Tag: medical

FDA Adds 4th edition of IEC 60601-1-2 to EMC Consensus Standards List

by on Jan.12, 2015, under EMC, Medical

In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems.

The complete standard is recognized with the following exception:

In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced by RF fields” (4th Row) is not recognized.

Starting on April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007 or ANSI/AAMI/IEC 60601-1-2:2007.  This recognition affects all electrical medical devices, except for active implanted devices.

However, a new FDA publication “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now (not 2017!) to cover test levels which may not be properly addressed in the 3rd edition.

Some of the changes to the 4th edition from the 3rd edition of IEC 60601-1-2 are:

  • With regards to electromagnetic environments, the “life supporting equipment” category has been removed
  • CISPR 15 has been removed as an option for lighting features, replaced by CISPR 11
  • ESD test levels were increased for both air and contact type discharges
  • RF susceptibility test levels are now specified based on the intended use environment
  • Transient tests on DC input power ports in accordance with ISO 7637-2 have been added
  • New conducted RF disturbances requirements are based on location of intended use
  • Test levels for power frequency magnetic fields increased tenfold, to 30 A/m
  • Testing is now at multiple phase angles for the half-cycle, 100% voltage dip

There are many other changes in the 4th edition, contact MET Labs to schedule a new product discovery or existing product ‘gap analysis.’

MET is a leading independent test lab for medical equipment approvals for product safety, EMC and performance.  Learn more about Medical Compliance Testing.

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Health Canada Provides Guidance on IEC 60601-1 3rd Edition Transition

by on May.07, 2012, under Canada, Medical, Product Safety

For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.

New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.

To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards.  It states:

  • If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
  • If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
  • If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.

These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.

Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.

The Health Canada website should be consulted for the most current List of Recognized Standards.

For the 3rd edition implementation schedule for the United States, see this Compliance Today post.

Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.

For testing and certification to the second or third edition of 60601-1, contact MET Labs.

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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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Medical Product Safety Training Yields Insight on IEC 60601-1 3rd Edition

by on Mar.25, 2011, under Medical, Product Safety

MET Laboratories’ product safety engineers undergo regular training to stay up-to-date with changing standards and regulatory requirements.  When possible, we will share highlights of these sessions with customers.

Following are some of the key points of a recent training session on IEC 60601-1 3rd edition:

  • It is an entirely new standard and does not match up with the second edition. The effort required by manufacturers and test labs has at least doubled, or tripled for particularly complex products.
  • Risk Management is an integral part of the new standard. This will catch many manufacturers by surprise.
  • The new standard references ISO 14971, Risk Management, and requires traceability for each identified hazard for the risk analysis, evaluation, implementation and verification of risk control measures and the acceptable risk.
  • The risk management process for applied parts and parts that may contact the patient but that are not applied parts, is particularly onerous.
  • The new standard mandates use of collateral standards in addition to particular, or Part 2, standards. This is likely to catch manufacturers by surprise too.
  • The Risk Management file that a manufacturer must develop has to address the expected service life of the product.
  • The effective date for the EU and Canadian versions is June 2012.
  • The FDA will accept it now but will also continue to accept the previous edition until June 2013.
  • OSHA has not made a decision to recognize the standard yet. They are polling NRTLs as part of their research into this new standard. To meet OSHA workplace rules, medical products may only be certified by an NRTL to the current edition of the UL standard.
  • Though there has been a phase-in period for the main EU standard, collaterals and part 2s are effective upon their publication dates.
  • Some new collaterals are or have been introduced. For example, included now is IEC 60601-1-9, Environmentally Conscious Design.
  • Some previous collaterals, like 60601-1-1 for systems of equipment and 60601-1-4 for EMC, have been incorporated into the base standard now.

See our recent blog post for more information on the various rates of adoption of 60601-1 3rd edition in different countries and regions. 

Also, find out more about EMC and Performance Testing of medical products.

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IEC 60601-1 3rd Edition Challenges Medical Products Industry

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

Rarely has a standard change elicited as much confusion – and anguish – as the transition to the third edition of 60601-1. 

Much of the confusion surrounds the varying rates of adoption of the new edition in different countries and regions.  Here is a basic primer: 

IECEE CB Scheme – Issued in 2005, IEC 60601-1 3rd edition is effective now, but so is the 2nd edition, which is still acceptable in many markets.  It’s usually up to the user/buyer/distributor to determine what level of certification he wants.

European Union – EN 60601-1 3rd edition is effective June 1, 2012, but can be used now.  Some part 2 standards may have an earlier adoption date and thus require use of the 3rd edition before June 1, 2012.

Canada – CSA C22.2 NO. 60601-1-08 is effective June 1, 2012, but can be used now.  Health Canada will continue to accept declarations of conformity to the second edition of IEC 60601-1 until June, 2012.  After June, 2012 Health Canada intends to only accept declarations to the third edition of IEC 60601-1, and the related collateral and particular standards.

United States – UL has published AAMI ES 60601-1, Ed. 1.  Acceptance of this standard or the previous edition is up to the user/buyer/distributor.  Though it may be used now it’s not OSHA-recognized yet, so NRTL certification must still be to UL 60601-1 2nd edition.  The FDA does recognize AAMI ES 60601-1: 2005, but will continue to accept declarations of conformity to IEC 60601 2nd edition until June 30, 2013.

The anguish surrounding the third edition is attributable to the much stiffer requirements of the standard.  Most significantly, the 3rd edition requires that the manufacturer establish a risk management file and process as outlined in ISO 14971, the international standard for Application of Risk Management to Medical Devices.

Because of these new requirements, third edition certification projects are typically double to triple the duration and cost of their second edition equivalent.

More on medical product certification to IEC 60601-1.

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Safety Certification to UL/IEC 61010-1 Evolves

by on Feb.04, 2011, under Product Safety

Product safety certification for healthcare & other laboratory equipment continues to evolve.  Thirteen months ago, on January 1, 2010, all new products and alternate constructions of listed or recognized products were required to be evaluated to UL 61010-1 2nd Edition.

The Second Edition combines UL 61010A-1 for laboratory equipment, UL 61010B-1 for test and measurement equipment and UL 61010C-1 for process control equipment into a single standard.

On January 1, 2014, UL 61010A-1, UL 61010B-1 & UL 61010C-1 will be withdrawn, and all listed and recognized products must comply with UL 61010-1 2nd Edition.

Europe is on a different schedule.  October 1, 2013 is the EU date of cessation for IEC 61010-1 2nd Edition.  (IEC 61010-1 2nd Edition is aligned with UL 61010-1 2nd Edition, except for some U.S. national differences in the UL edition.)

IEC published the Third Edition of 61010-1 in June 2010. See the abstract here.  Some of the major changes to the new edition include:

  • Scope now covers both professional and non-professional products
  • Test and measurement circuit requirements separated into a Part 2 standard: IEC 61010-2-30
  • Reworked Clause 6.7 and added Annex K for clearances, creepages, solid and thin film insulation and molded and potted parts
  • Temperature requirements modified due to EN563
  • X-ray requirements modified to include intended and non-intended emissions
  • New requirements for conformal coatings
  • New requirements for risk assessment
  • Added requirements for foreseeable misuse and ergonomics

The United States Technical Advisory Group (US TAG) and harmonization committee is working on the North American harmonized standards to IEC 61010-1 3rd Edition.  They are completing the National Differences and plan to have the standard developed and issued by the Spring of 2012.

More on certification to UL/IEC 61010 & medical product certification to UL/IEC 60601.

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