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Home > Archive > Electrical code Compliance > February 2007 > When do IEC 60601-1-4 apply?
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When do IEC 60601-1-4 apply?
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| Gisly@NNL 2007-01-08, 9:25 am |
| This is a question regarding the 60601 series of standars for medical
devices.
Regarding software incorporated into an medical device:
In the third edition of 60601 an full life cycle documentation (clause
14) is not required if the software:
*the PESS (software) provides no basic safety or essential
performance; or
*the application of ISO 14971 demonstrates that the failure of the
PESS does not lead to an unacceptable risk.
This exludes the need to furfill 60601-1-4/Clause 14 for a lot of
software used (including ours)
But I can't find these exceptions in the second edition of 60601-1, nor
the 60601-1-4. Since the third edition of 60601-1 is not accepted by
FDA/EU yet, does this mean that all software used in an medical
device/system must apply to 60601-1-4 to furfill the requirements, or
can I still prove trough our risk management that this is not necessary
since the software has no hazards related to it's functions?
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| mmantunes@gmail.com 2007-02-28, 8:25 pm |
| On 8 jan, 09:44, "Gisly@NNL" <s...@nordicneurolab.com> wrote:
> This is a question regarding the 60601 series of standars for medical
> devices.
>
> Regarding software incorporated into an medical device:
>
> In the third edition of 60601 an full life cycle documentation (clause
> 14) is not required if the software:
>
> *the PESS (software) provides no basic safety or essential
> performance; or
> *the application of ISO 14971 demonstrates that the failure of the
> PESS does not lead to an unacceptable risk.
>
> This exludes the need to furfill 60601-1-4/Clause 14 for a lot of
> software used (including ours)
>
> But I can't find these exceptions in the second edition of 60601-1, nor
> the 60601-1-4. Since the third edition of 60601-1 is not accepted by
> FDA/EU yet, does this mean that all software used in an medical
> device/system must apply to 60601-1-4 to furfill the requirements, or
> can I still prove trough our risk management that this is not necessary
> since the software has no hazards related to it's functions?
You can use you risk management to show that the risks related to
software are acceptable and that you do not need to comply to IEC
60601-1-4. Just remember that standards are means of risk control,
when you use risk management according to ISO 14971 you have to be
worried about risks and hazards, it doesn=B4t matter awhat document you
use - but surely using a standard is the easiest way to show that some
risks are acceptable.
--
Best regards,
Marcelo de Moraes Antunes - mantunes@ipt.br
Medical Electrical Equipment DIvision
Electrical and Optical Equipment LAboratory -
Institute for Technological Research - IPT - Sao Paulo - Brazil
Fone +55 (11) 3767-4820 Fax +55 (11)3767-4007
Medical Electrical Information Website: http://www.electromedicalinfo.com/
MSN: marcelo_antunes@hotmail.com
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