Archive for October, 2011

60601-1 Third Edition Overview Covers Key Changes from Second Edition

by on Oct.24, 2011, under Medical, Product Safety

This Compliance Today blog post is derived from the second half of a MET Labs-hosted 60601-1 3rd Edition Overview webinar.  Find the transcription of the first half of the webinar here, or the full recorded webinar here.

Following are the key changes from the 2nd to 3rd edition of 60601-1 for electro-medical device product safety certification.

Risk Management File
The Risk Management File is a new requirement for 3rd edition that goes beyond electric shock, energy and fire hazards.  It requires consideration of all possible risks of use.  The manufacturer must have a policy that addresses risks to include:

  • A declaration of acceptable risks
  • A declaration of acceptance of residual risks

ISO 14971 is essential to a successful Risk Management File. The certification body shall review the Risk Management File and verify that the manufacturer has:

  • Established a suitable process to manage risks of the particular product
  • Established reasonable acceptance levels for these risks
  • Shown that residual risks are acceptable

The Risk Management File must be submitted when a product is submitted to the certification body.

Essential Performance
Essential performance is not new but has been enhanced for third edition.  Many Part 2s have been rewritten with increased performance requirements.  Manufacture must define for their device even if Part 2 does not exist.  Manufactures must address essential performance in the Risk Management File.

Markings & Documentation
Markings must be clearly visible under defined angle, distance and lighting parameters.  Visibility is based on essentially perfect human sight (20/20 in U.S.).

Third edition also has new international symbols or meanings of previous symbols.  There is also increased documentation information.

Usability is addressed in IEC 60601-1-6.  It covers design, controls, signals, and instructions, and needs to be addressed in the Risk Management File.

Transport and storage conditions must be indicated, including any special instructions.  The use of symbols per ISO 780 is mandated.

Insulation Coordination
Changes allow for more compact and less costly designs.  However, they are more complex to interpret.

Hand & Foot Controls
Third edition specifies: 

  • Isolation from hazardous voltages
  • Activation tests
  • Cord anchorage and guard same as mains cord requirement
  • Ingress IPX1 and IPX6

Other Differences
Following are other key difference areas:

  • Stability and mobility tests
  • Noise and vibration tests
  • Temperatures on accessible parts (other than applied parts)
  • Temperatures on applied parts
  • Fire enclosure
  • Mechanical strength
  • Radiation hazards
  • Software
  • EMC

Find out more about product safety testing and certification of electrical medical equipment, or the new Program for Testing Medical Devices for Susceptibility to RFID.

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60601-1 Third Edition Overview Outlines Adoption in U.S., Canada & EU

by on Oct.21, 2011, under Medical, Product Safety

Last week, MET Labs hosted a 60601-1 Third Edition Overview webinar.  The webinar was very popular, so we are following up with a transcription of many of the key points.

About half of the presentation was devoted to regional acceptance.

United States
In the U.S., the current standard is UL 60601-1 First Edition, with revisions through April 26, 2006.

  • Based on IEC 60601-1 Second Edition with Amendment 1 and Amendment 2
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are optional

AAMI ES60601-1:2005 incorporates Amendment 2: 2010

  • Based on IEC 60601-1 3rd Edition
  • FDA will accept now as well as previous version
  • FDA has stated they will mandate acceptance by July 1, 2013
  • OSHA has not yet recognized this edition

OSHA, which governs the NRTL program, is concerned with the new concepts of risk-based hazard analysis and the Risk Management File.  It does not yet recognize it nor endorse certification bodies to certify to it.  It may be prudent to consider obtaining current edition and 3rd edition certification.

In Canada, the current standard is CSA C22.2 601.1-M90 First Edition, revised through November 2003.

  • Based on IEC 60601-1 Second Edition
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are required

Canada also recognizes CSA C22.2 No. 60601-1-08, which is based on the Third Edition.

Switchover date from 2nd edition to 3rd edition is June 2012.

European Union
In Europe, the current standard is EN 60601-1, with amendments through January 1996.

  • Based on IEC 60601-1 Second Edition
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are required

EU also recognizes EN 60601-1, incorporating corrigendum March 2010, which is based on IEC 60601-1 Third Edition.

Switchover date from 2nd edition to 3rd edition is June 2012.

CB Scheme
For the CB Scheme, the current standard is IEC 60601-1 Second Edition, with amendment 1.

  • Requires use of Particular Standards or Part 2s
  • Collateral standards may be required

CB Scheme also recognizes IEC 60601-1 Third Edition.  Participating countries determine which edition they accept.

Stay tuned.  Next week we will cover the other half of the webinar: Key changes in the 3rd edition of 60601-1.

Find out more about product safety testing and certification of electrical medical equipment.

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IEC 62368-1 Gains Prominence as Eventual Replacement for IEC 60950-1 & IEC 60065

by on Oct.05, 2011, under Product Safety

As the weeks and months march on, IEC 62368-1 elicits more chatter.  Designed to replace IEC 60950-1 2nd edition (IT equipment) and IEC 60065 7th edition (A/V equipment), the new product safety standard is not a merging of these two standards.

As new devices and applications emerge at an unprecedented rate, and technologies continue to converge, 60950-1 and 60065 have had to undergo numerous modifications, making them more complex and difficult to use.  IEC 62368-1 is designed for long-term stability and relevancy, regardless of product advancements.

Nearly ten years in development, 62368-1 covers a broad range of products, and allows for the minimalizing of national or regional differences.  Technology-neutral and performance – not prescriptive – based, the new standard is expected to help engineers integrate safety compliance early in the product design cycle and help manufacturers speed time to market. 

IEC 62368-1 Ed 1.0: Audio/Video, Information and Communication Technology Equipment — Safety Requirements is based on the principles of Hazard-Based Safety Engineering (HBSE).  Like the major risk-based change with IEC 60601-1 for electro-medical equipment, HBSE represents a paradigm shift for audio-visual, communication, and information technology products.

HBSE is a process that utilizes a three-block model to address the transfer of hazardous energy to a body part.  It describes methods to mitigate hazards and measure safeguard effectiveness.

IEC 62368-1 also has some new requirements to enhance product safety, including:

  • Methods for classifying energy sources
  • Definitions for ordinary persons, instructed persons, and skilled persons
  • Child accessibility test probe

Edition 1.0 of IEC 62368-1 was published as an international standard on January 10, 2010, with a minimum five year effective date recommended by IEC Technical Committee (TC) 108.  The second edition is planned to be published in 2013.  Final implementation of IEC 62368-1 second edition is likely sometime between 2015 and 2018. There will be a transition period where 60950-x, 60065, and 62368 will all need to be maintained.

See other product safety-related blog posts.

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