Routes to IEC 60601 Compliance: Discussion of Merits and Pitfalls

[Mark Meer]

Hi Everyone,
Thought it'd be helpful and informative to have a thread summarizing various possible routes to 60601 compliance, and their relative merits, shortcomings, considerations and requirements.

Factors worth considering are:

• Cost
• Resources, Technical Expertise
• Documentation
• International recognition

So, here's the list thus far:
Elsmar members: this is my own interpretation. If so inclined, please feel free to correct any errors, add to or clarify... thanks!

OPTION 1: In-House Testing (using own protocols, equipment and test-report forms).

• Merits: Potential cost saving (once protocols and TRF are developed and equipment acquired). Can repeat for other projects.
• Considerations: Potentially subject to more scrutiny from auditors.
• Requirements: Test procedures and control of equipment needs to be thoroughly documented. Repeatability of tests and competence of facility/personnel should be demonstrable.

OPTION 2: Testing by a 3rd-Party, accredited test lab, according to CB scheme.

• Merits: International flexibility. Ability to obtain NRTL marks. Less in-house technical expertise required (competent test-lab should be able to consult and determine required tests).
• Shortcomings: Expensive.
• Requirements: Pick your test-house carefully. Ensure you can communicate effectively and they demonstrate competence and expertise (HINT: try and talk with the actual technicians, and not just the sales reps...).

OPTION 3: Testing by a 3rd-Party, non-accredited test-lab. No CB.

• Merits: Potentially cheaper than option 2.
• Shortcomings: Test reports may not be accepted by certain groups.
• Requirements: Same as option 2, but even more important!

OPTION 4: In-house testing supplemented by 3rd-party testing

• Merits: Cost saving.
• Shortcomings: Potentially complicated to show all requirements are met.
• Requirements: Need technical expertise to select which specific tests need to be done by 3rd-party, which can be done in-house, and which are not applicable.

Other options?
Comments/feedback/discussion welcome!

 

[yodon]

I think there are a few more considerations for the merits of going with a 3rd party (accredited) test lab.

They necessarily are on top of the changing landscape. Given the amount of recent changes, it would be hard to stay up internally.

You don't have to do a CB scheme. That's the most flexible but if you have just specific markets, you can just get testing to those. Again, going with a 3rd party accredited lab can help you limit the testing if that's an option.

(I don't work for a 3rd party lab but have used several... and I can completely agree with the statement about speaking to the techs and not only the sales folks!)

 

[Mark Meer]

It'd be interesting to conduct a poll as to which option companies go with...
Though you'd probably see some variation depending on the device-class/intended-use,
I'm sure you're right in that 3rd-party testing is the overwhelming route.

We have always opted for "Option2" (3rd-party, accredited, CB), because it's "safest". However this is at tremendous cost.

Given what posters such as SteveK and Pads38 have said (see http://elsmar.com/Forums/showthread.php?t=46623), perhaps in-house testing can be a viable alternative...

Also regarding CB/no-CB and accredited/non-accredited, I'd be curious how different companies weigh in...

 

[isoalchemist]

As much as I hate spending the money the 3rd party route is the best for most organizations. With larger organizations that have a significant experience base to call upon that may change, but for smaller organizations the expertise of the 3rd party is critical.

I got pulled into the middle of a 60601 certification that should have been near completion that I ended up pulling back out of the lab so we could fix the stuff we thought was right that we had no clue about. Unless you have the resources, defer to those that do. Long term it will be a lot cheaper.

 

[Mark Meer]

Unfortunately, by industry always opting for the "safest" route of deferring to 3rd party labs, I can't help but think we may be creating a defacto precedence...

In otherwords, the other options will become even less viable, because of the scrutiny they'll be subject to given how rare it is for companies to self-test.

It's also creating an environment where we are really at the mercy of the test-houses. The "they know best" attitude enables them to charge whatever they like, and I'm not totally convinced that the quality of work/expertise is any better than what you could potentially get in-house...

 

[Mark Meer]

I'd like to revive this thread to further discuss the CB/non-CB, and accredited/non-accredited test lab options....

Regarding the CB scheme:
I know that using the CB scheme facilitates transfer of reports to another NRTL, but are there any other reasons to go with the CB scheme?
Our test-lab charges a hefty premium for CB scheme, and I'm struggling to justify the value... In a regulatory context, does presenting 60601 CB reports carry any added weight/recognition by, for example, notified bodies or FDA 510(k) reviewers?

Regarding test-lab accreditation:
How important is this? Are test-reports issued from non-accredited test-houses acceptable? Will they (likely) be subject to additional scrutiny? If so, what measures can/should be in place to anticipate the extra scrutiny?

 

[yodon]

My understanding is that the CB scheme just expands testing to cover country-specific deviations.

I've never used a non-accredited lab so I don't know what additional scrutiny would be applied. Extrapolating from other experiences, though, it could be anything from rejected to requiring an audit of the facility to additional paperwork (e.g., calibration data for all the equipment used, resumes / training records for testers, etc.). Seems like an awfully big risk.

 

[Mark Meer]

My understanding is that the CB scheme just expands testing to cover country-specific deviations.

If this is the case, it seems odd that there's no option to choose which deviations to apply. I could be mistaken, but as far as the quotes I get, it appears the CB scheme option is either all-or-none.

I guess the question is then: what is the regulatory impact? Will an IEC 60601-1 test report be rejected by a regulatory body because it was not by CB scheme (and hence didn't cover their country-specific deviations)? If so, is it not possible to cover these deviations without the significant added cost of CB scheme?

Curious: which country-specific deviations does the CB-scheme cover?

I've never used a non-accredited lab so I don't know what additional scrutiny would be applied. Extrapolating from other experiences, though, it could be anything from rejected to requiring an audit of the facility to additional paperwork (e.g., calibration data for all the equipment used, resumes / training records for testers, etc.). Seems like an awfully big risk.

Yes, this was my concern. Seems a shame though. A local engineer just bought an EMC test chamber, but is not yet accredited. Offering big discounts (compared with the "big guys") while he tries to get his business off the ground. I trust the guy's competency, but not sure if it's worth the potential headaches later on from regulators/auditors.

 

[yodon]

That's a good question about whether you can exclude specific country deviations. If I recall, the added testing for deviations wasn't a whole lot of extra effort. In one instance, I do believe I was able to pare down testing to just EU and N. America. It's worth a chat with an NRTL.

 

[Mark Meer]

That's a good question about whether you can exclude specific country deviations. If I recall, the added testing for deviations wasn't a whole lot of extra effort. In one instance, I do believe I was able to pare down testing to just EU and N. America. It's worth a chat with an NRTL.

It's not a matter of "a whole lot of extra effort", as I don't think the deviations are that substantial. It's a matter of extra cost for CB Scheme, and whether it's worth it. As I say, all the quotes I've received give a fairly substantial price tag to the CB option.

If you DON'T go with the CB Scheme option, does it impact the recognition by, for example, the US FDA, Health Canada, or a European NB? If not, I can't see that it's worth it...