Are you struggling with your IEC 60601-1 3rd edition testing lab?
R
robertjbeck
Hi there,
This may be too late for your research project. I have had a lot of problems with third-party test houses, mostly relating to communication.
1. Tester misunderstands standard because English is not the tester's native language. Takes me a while to figure out that the standard is being misapplied, tester wants documentation of my position, but eventually accepts it. This particular type of problem has happened with two testers, one of whom was adamant that he understood the words and definitions so I wrote a three-page essay complete with photographs to explain, and it was eventually accepted. Another situation was with a standard that had several clauses ending with ", if applicable." They were not applicable, but tester could see that clause and acted as if they were always applicable. In this case, the device company gave up and ended up bypassing the test house and self-certifying to the standard.
2. Tester does not explain why something failed in an understandable way. This has happened to me primarily with label contents.
3. Account manager answers a question and you find out three months later that the test was not the right one or it did not include all of the applicable national differences. This happened to me with an Asian country that I specifically asked about in reference to the test house's quote, was told that it was included, then three months later was told that it was not included. Even though I have the email message stating it was included, the fact is that not all of the required testing was done so the complete national differences cannot be added to the report.
4. 60601 3rd edition is a very long standard, and sometimes it's not clear why a specific item is marked as not passed. and it's not clear what to do about it.
5. General questions are difficult to get answers to. For instance, when does a device need the UL or ETL mark.
This may be too late for your research project. I have had a lot of problems with third-party test houses, mostly relating to communication.
1. Tester misunderstands standard because English is not the tester's native language. Takes me a while to figure out that the standard is being misapplied, tester wants documentation of my position, but eventually accepts it. This particular type of problem has happened with two testers, one of whom was adamant that he understood the words and definitions so I wrote a three-page essay complete with photographs to explain, and it was eventually accepted. Another situation was with a standard that had several clauses ending with ", if applicable." They were not applicable, but tester could see that clause and acted as if they were always applicable. In this case, the device company gave up and ended up bypassing the test house and self-certifying to the standard.
2. Tester does not explain why something failed in an understandable way. This has happened to me primarily with label contents.
3. Account manager answers a question and you find out three months later that the test was not the right one or it did not include all of the applicable national differences. This happened to me with an Asian country that I specifically asked about in reference to the test house's quote, was told that it was included, then three months later was told that it was not included. Even though I have the email message stating it was included, the fact is that not all of the required testing was done so the complete national differences cannot be added to the report.
4. 60601 3rd edition is a very long standard, and sometimes it's not clear why a specific item is marked as not passed. and it's not clear what to do about it.
5. General questions are difficult to get answers to. For instance, when does a device need the UL or ETL mark.
I understand the frustration of manufacturers dealing with the 3rd edition, but we have to take care of blaming the test labs.
The core problem is with the standard, which was written from a regulatory perspective (in particular, EU regulations), not for test labs. Given the scope of the standard, it is little wonder labs are not charging US$250,000 or more. For areas such as risk management, essential performance and programmable systems, the standard is poorly written and test labs are left struggling to even keep staff who are willing to deal with it.
Ideally the standard would have been split into two sections: part A which is written with clear, testable objective specifications, and Part B dealing with subjective areas like risk management, programmable systems, usability and so on. Part A is deliberately written in a way that fits within the framework of laboratory systems (ISO 17025) and product certification (Guide 65), with Part B written using management systems, intended for manufacturers to implement under their own responsibility, and subject to regulatory audit under the framework that is normally used for regulation (e.g. Guide 62, ISO 17021, 19011).
There may also be some interface between the two (e.g. specifications of Part A can be the output of Part B) but the important point is that the test lab is not responsible for the content of the specification, only the accuracy of the tests according to the specification.
Product certification schemes like NRTL/SCC marks should primarily work in Part A, and if any of Part B is required, there should be boundaries which allow for practical assessments, e.g. NRTL limits to basic safety (electric shock, mechanical injury, fire, thermal etc) which are incidental to the clinical purpose.
The CB scheme must be limited to Part A since it does not have the structure to handle Part B, and it is unable to provide value for money nor improve safety. In fact, the attempt to handle Part B under the CB scheme at the moment is reducing safety, as it forces test labs to write reports for things they are not qualified to handle.
In the context of regulations, a manufacturer should be able to voluntarily select what parts of the compliance are assessed by third parties.
Part A should be structured so that manufacturers can get value for money by using a third party test lab, i.e. it should cost less to do in an external lab than it would to do in house. The external lab has the equipment and experience which allows efficient service. A budget of US$10,000 should be plenty to evaluate Part A for most devices.
Part B could be subject to voluntary audit, but any company that provides the audit should be genuinely qualified in technology of the product, and be able to take partial responsibility for the results (to the extent of the audit).
Of course, all of this is just a pipe dream
The core problem is with the standard, which was written from a regulatory perspective (in particular, EU regulations), not for test labs. Given the scope of the standard, it is little wonder labs are not charging US$250,000 or more. For areas such as risk management, essential performance and programmable systems, the standard is poorly written and test labs are left struggling to even keep staff who are willing to deal with it.
Ideally the standard would have been split into two sections: part A which is written with clear, testable objective specifications, and Part B dealing with subjective areas like risk management, programmable systems, usability and so on. Part A is deliberately written in a way that fits within the framework of laboratory systems (ISO 17025) and product certification (Guide 65), with Part B written using management systems, intended for manufacturers to implement under their own responsibility, and subject to regulatory audit under the framework that is normally used for regulation (e.g. Guide 62, ISO 17021, 19011).
There may also be some interface between the two (e.g. specifications of Part A can be the output of Part B) but the important point is that the test lab is not responsible for the content of the specification, only the accuracy of the tests according to the specification.
Product certification schemes like NRTL/SCC marks should primarily work in Part A, and if any of Part B is required, there should be boundaries which allow for practical assessments, e.g. NRTL limits to basic safety (electric shock, mechanical injury, fire, thermal etc) which are incidental to the clinical purpose.
The CB scheme must be limited to Part A since it does not have the structure to handle Part B, and it is unable to provide value for money nor improve safety. In fact, the attempt to handle Part B under the CB scheme at the moment is reducing safety, as it forces test labs to write reports for things they are not qualified to handle.
In the context of regulations, a manufacturer should be able to voluntarily select what parts of the compliance are assessed by third parties.
Part A should be structured so that manufacturers can get value for money by using a third party test lab, i.e. it should cost less to do in an external lab than it would to do in house. The external lab has the equipment and experience which allows efficient service. A budget of US$10,000 should be plenty to evaluate Part A for most devices.
Part B could be subject to voluntary audit, but any company that provides the audit should be genuinely qualified in technology of the product, and be able to take partial responsibility for the results (to the extent of the audit).
Of course, all of this is just a pipe dream
I will comment from the accrediting body (AB) perspective. We have been getting a lot of accreditation requests for IEC 60601-1 and -2-xxx.
Part of it is being driven by a couple of economies that do not accept CB Scheme.
However, for accreditation we go in and do an assessment. We check the quality side of course, such as contract review. Then we observe demonstrations to assure that the laboratory is what is known in accreditation, as competent. That is, they have the equipment, personnel, knowledge, and system to conduct testing per the applicable standard, and they can conduct the testing properly.
Now, due to the extent of the testing and the time involved, it is expensive. Some tests are detailed, some require quite some time to complete, and all that means more cost.
Whether the standard should be changed, and how, has to be decided by someone else, but in the meantime, the testing is conducted to the published standards.
Part of it is being driven by a couple of economies that do not accept CB Scheme.
However, for accreditation we go in and do an assessment. We check the quality side of course, such as contract review. Then we observe demonstrations to assure that the laboratory is what is known in accreditation, as competent. That is, they have the equipment, personnel, knowledge, and system to conduct testing per the applicable standard, and they can conduct the testing properly.
Now, due to the extent of the testing and the time involved, it is expensive. Some tests are detailed, some require quite some time to complete, and all that means more cost.
Whether the standard should be changed, and how, has to be decided by someone else, but in the meantime, the testing is conducted to the published standards.
S
Sarah Stec
I'm checking in with this thread, as I saw that there were a few new posts to it - thank you all very much. The research project is always ongoing (continuous improvement at work!) and as time marches on it's a good reminder of the gap between telling someone to "implement!" and actually implementing. I'm also quite glad that we have a good discussion going. 
Keep 'em coming!
Keep 'em coming!
Two posts in this thread I want to comment on, Evike's post gives details of frustrations I can identify with (every one mentioned...precisely my experience), and Peter Selvey, a great perspective on the source of these frustrations...
Great posts guys!
Evike's post basically deals with the cost-side from manufacturer's perspective. These tests are super expensive, and there's often no way to get the price down, regardless of the nature of the device...
Peter Selvey's suggestions I think are brilliant. In particular:
Great ideas! We can only hope...
Great posts guys!
Evike's post basically deals with the cost-side from manufacturer's perspective. These tests are super expensive, and there's often no way to get the price down, regardless of the nature of the device...
Peter Selvey's suggestions I think are brilliant. In particular:
Great ideas! We can only hope...
T
tomshoup
If you can stand one more answer 2 years after your post.......
I'm an independent med dev consulting engineer and recently ran a client's (US class 1 exempt) device through a NRTL for 60601 3rd ed. testing as well as 60529 ingress protection. This included the examination of the risk management file, which I had created for my client.
I had created the RM file from scratch, carefully following 14971, and received zero questions from the NRTL. My basic technique was to have a document which corresponded with each of the major steps in risk analysis. For example, I created a document titled "Hazard Identification" in which I captured all the hazards and hazardous situations we identified through various means: FMEA, those stated directly in 60601-1, review of the FDA MAUDE database, and other means. So when I filled out the RM questionnaire, it was easy to answer yes and point to documents with the appropriate title. Some materials weren't available when we did the testing because formal V&V wasn't complete, but the test lab accepted an IOU and when the V&V reports were done accepted them and closed out the RM examination.
For the actual testing, I found the lab accommodating. We discussed what the "worst case" conditions were in which to place the equipment and always arrived at an agreeable outcome. This device used carbon fiber components, which are slightly conductive, so there was a good discussion about how to do the hi-pot testing. Again, the lab was willing to discuss the conditions of the test and we reached an agreeable outcome.
Was it expensive? Yes, maybe $35K for a CB format report plus almost a week of my time at the test lab since I had to operate the equipment for long periods to get thermal equilibration. My only disappontment was the test lab would not accept the 60601 cert. of the power supply from its manufacturer, so I had to remove it from the device and disassemble it so the NRTL could put thermocouples inside. This then caused problems later with hi-pot testing, since the thermocouples allowed arcing, so that caused another disassemble/re-assemble cycle to remove the TCs.
My client is happy with this test lab and has used them for years. Part of their decision to stick with them is the long history they have from their inspections for the listing report. Medical device manufacturers are somewhat held hostage by the NRTLs due to the inspections they perform for listing so the switching cost is high to go to a new NRTL.
I'm an independent med dev consulting engineer and recently ran a client's (US class 1 exempt) device through a NRTL for 60601 3rd ed. testing as well as 60529 ingress protection. This included the examination of the risk management file, which I had created for my client.
I had created the RM file from scratch, carefully following 14971, and received zero questions from the NRTL. My basic technique was to have a document which corresponded with each of the major steps in risk analysis. For example, I created a document titled "Hazard Identification" in which I captured all the hazards and hazardous situations we identified through various means: FMEA, those stated directly in 60601-1, review of the FDA MAUDE database, and other means. So when I filled out the RM questionnaire, it was easy to answer yes and point to documents with the appropriate title. Some materials weren't available when we did the testing because formal V&V wasn't complete, but the test lab accepted an IOU and when the V&V reports were done accepted them and closed out the RM examination.
For the actual testing, I found the lab accommodating. We discussed what the "worst case" conditions were in which to place the equipment and always arrived at an agreeable outcome. This device used carbon fiber components, which are slightly conductive, so there was a good discussion about how to do the hi-pot testing. Again, the lab was willing to discuss the conditions of the test and we reached an agreeable outcome.
Was it expensive? Yes, maybe $35K for a CB format report plus almost a week of my time at the test lab since I had to operate the equipment for long periods to get thermal equilibration. My only disappontment was the test lab would not accept the 60601 cert. of the power supply from its manufacturer, so I had to remove it from the device and disassemble it so the NRTL could put thermocouples inside. This then caused problems later with hi-pot testing, since the thermocouples allowed arcing, so that caused another disassemble/re-assemble cycle to remove the TCs.
My client is happy with this test lab and has used them for years. Part of their decision to stick with them is the long history they have from their inspections for the listing report. Medical device manufacturers are somewhat held hostage by the NRTLs due to the inspections they perform for listing so the switching cost is high to go to a new NRTL.