Hi All,
Before I get into Dan's questions I want to remind people about the article I wrote recently
for InCompliance Magazine that I think many of you will get benefit out of so I wanted to share the article "How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World - Standards and Regulatory Update on Medical Electrical Devices" click here. Or you can download the whole magazine with this link. See my original post on this thread to provide any feedback.
In Response to Dan's questions (You never seem to ask simple questions Dan - :) ):
The CB Scheme (IECEE) TRF or Test Report Form you are referring to is at revision K for IEC 60601-1:2005 + A1:2012. You can find the current list of TRFs at
https://www.iecee.org/dyn/www/f?p=106:61:0 (which many older TRF versions are available as test labs are allowed to test to older versions of standards). You can search for Med (not Medical as not the category name) or 60601 or similar terms in the white "Table search:" box on the right side but not quite at the top of the page to make the list much smaller than the many other standards that also have TRFs for the many other categories outside of medical that the IECEE CB scheme deals with.
Rev K of the TRF has been issued since Nov 2015 (over 2 years ago) and this is the revision of the TRF that the risk management tables in the back of the report were taken out but the Risk Management File requirements are part of the main part of the TRF ( the front part I call it vs the test table section at the back) and integrated into the clauses of the standard that require Risk Management File evidence or other Hazard / Risk based evidence, per the standard. This reduced the overall length of the completed TRFs as they getting very long. The test labs for a CB scheme TRF that is to IEC 60601-1:2005 or IEC 60601-1:2005 + A1:2012 are required to review the risk management documentation in two ways. One that an appropriate ISO 14971:2007 process is in place as a desk audit and also that the required Risk Management File / Risk / Hazard based requirements are provided, again as a desk audit of the documentation. A reminder that as a Type Test standard this is not a life cycle standard and so production and post production issues of Risk Management are excluded specifically from all IEC 60601 based standards.
There are no regional variants to an official IECEE CB Scheme TRF. There are national/group differences and regulatory requirements which are issued as a separate part of IECEE CB scheme overall report but is not part of the CB Scheme TRF for a specific standard (like rev K of IEC 60601-1:2005 + A1:2012 (or ed. 3.1)). Manufacturers have to ask for these otherwise there are not included in the CB scheme test report.
A really important thing to note about the CB Scheme reports is for it to really be an official CB Scheme TRF 1) you need a CB scheme signed certificate & 2) the CB Scheme report has to have the test lab logo and and signed off by the test lab. Many CB reports are not official and this is the way you can call tell the difference. Most of my medical clients don't need the CB scheme extra cost and overhead unless going into Korea (just found out that Korea requires a CB scheme report for the regulatory submission) or their regulatory group insists on it.
Thx for the idea of another article. I write one to two per year and they need to be approved by the editors I work with. This is one of many topics I can write on so you will have to wait and see. Sorry can't give you a definitive but as you know article do take a lot of work and time to put together.
Thx much,
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 10-Jun-2018 15:38
From: Dan O'Leary
Subject: Article on Medical Electrical Equipment Keeping up to Date on Standards & Regulatory Changes
I do a lot of training in medical device risk management (ISO 14971:2007 and EN ISO 14971:2012). There are some standards that require an ISO 14971:2007 risk management system. One of them is IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012 (aka Edition 3.1 according to the IEC website). (The article says the latest version is IEC 60601‑1:2005 + A1:2012 + COR1:2012 + ISH3:2013 + COR1:2014. I don't, yet, know how to name this in the Edition 3.x format.)
My question deals with the associated Test Report Forms, TRF, from the IECEE.
Initially, the TRFs had tables that required, depending on the requirement, entries keyed to the clauses of ISO 14971:2007. The test house would then ask for the associated documentation from the risk management file and render an opinion on the documentation's acceptability.
Recently, somebody told me that the TRFs are under revision to eliminate these tables and that the test houses will no longer review the risk management file.
I have two questions.
What is the status of the TRFs in the IECEE scheme related to ISO 14971:2007?
It appears to me that the IECEE scheme, including ISO 14971:2007 and regional variants of the TRFs, is worthy of an article on its own. Would you be willing to write it?
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 10-Jun-2018 15:06
From: Leonard Eisner
Subject: Article on Medical Electrical Equipment Keeping up to Date on Standards & Regulatory Changes
Hi All,
I recently wrote an article for InCompliance Magazine that I think many of you will get benefit out of so I wanted to share the article "How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World - Standards and Regulatory Update on Medical Electrical Devices" click here. Or you can download the whole magazine with this link.
Enjoy and let me know your thoughts on the article. I have gotten some really good feedback already and always looking for more.
Also, if you want to read previous articles I have written for InCompliance Magazine please go to this link.
Thx and keep the feedback coming in. Please feel free to repost these links but if you want to repost any of the articles in full or partially you will need to contact the editors of InCompliance Magazine for their permission.
Cheers,
------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------