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thaly7 - 2010
I just wanted to say thank you, your input has been really helpful and this is exactly what I was looking for.
Ft. Lauderdale, FL
Ft. Lauderdale, FL
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MIREGMGR
Contents privileged, or shareable?
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Mike Schmidt
I realize that the size of the amendment may be intimidating :mg: but for those applying the standard, the content will be a reason to celebrate (so "gulp" some champaign!
). In many cases, the changes are intended to stop what can only be called outright abuse by certification bodies . For example, the intent of 4.2 was never to require on-site audits of risk management processes nor to require that the post production requirements of 14971 be met to comply with 60601-1. The original text of the compliance statement said "by inspection of the risk management file". This has been clarified. A similar change was made to prevent manufacturers from being required to have "fire enclosures" for most equipment (an interpretation sheet was issued to clarify this temporarily) and to raise the energy threshold where a potential risk of ignition exists from 15 W to 100VA (in a given circuit). There are some new requirements such as the new clause 18 which addresses software only medical devices (the scope was modified to allow this inclusion). This should prove helpful (where applicable) because (assuming harmonization/recognition) it will standardize what's required for such products.
Overall, the Amendment will help make application of the standard closer to the intent and help prevent "manufacturer abuse"
by certifiers who consider the 3rd Edition a revenue generation opportunity!
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Mike Schmidt
The problem is that the drafts are copyrighted and can only be shared (exact wording) through member National Committees. The IEC pays for its operation from National Committee dues. Besides, the only way to have input is by joining your national committee.
Well, just putting together these last posts and the thread as a whole, one of the problems is that Amendment 1 is scheduled to be published on the second quarter of 2012 by iEC...which means that, when EN 60601-1 is harmonized in europe (june 2012 for equipment with no particular standards) amendment 1 won´t have been harmonized yet. This may raise some concerns. Hopefully some solution may be found until then.
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Mike Schmidt
I don't want anyone to think that the 3rd Edition is unusable or the requirements as they stand are unreasonable. The real problems it does have were created by either poor wording by those of us who wrote it (although we spent nearly 10 years trying to avoid doing so) or certifiers who have intentionally misread (I say intentional because they have continued to hold the same position even after being corrected by the authors) what is required. The most significant of these have been addressed by the interpretation sheets that were published by IEC/SC 62A or are clearly explained in the original text (if you aren't pushing an agenda).
Between now and the point where the Amendment is published, manufacturers should read the interpretations, use common sense and above all read the rationale. If a certifier insists on what seems an unreasonable or unjustified interpretation, push back and if they aren't reasonable hire another certifier! Most of all, don't ever forget that 99% of the test engineers you deal with have no more knowledge about any given standard than you do (few were actually there when the requirements were written). They may have more experience reading standards (generally), but that's it.
Most importantly, when reading any medical device standard: understand the hazard and risk being addressed first. The only reaon for applying a requirement is to lower the risk associated with the issue being addressed to acceptable levels (14971 defines this as the purpose of "consensus standards"). If the requirement (or interpretation of it you are hearing) doesn't address a legitimate safety concern it either doesn't apply or you've misunderstood the requirement. Regarding test houses, ask them to justify their interpretations in those terms: "what's the harm being prevented?"
This isn't rocket science.
Between now and the point where the Amendment is published, manufacturers should read the interpretations, use common sense and above all read the rationale. If a certifier insists on what seems an unreasonable or unjustified interpretation, push back and if they aren't reasonable hire another certifier! Most of all, don't ever forget that 99% of the test engineers you deal with have no more knowledge about any given standard than you do (few were actually there when the requirements were written). They may have more experience reading standards (generally), but that's it.
Most importantly, when reading any medical device standard: understand the hazard and risk being addressed first. The only reaon for applying a requirement is to lower the risk associated with the issue being addressed to acceptable levels (14971 defines this as the purpose of "consensus standards"). If the requirement (or interpretation of it you are hearing) doesn't address a legitimate safety concern it either doesn't apply or you've misunderstood the requirement. Regarding test houses, ask them to justify their interpretations in those terms: "what's the harm being prevented?"
This isn't rocket science.
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