
compatibility, instructions or use, packaging, shipping requirements,
clinical test data, etc.
While there has been slow movement in adoption o the 3rd Editio
there is indication that more government bodies will begin requirin
conormity. In late 2009, Health Canada and the European Union
announced devices must demonstrate conormity to the 3rd Editio
by June 2012. As o 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.
INDUSTRY REPORT ON: THE FUTURE OF GLOBAL
CERTIFICATION FOR MEDICAL DEVICES
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Manuacturers must make decisions on what standard to design t
depending on the market(s) they will enter, the timing o their mark
entry, and their products lie cycle. As a leader in saety certifcatio
and standards development, UL is committed to keeping the indus
inormed o the status o the major medical regulatory markets, in ord
to acilitate market access or our customers around the world.
Table 1: Status of collateral standards in 3rd edition
60601-1-1 Safety Requirements Included in general
for Medical Electrical standard IEC 60601-1
Systems
60601-1-4 Programmable Included in general
Medical Electrical standard IEC 60601-1
Systems
60601-1-10 Closed Loop Published as collateral
Therapeutic
Controllers
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
60601-1-9 Requirements for Published as
Environmentally collateral, but will not
Conscious Design be harmonized with
the MDD or AIM
60601-1-11 Home Healthcare Published as collateralProducts
60601-1-2 EMC Published as collateral
Collateral standard Name Status in 3rdedition
60601-1-3 Radiation Published as collateral
60601-1-8 Alarm Systems Published as collateral
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