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 aligned standards needed to be withdrawn as 2^nd edition of IEC 60601-1 has been withdrawn since the publication of 3^rd edition back at the end of 2005.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• IEC 60601-1 Ed. 2.2 (IEC 60601-1:1988+A1:1991+A2:1995) was withdrawn in 2005, yet those who want to use it have been able to do so for the past seven years.
• IEC 60601-1 Ed. 2.2 makes normative reference to a number of supporting standards that have been revised or superseded, yet users have been able to find the versions they need to implement Edition 2.2.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.

The EU Commission has advised that the disappearance of EN 980 was a mistake and it is still Harmonized and will be corrected at the next release of the updated Harmonized Standards Listing, hopefully in the next few months.   The EU Commission didn’t Harmonize the EN ISO 15223-1 because they saw issues in relation to the Directives (MDD, AIMDD, & IVDD) and Annex Z’s (e.g. Annex ZA, ZB, ZC) of the standard EN ISO 15223-1:2012.  Because the standard EN ISO 15223-1 wasn’t Harmonized under this last round by the EU Commission CEN extended the date of withdrawal of EN ISO 15223-1:2012 from Jan 31, ‘13 to Jul 1, ’15.

For access to the current list of Harmonized Standards, published Jan 24, ’13, they are available thru our previous post FDA & EU MDD / AIMDD / IVDD Updated Standards Lists.

Christine Ruther, an Eisner Safety Consultants Associate reminded us

“The directives already allows the use of symbols from non-harmonized standards with the stipulation that the symbols and colours must be described in the documentation supplied with the device (e.g., MDD Annex I item 13.2).  As most manufacturers define all symbols, regardless of origin, this gap in a harmonized standard for symbols should not be an issue.

In any event, manufacturers are expected to take a common sense approach to managing the situation.  This will likely entail writing a short quality plan that acknowledges the situation and defines what actions will be taken.  Actions might include waiting for the next update of harmonized standards to confirm which standards are harmonized, reviewing existing use of symbols to confirm compliance with EN ISO 15223-1 in anticipation of the change, or other actions.”  NOTE: It is not clear, at this point, if the EU Commission will Harmonize EN ISO 15223-1:2012 for the next publication of the List of Harmonized Standards for the MDD, AIMDD, & IVDD.

For Christine’s part of this post we should also thank NSAI for forwarding information on this momentary vacuum.

The Federal Register notice (FR Notice) continues with details about the workshop.  The public workshop is free with registration (please register early) and will be held on April 29 – 30, 2013 at the FDA White Oak Campus at 10903 New Hampshire Ave, Bldg 31 Conference Center, the Great Room (room 1503A), Silver Springs, MD 20993. To register for the workshop visit the FDA’s Medical Devices News & Events – Workshop & Conferences calendar.  There is also an option for a Webcast to view the workshop from off-site web facilities.  To sign-up in this way use the same registration link as above but make sure to note that you want to attend via a webcast vs in person.  The contact person for this workshop is Mary Brady, Mary.Brady@fda.hhs.gov who is also involved with the Home Use Medical Device Initiative so this is a good tie-in with that subject as labeling is critical to get consistent for ease of use or Usability (or Human Factors some call it).  Refer to the blog post on the Home Use Medical Device Draft Guidance document that was issued on 12 December 2012 for details about the Home Use Draft Guidance document and also about the Home Use Initiative.

In the background section of the FR Notice for this Workshop FDA indicates “Currently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling. FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error. Also, there is no single available source of medical device labeling for people to view, search, and download for devices that are used in clinical and non-clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost or inaccessible labeling.”

FDA also conducted a 2-phase research study with Research triangle Institute (RTI) of healthcare professionals in regard to their experiences with medical device labeling, and what they would like to see in a standardized version of device labeling. Key findings from the study helped create an outline for standard content and format for medical device labeling id’ing the most relevant sections.  Also, survey participants asked for a “quick reference guide”  for proper device operation & use.  They indicated that would be more convenient and effective with the option of referring to a more comprehensive form of labeling.

Additionally FDA also conducted a survey of the National Family Caregivers Association (NFCA) on medical device labeling to elicit home caregivers’ experiences with medical device labeling for devices used in the home environment.  Here again is another tie-in with the Home Use Medical Device Draft Guidance document and blog post on this subject.  It is clear this initiative is tied-in with the Home Use Initiative and will help support each of the initiatives.  FDA continues to say in the FR Notice “As more medical devices migrate out of clinical care environments and into patients’ homes, the assurance that devices are being used properly and safely no longer resides with a healthcare professional; rather, the responsibility is with the patient, spouse, sibling, or even children. When medical devices are sent home with patients or are moved from one location to another, the labeling often becomes misplaced, lost, damaged, or discarded, which may result in adverse events or other complications due to misinterpretations and absence of proper labeling.”

Per the FDA FR Notice the workshop will focus on the following topics for discussion

A. Summary of FDA Work on Labeling

1. RTI two-phase research study of healthcare professionals regarding device labeling.
2. NFCA survey of consumers on medical device labeling.
3. Cooperative Research and Development Agreement with Kwikpoint for the development of visual language for device labeling.
4. The Center for Drug Evaluation and Research measures of success with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

1. Review the outline for a draft standard content and format of medical device labeling.
2. Current thinking on a standard content and format of medical device labeling.
3. Use of symbols in medical device labeling.
4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

1. Online access to device labeling.
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the site.

For additional information on the topic also refer to the RAPS News article on 4 Jan 2013.

Audio Conference is on Wednesday Nov. 18, 2009, 1:00pm – 2:00pm Eastern Time, 60 minutes

Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX conferences website

Audio conference highlights

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices! Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too.

In this audio conference, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from the second edition, changes you need to know about for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

This audio conference covers:

• How risk management relates to labeling and marking
• New testing requirements under IEC 60601-1 3rd edition
• The important document you need for “proof of compliance”

Who should attend?

• Product safety engineers
• Regulatory affairs
• Technical writers
• R&D engineers

Sign-up for the audio conference right here and use promo code AF2009EIS for a $50 discount on this event only