Introduction of IEC 60601-1 (third edition) with amendments

They will be requiring that for electrical medical devices these products will need to meet IEC 60601-1, 3^rd ed. (2005) + Amendments*.   This requirement is effective for Class 3 & 4 medical devices as of June 1 2014, for Class 2 medical devices as of June 1 2015 and lastly for Class 1 medical devices as of June 1 2016.

* Depending on what this Amendment to the Medical Devices Act consider Amendments it could be just Amendments of the standard or it could include & probably should consider the Corrigendums and Interpretation Sheets too.   All the possible current Amendments are Amendment 1:2012 + Corrigendums 1:2006 and 2:2007 for 3^rd ed. and Corrigendum 1:2012 for ed. 3.1 + Interpretation Sheets 1:2008, 2:2009, & 3:2013.

The notice also states that MFDS will lay down new safety standards for software as medical electrical equipments.  My guess is that they will require complying with IEC 62304 which is the standard for Medical Device Software Lifecycles as it has become very popular around the world for many national regulatory bodies.  We will have to wait and see what happens for this requirement, as the notice is not clear as to what standard(s) they will use as of now.

Introduction of the Summary Technical Documentation (STED)

As of January 1 2014 Class 4 medical device applicants (except for IVD reagents) will be required to submit in the the STED format.  MFDS says that this will expedite the review timelines for the manufacturers and devices that are submitted.  Class 1, 2, & 3 devices have the option of submitting in the STED format as of the date for the notification.

Revised “Regulations on Classification and Grades”

MFDS announced several changes for the regulations on classification and grades covering the following issues:

• 94 new products are added under “cell manipulating kit for medical use”.
• Definitions for 108 products have changed including for “heater systems”.
• The Class of “dental color measuring devices” was down-classified to Class 1.
• 67 commercial names including “warm bath equipment” are edited out.
• The changes are effective as of the date of notification.

Last summer Amendment 1 (A1) came out and if you haven’t yet you should start learning about those changes as they will be impacting you sooner rather than later (sign-up for an FX Conferences recording of my recent presentation on A1 of IEC 60601-1 and its’ impact on users, follow the instructions to get a $50.00 discount, and sign up for the presentation titled “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users”) and also A1 can help you as it will reduce the amount of Risk Management File work you need to do for a product safety certification or approval. There are about 25 less Risk Management File requirements when using A1 vs using 3^rd ed.  To understand the differences and changes of A1 it is highly recommended that you get the IEC 60601-1 edition 3.1 (consolidated) edition as that shows you where all the changes are to the text vs 3^rd ed.  Note, when you submit for testing thru a test lab you will either want to use either edition 3.1 or 3^rd ed. but you can’t mix and match as that would not work well and any CB scheme certified lab, among most other labs, will not mix and match requirements as it gets messy quickly.

So, what are the current changes to the standards related to alignment with 3^rd ed. & the new Interpretation Sheet?  Let’s start with the standards.

The updates are actually withdrawal of two standards that have been embedded into 3^rd ed. when it was released (i.e. IEC 60601-1-1, 2^nd edition – Medical Electrical Systems & IEC 60601-1-4 Programmable Electrical Medical Systems) and so the 2^nd ed. aligned standards needed to be withdrawn as 2^nd edition of IEC 60601-1 has been withdrawn since the publication of 3^rd edition back at the end of 2005.  The withdrawal report to IEC for IEC 60601-1-1, Edition 2.0 (now in IEC 60601-1, 3rd ed. in clause 16) covered the following 3 points, and it is the same circumstances for IEC 60601-1-4, edition 1.1 (1^st ed. + A1) (now in IEC 60601-1, 3rd ed. in clause 14):

• IEC 60601-1 Ed. 2.2 (IEC 60601-1:1988+A1:1991+A2:1995) was withdrawn in 2005, yet those who want to use it have been able to do so for the past seven years.
• IEC 60601-1 Ed. 2.2 makes normative reference to a number of supporting standards that have been revised or superseded, yet users have been able to find the versions they need to implement Edition 2.2.
• With the changes made in Amendment 1 to IEC 60601-1:2005, there are substantive technical differences between this collateral standard and its respective clause in IEC 60601-1 Ed. 3.1. Therefore, this document can no longer be considered to represent the generally accepted state of the art.

Let’s move onto the Interpretation Sheet 3 (or IS3) for IEC 60601-1 3^rd edition and also for edition 3.1 or 3^rd edition + A1.  It is the 3^rd interpretation sheet issued since IEC 60601-1, 3^rd edition has been issued.  IS3 is a clarification of the requirement for sub-clause 13.1.2, 4^th dashed line which the sub-clause is titled “Emissions, deformation of ENCLOSURE or exceeding maximum Temperature”.  The requirement of concern is:

“The following HAZARDOUS SITUATIONS shall not occur;”

“- ….”
“-     temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be touched, exceeding the allowable values in Table 23 when measured and adjusted as described in 11.1.3;”  (This is the fourth dashed line of 13.1.2)

So, this requirement is saying that this situation should not occur (following HAZARDOUS SITUATIONS) if there is a part that isn’t an APPLIED PART (An APPLIED PART is a part of the device that in NORMAL USE necessarily comes into physical contact with the PATIENT for the device to perform its function.  So, a part other than an APPLIED PART) that is likely to be touched that exceeds the temperature limits of Table 23 (Allowable max temperatures for ME EQUIPMENT parts that are likely to be touched) in the temperature test method described in sub-clause 11.3.

The IS3 gives an alternative route to meeting the above requirement by stating the following:

“This is clarified by the following:

The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:

− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT CONDITION is 105 °C; and

− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the temperature of: (indicate the surface of concern) could get hot and there is a possible RISK of a burn if touched, and

− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the ENCLOSURE; and

− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT CONDITION is acceptable, and

− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL RISK resulting from applying the requirement of the standard.

NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.

NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is shown below.”

To access this IS3 for free please go to the IEC website link.

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.

What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

It’s just under one week away from this big presentation.  I (Leo) have been working tirelessly to get the presentation in tip top shape and there will be lots of helpful information in the PowerPoint presentation.  So, sign-up now to take away a really useful summary document of the more important changes to IEC 60601-1 under Amendment 1 changes.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 discount.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.
Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.
Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Either way this is a great resource and is useful to get a grip on the breadth of changes made for A1 and also if you are still getting your feet wet with 3^rd ed. of IEC 60601-1 (many companies are still just starting along this process) there are still items that were in 1st ed. of IEC 62348 that are still of great resource to you.  

With the release of A1 of IEC 60601-1 on July 13, ‘12 (consolidated edition 3.1 published Aug 20, ’12) & the US National Version ANSI/AAMI ES 60601-1:2005/A1:2012 there were a significant number of changes made to the 60601-1, 3^rd edition.  There were 182 identified issues and a total of 496 discrete changes to the 3^rd ed. of 60601-1, which included some significant changes, moderate changes, and some minor typos, as well.  Each of the 496 changes that A1 made were accessed by the developers of the standard to determine the impact on the users of 60601-1.  Many of the changes are only editorial corrections or clarifications so many of the changes (413 changes) were accessed as having minimal or no impact on the application of the standard.  But there were 83 changes that were accessed as having a moderate to significant impact on the users of the standard.  So, IEC TR 62348 “Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition” (here forward will only refer to IEC version as ANSI/AAMI/IEC TIR 62348:12 is the same as no technical changes to the document, just US national version introductory page changes) was updated for the 2^nd edition to add in the Assessment of the impact of these 83 changes, as noted in the title of the standard, and still keep the comparison between 2^nd to 3^rd ed. of IEC 60601-1.  The A1 assessment portion of the Technical Report is split into 2 parts based on the Significant (Table 1) or Moderate (Table 2) Impact on the users of the standard.  This assessment is based on the likelihood that some alterations to the design documentation, testing, the product itself, or its accompanying documents will be required because of the change to a requirement in the A1.  Further within each table the impact is sliced a bit thinner by considering if the issue will Impact many users or impact only particular users like a mechanical requirement that a chunk of devices may not be impacted by.  As these assessments are subjective users of the standard (IEC 60601-1:05 + A1:12) are highly encouraged to review the contents of the A1 and determine its impact on the sections that are relevant to their products.   The easiest way to read the A1 document is the consolidated A1 by IEC as the changes that can be shown are identified in a different color.  The IEC version of the consolidated version (edition 3.1) of IEC 60601-1:2005 + A1:2012 standard can be obtained thru TechStreet.  For the AAMI pdf go to the AAMI standards store and for the print version click here.

The first edition of IEC TR 62348 was originally set up to compare 2^nd to 3^rd ed. of IEC 60601-1 so for those going from 2^nd to 3^rd ed. the document was accessible to any that wanted to learn what type of changes were made and what clauses changed, stayed the same or similar, were new or disappeared.  Also, this document used to be free on the IEC website.  As of the 2^nd edition publication the document isn’t free anymore.  You can purchase the 2^nd ed. of IEC TR 62348:212 or AAMI/IEC TIR 62348:12 from various sources such as TechStreet or AAMI.

IEC is planning on also issuing an updated consolidated version of IEC 60601-1:05 which will include Interpretation Sheets 1 & 2  (IS 1 & IS2), Corrigendums 1 & 2 (Corr 1 & Corr 2), and A1.  They hope to have this out next week.  The IS 1 & 2 and the Corr 1 & 2 are available free on the IEC.ch website (refer to weblinks 2 sentences prior).

The US national version (AAMI) of A1 is in the works and AAMI is hoping to get the approvals done soon so they can also publish it as a US based Amendment as soon as possible but it may take awhile before it gets published as they didn’t expect IEC to publish the document quite so soon.  They are also planning to issue a consolidated version of the AAMI standard similar to the IEC version plus of course it would include the US National Deviations.

A1 addresses 182 issues that have been identified by various interested parties starting prior to the end of the development process of IEC 60601-1, 3rd edition which was published December 2005.  The initial comments that were brought into the A1 project were initiated during the FDIS (Final Draft International Standard) stage of IEC 60601-1, 3rd edition.   Through the A1 process there have been 496 separate changes made to the standard (third edition).  There is a potential Technical Report document that is being discussed and voted on by the National Committees for IEC SC 62A the sub-committee on ‘Common aspects of electrical equipment used in medical practice’, which is in charge of the standard IEC 60601-1 among other standards and technical reports in the IEC 60601-1 series.  This document, if approved, will help users of A1 in assessing the impact of the most significant changes to A1:2012.   In this draft Technical Report state it has identified 83 changes of moderate or significant impact on the user of the standard.  In its’ present state the draft Technical Report also breaks up the impact analysis of the changes into Impact on ‘Many Users’ vs ‘Particular Users’ (a smaller subset of ‘Users’ of the standard).  As this draft Technical Report develops more news will be issued.

If you have any questions in regard to IEC 60601-1 and it’s series of Standards and Technical Reports Eisner Safety Consultants is here to support you in your efforts of meeting and maintaining compliance with applicable Standards.  Please feel free to contact us at Leo@EisnerSafety.com.