ESC – Eisner Safety Consultants

IEC 60601-1-9 required for Brazil Near End of 2016

leoeisner — Wed, 06 Apr 2016 00:47:39 +0000

Brazil IEC 60601-1-9 required Near End of 2016 – Are You Ready?

ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015 (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 + Amendment 1:2012 (Edition 3.1 or 3rd edition + Amendment 1). This standard is required for any new product seeking ANVISA approval since September 24, 2015 and going forward.

Before we get to the 60601-1-9 issue let’s talk a little about which version of 60601-1 applies. If you have an INMETRO certificate that met 60601-1 3rd ed. you are ok until you have to rectify your product or your certificate expires. If the Particular Standard 60601-2-XX is still based on the 2nd ed. of 60601-1 then you still can use the 2nd edition of 60601-1. But check the IN 4 before you move forward that way to make sure you are using the proper version of the applicable standards. For the EMC standard you only need to deal with the 60601-1-2 3rd ed. which is equivalent to the 2007 edition of IEC 60601-1-2 and is the less stringent standard compared to 4th ed of 60601-1-2.

Along with 60601-1 there were a long list of other 60601 based standards in the Notice including the 60601-1-9 standard for “environmentally conscious design of medical electrical equipment”. If you would like a copy of this notice please e-mail me at Leo@EisnerSafety.com. I believe that Brazil is the first country that is mandating the use of 60601-1-9 . The full IEC standard title is “IEC 60601-1-9:2007 + Amendment 1:2013 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design“. The Brazilian version of the standard is ABNT NBR IEC 60601-1-9:2014 which is translated into Portuguese and the text is identical to IEC 60601-1-9:2007 + A1:2013.

ANVISA is requiring compliance to the standard by December 1, 2016 specifically for the clauses 4.1, 4.5.2 and 4.5.3 of the standard. So, the documentation needed will include the identification of environmental aspects (clause 4.1), instructions for minimizing environmental impact during normal use (clause 4.5.2), and information for end of life management (clause 4.5.3).

If you need help with IEC 60601-1, any in the Series of Standards or any National Version of these standards please email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

BSI White Paper on Human Factors & Usability

leoeisner — Fri, 27 Feb 2015 23:15:35 +0000

Blog focus BSI’s 7^th in a series of White Papers for Medical Device, on Human Factors & Usability Engineering

White Paper on The growing role of human factors and usability engineering for medical devices

This white paper is on “The growing role of human factors and usability engineering for medical devices”and is focused on “…applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.” It is written by Bob North, Human Centered Strategies.

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series

This is the last planned white paper in this series of white papers. BSI said of the series that “…we are…producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The other white papers in the series you may be interested in reading, as they are very timely and current, are below:

Negotiating the innovation and regulatory conundrum
Engaging stakeholders in the home medical device market
What you need to know about the FDA’s UDI system final rule
Effective post-market surveillance; Understanding and conducting vigilance and post-market clinical follow-up
The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market
Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance

You can sign-up for future white papers or sign-up for their industry sectors newsletter.

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers or preparing for your Notified Body Audit, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

BSI White Paper on Generating Clinical Evaluation Reports

leoeisner — Sat, 31 May 2014 19:35:45 +0000

Blog focus BSI’s 2^nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports

White Paper on Generating clinical evaluation reports

This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).” It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI .

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The additional white papers in the series will be on:

The digital patient
What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
Post-market surveillance
Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website).

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Welcome 2 Experts to the Eisner Safety Consultants Growing Team

leoeisner — Thu, 29 May 2014 05:43:03 +0000

I would like to let all of you know of two experts that have joined the Eisner Safety Consultants team recently which will help us support a growing need for IEC 60601-1, 3rd edition and edition 3.1 projects that we are continually supporting. These two individuals come with great experience and are a fantastic addition to our company. Please welcome Bruce Nelson and Dale Hallerberg to our growing team that can support your medical device regulatory, safety certification, and quality system needs. To find out more about their backgrounds please check out our Associates web page.

If you need additional support for IEC 60601-1, 3rd edition + A1 email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Update to BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

leoeisner — Wed, 23 Apr 2014 17:09:18 +0000

BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.

Refer to the previous blog post on BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s for additional details about the white paper and the Series of white papers.

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website).

BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

leoeisner — Thu, 10 Apr 2014 00:34:13 +0000

This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations

9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.

White Paper on Proposed EU Regulations

This initial white paper is on the “The proposed EU regulations for medical and in vitro diagnostic devices” and is focused on “An overview of the likely outcomes and consequences for the market”. It is written by some of the best authorities in the business, on this subject, Gert Bos of BSI Head of Regulatory and Clinical Affairs and Erik Vollebregt Partner at Axon Lawyers, that I personally know and trust. I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

BSI states that this white paper reviews “the proposals for the new medical devices (MDR) and IVD regulations (IVDR) will provide a new regulatory framework for medical devices in the EU for the coming decades. Although crucial elements of the regulations are still subject to political debate, one thing is clear – the regulations will cause important changes for you. Use this white paper to find out how to prepare for these changes.”

White Paper Series and Future Topics to Come

The additional white papers in the series will be on:

Generating clinical evaluation reports: A guide to effectively analyzing medical device safety and performance
The digital patient
What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
Post-market surveillance
Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website).

IEC 60601-1, 3rd ed. related standards changes & new Interpretation Sheet 3

leoeisner — Fri, 14 Jun 2013 06:29:34 +0000

IEC 60601-1, 3^rd ed. has been out for about 7 years now and there have been lots of changes within the IEC 60601 series of standards to align with 3^rd edition.

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.

Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance

leoeisner — Mon, 10 Jun 2013 20:19:19 +0000

Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 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: 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.

RAPS & Medicaldeviceslegal.com EU Medical Devices Regulation Chart

leoeisner — Fri, 03 May 2013 03:27:08 +0000

This Regulation Chart & the blog post contents is Thx to Medicaldeviceslegal.com and the RAPS Dutch/Flanders chapter. We are grateful to them for sharing such a valuable tool and hope you get a lot of good use from it too. All they ask you do is to provide them with feedback if you have ideas of additional items to add to the listing.

On 30 April 2013 the Medicaldeviceslegal.com website via Axon Lawyers posted a really helpful new document for your use (free of charge and no request for info about you or your company). The RAPS Dutch/Flanders chapter has been active in defining a list of EU legislation that does not directly regulate medical devices but covers them in its scope, like environmental design requirements for electronic devices. From this listing Axon Lawyers expanded the document into an English language document that includes active links to the underlying legislative texts, the EU law summaries in the ScadPlus database, if available, and to the EU Commission web pages with explanation about the rules concerned.

Axon Lawyers mentioned that this list will always be in constant flux because these rules tend to be amended a lot. So, the best place to download this chart is directly from their blog posting. If you want to just download this version of the chart click here for now but check back with their website (Medicaldeviceslegal.com) to look for updates. At this point they haven’t decided how they will distribute updates to this chart but I am sure they will figure something out and disseminate, as appropriate. Stand tuned for more updates on this valuable resource and let’s again thank both the RAPS Dutch/Flanders chapter and Medicaldeviceslegal.com website for this resource they are sharing with us.

Reminder Presentation on IEC60601-1, 3rd edition, Amendment 1 & its Impact on Users on 2 May ’13

leoeisner — Thu, 25 Apr 2013 23:55:32 +0000

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.

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.