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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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