60601 Medical Blog

• September 2012 - What is going on with 60601 3rd Edition now that June 1st 2012 has passed?

  Now that the European Union effective date of June 1, 2012 for the 3^rd Edition of IEC 60601-1 has come and gone, many of our customers have asked, "What's next?"  Here we provide a brief update on some of the developments on both the Regulatory and Standards front.

  Regulatory:

  European Union Notified Bodies:

  It must first be understood that the June 1, 2012 was only applicable to devices not covered by an associated "Part 2" Particular Standard.  That is, the effective dates (aka DOCOPOCOSS - Date of Cessation of Presumption of Conformity of the Superseded Standard) in the European Union are based off of the dates of publication of the EN (European Norm) version of the Part 2 Standard that is applicable to a given device.  For example, EN 60601-2-37, Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, was published on November 27, 2008, and the DOCOPOCOSS was set for October 1, 2010.  Therefore devices covered by EN 60601-2-37 needed to comply with the combination of EN 60601-1:2006 and EN 60601-2-37:2008 by October 1, 2010 rather than June 1, 2012.  So to determine compliance needs for the European Union, it is critical to understand whether there is an applicable Part 2 for your device, and then determine the DOCOPOCOSS for that Part 2.

  That is, the DOCOPOCOSS for the part 2 standards supersede that of the general standard, so if your device falls under the scope of a published part 2 standard (3^rd edition compatible), then the latest date of the DOCOPOCOSS is the one that will apply.  If you do not have a part 2 standard that applies, or similarly if the applicable part 2 standard(s) is(are) not yet published, the DOCOPOCOSS of the general standard applies.  The list of harmonized standards and the corresponding DOCOPOCOSS can be found on the Europe website.

  US

  There are two key regulators that must be considered for devices to be placed on the market in the United States; the FDA and OSHA.

  With respect to the FDA, medical device manufacturers who want to market and sell their devices in the United States can continue to meet FDA requirements with a test report that shows conformity to UL 60601-1 (the 2^nd Edition) until June 30, 2013.  Based on past FDA practice, after June 30, 2013, there is no need to provide a new 510(k) submission according to the 3^rd Edition for devices, which are already on the US market (tested according to the 2^nd Edition) assuming that no significant changes have been made to the product.  We have yet to see formal guidance issued by the FDA concerning their expectations for the 3^rd Edition.

  OSHA has been relatively silent regarding the 3^rd Edition.  Their website listing "recognized" standards still only shows UL 60601 (the 2^nd Edition) as the standard applicable to Medical devices.  We understand that there have been discussions between OSHA and FDA staff concerning the 3^rd Edition, but a formal position is still yet to be announced.

  Canada

  In Canada, Health Canada established the following Transition Rules applied as of June 1, 2012 for manufacturers who submit medical device license applications for devices that rely on conformity with IEC 60601 to demonstrate safety and effectiveness.

  If there is not a particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 (3^rd Edition) and its applicable collateral standards.

  • If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1:2005 was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1:2005 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: 2005 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 (and both will be listed on Health Canada's List of Recognized Standards).

  There are several important notes to these implementation dates that manufacturers should consider, including:

  Although collateral standard IEC 60601-1-9, "Requirements for environmentally conscious design" is a normative reference of IEC 60601-1:2005, the Medical Devices Regulations apply only to safety, effectiveness and quality of devices; therefore, Health Canada recommends that manufacturers design their devices in an environmentally conscious manner, but compliance with this collateral standard is not a requirement for licensure.

  • The Canadian Electrical Code is separate and distinct from the Medical Devices Regulations and is mandated by Provincial and Territorial electrical safety authorities, not by Health Canada. Therefore, in addition to having a medical device license, mains-powered electromedical devices sold in Canada must be "approved" under the Canadian Electrical Code, and must bear a mark of conformity recognized by the Provincial and Territorial electrical safety authorities.

  As always, it is recommended that you directly contact your regulatory authority for implementation details applicable to your specific devices.

  Standards:

  As part of the normal standards development process, after the standard was published, National committees and other interested parties identified issues that were documented for action. Ultimately there were a total of 182 identified issues, which included:

  • the way in which risk management was introduced into the standard, and
  • the way the concept of essential performance is used in the standard.

  As a result, Amendment 1 to IEC 60601-1:2005 was drafted to address the issues, and was published by the IEC in July of 2012.  We expect AAMI will issue a version of Amendment 1 in the near future for the US, which will be presented as a combined document (body of the General Standard and Amendment 1 merged).  For Europe, the EN version has yet to be issued; however perhaps more importantly, it should be recognized that there has been recent controversy in Europe related to the Annex Z's in the standards.  As background information, the Annex Z's (which are Informative) in the European standards declare the extent to which a standard is harmonized with the individual Essential Requirements of an applicable Directive.  Since harmonization of a standard provides a "presumption of conformity" to the legal market entry requirements for a device (the Directives), this is critical.

  In the past many EN standards were written with blanket statements in a given Annex Z stating they were harmonized.  However recent official objections from member states and the European Commission have led to some of these standards having more precise Annex Z's written to directly correlate the harmonization of specific clauses to specific Essential Requirements.  Notably, EN ISO 13485:2012 and EN 14971:2012 have been published with specific Annex Z's (for example, EN 14971:2012 contains Annex ZA relates to the Medical Devices Directive 93/42/EEC, Annex ZB relates to the Active Implantable Devices Directive 90/385/EEC and Annex ZC relates to the In-vitro Diagnostics Devices Directive 98/79/EC).  Manufacturers should be aware of recent publications of these standards and their DOCOPOCOSS to ensure that they only claim the legal presumption of conformity with what is permissible in the Annex Z, and that they have taken appropriate steps to fully support all elements of the applicable Directives.  

  Please note however that use of standards in declaring compliance to the Essential Requirements are entirely voluntary and are only one option for demonstrating conformity.  That is, harmonized standards do provide a presumption of conformity when used in accordance with the applicable Annex Z, but Manufacturers may use other methods to demonstrate conformity with the Essential Requirements.  If you have any questions regarding specific expectations related to your products, we strongly encourage contacting your Notified Body.

  Highlights of Amendment 1 include many clarifications of requirements to the Standard, and also some changes in requirements.  Some of the notable items include (Note this is not a complete list of the Amendment 1 content):

  Essential Performance - Clause 4.3 on Essential Performance in the standard has been greatly expanded content-wise, and specifies that

  • Clinical performance of the device, beyond basic safety, is to be identified
  • Performance limits, ranging from full functionality to total performance loss in both normal and single-fault conditions, is to be specified
  • If resulting risks are unacceptable risk controls to be introduced to reduce to an acceptable level

  Threshold Test - Subclause 9.4.2.4.3, the threshold test for transportability, was revised.  Significantly, the threshold height of 20 mm that had been specified for the test was reduced to a height of 10 mm.   Another change to the test specification was that the speed of the wheels or castors impacting the obstruction was increased from 0,4 m/s  to 0,8 m/s.  

  Y1 Capacitors - Subclause 8.5.1.2 and 8.5.1.3 were revised.  Specifically, the requirements allowing use of Y capacitors as a means of protection were substantially revised to clarify when Y1 or Y2 capacitors can be used as either a means of patient or operator protection.  Notably, where the working voltage involved are less than 42,4 V peak a.c. or 60 V d.c., a single Y1 capacitor is now acceptable for two means of patient protection.

  Software - Subclause 14.1 was revised such that, when the requirements in subclauses 14.2 to 14.13 apply, the requirements in subclause 4.3, Clause 5, Clause 7, Clause 8 and Clause 9 of IEC 62304:2006 must be applied to the development or modification of software for each PESS.

  Transformer - Subclause 15.5.3 covers construction of transformers used to provide separation as required by 8.5.  Initially the 3rd edition required transformers to comply with IEC 61558 to harmonize transformer requirement similar to other major Standards.  However in practice, it was determined that, due to the need of the transformers to provide spacings and dielectric properties meeting the MEANS OF PATIENT PROTECTION requirements, an IEC 61558 transformer was typically not suitable for the application. Consequently, Amendment1 reverted to the transformer requirement as specified in IEC60601-1, 2nd edition.

  Batteries - Subclause 15.4.3.4 Lithium Batteries.  This subclause was revised to require primary and secondary lithium batteries to comply with IEC 60086-4 and IEC 62133 respectively.  It should also be noted that the IECEE issued a CMC decision (Certification Management Committee of the CB Scheme) requiring all secondary batteries to comply with IEC62133 - additional details can be found on the UL website at: http://www.ul.com/global/eng/pages/offerings/industries/hightech/batteries/iec62133/cmc3/       

  Please note that UL has testing capabilities for all types of batteries and will assist client request for testing to IEC 62133 alone or in addition to UL 1642 & UL 2054 Certifications.

  Additional questions?  There are many other changes introduced by Amendment 1, and we encourage our customers to review the Amendment and discuss any questions with their UL engineer.

• August 2012 - C-UL Classification of 60601 2nd edition products past July 2014

  There is a difference between expectations amongst Regulators, sometimes even within the same country.  For example, in the US, we have the FDA looking for 60601 3^rd Edition compliance (new and significant changes to existing devices) in 2013, whereas OSHA, under their NRTL program, has yet to recognize the 3^rd Edition.  This means that it is entirely possible that devices marketed in the US in the future may need to be compliant with both editions of the Standard for some period of time.  It is possible that we have the same situation in Canada. 

  Health Canada updated their web page on August 15 of 2012 to include "Additional Guidance Relating to Transition."  Some key points include:

  • "If the transition rules above dictate that compliance with the 3rd edition is required for a Declaration of Conformity and you wish to declare conformity to the 2nd edition, applications must be shipped before June 1, 2012.......
  • A Medical Device Licence is issued by Health Canada when acceptable evidence has been provided to show that the device meets the requirements of the Medical Devices Regulations. However, manufacturers are reminded that the Canadian Electrical Code is separate and distinct from the Medical Devices Regulations and is mandated by Provincial and Territorial electrical safety authorities, not by Health Canada. Therefore, in addition to having a medical device licence, mains-powered electromedical devices sold in Canada must be "approved" under the Canadian Electrical Code, and must bear a mark of conformity recognised by the Provincial and Territorial electrical safety authorities. For further information regarding these requirements, contact the applicable regulatory authorities.
  • Other Provincial, Territorial or municipal regulations may also apply to certain types of medical devices."

  Health Canada is the Regulatory Agency responsible for market entry of medical devices in Canada; therefore, this notice remains in effect.  That is, for regulatory approvals by Health Canada, medical devices intended for sale in Canada must comply with the 3^rd Edition.  Health Canada notes, however, that manufacturers must also consider and comply with applicable Provincial and Territorial electrical safety authorities.  

  With respect to certifications,  for UL certification purposes, we plan to continue to offer certifications to UL 60601 (the 2^nd Edition version of IEC 60601 currently approved in the US by OSHA) for as long as customers have an interest, despite any effective dates by Regulators.  This is due to the fact that many countries have yet to adopt the 3^rd Edition of IEC 60601, and a UL Certification to UL 60601 continues to offer value to manufacturers wishing to demonstrate due diligence in compliance with safety standards with Regulators in those countries.

• July 2012 - Amendment 1 of IEC 60601 3rd edition Passes Vote

  The voting members of the National Committees overwhelmingly voted "Yes" in favor of publishing the IEC 60601 3^rd edition Amendment 1 FDIS as an International Standard.  The ballot was circulated in late April 2012, with a closing date of June 29, 2012.  Now that the National Committees have voted, the IEC will need to formally issue the Amendment before it may be recognized and transition dates are established. 

• April 2012 - Software, 60601 and the Essential Requirements of the MDD

  The Essential Requirements of the MDD effectively require that any software incorporated into a medical device be subject to a software development lifecycle process.   Traditionally, manufacturers relied upon the harmonized standard EN 60601-1-4 to meet these requirements.  However with the DOCOPOCOSS of the 2^nd edition of EN 60601-1, and with it the collateral standards including EN 60601-1-4, compliance with the essential requirements can no longer be claimed after 1 June 2012 (products subject to a part 2 standard – EN 60601-2-xx or EN 80601-2-xx are subject to the DOCOPOCOSS of that standard and not the date for the general standard alone.) The presumption of conformity of the software development process to the essential requirements after the DOCOPOCOSS may be demonstrated by conformance with EN 60601-1:2006 cl 14.4 or EN 62304:2006.  Manufacturers should note that any presumption of conformity based on a harmonized standard is determined in direct correlation with the limitations of the presumption of conformity stated in the Annex Z of the standard utilized. Manufacturers should be aware that an Amendment to EN 60601-1:2006 is presently in discussion and that this is likely to strengthen the software development lifecycle requirements of clause 14.4 of the standard by including additional normative references to requirements in EN 62304 (specifically subclause 4.3, and clauses 5, 7, 8 and 9).   Software requirements continue to evolve as do the related European directives and other international regulatory requirements.  As such, manufacturers will need continued vigilance over the regulatory landscape to ensure compliance today and into the future. If you have software in your device, you may want to discuss your plans for continued conformity with your Notified Body and Certification Agency; UL is ready to support these discussions.