Software embedded in a Medical Device

D

DuttonT

#1
We will have a counter as part of a medical device. Counter is a module that is run by software. The supplier does not have documentation statiing the test results of any testing. Just that the product has been in manufacturing for more than 5 years. I am following 60601-1-4:1996 for compliance. I am looking to do the following (will this be in compliance)

“verify” at multiple points. For example, the design is verified against the requirements and software is verified against the design. Test that system-level requirements were met by running a system verification test of the completed product.
Validation, by “real” end users (in controlled settings) and only done on the final product
 
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D

DuttonT

#2
Ref the above post;

Our PEM will not have any effect on human safety. The software in the device will be an essentail function of the device, however, if device fails will not cause injury or death. Will we still need to comply with 60601-1-4?

Thank you in advance
 

Marcelo

Inactive Registered Visitor
#3
If IEC 60601-1-4 was not used doing design, the only real way to comply is to "redesign" or retrofit the safety in the design. That´s because the only way to guarantee the safety of the software is to perform risk management during the design. If yoou do it in the final software, even if you do "verifications and validations", you will surely miss a lot of things.

Our PEM will not have any effect on human safety. The software in the device will be an essentail function of the device, however, if device fails will not cause injury or death. Will we still need to comply with 60601-1-4?
IEC 60601-1-4 is not very clear on when it should be applied. In the third edition, it´s more explicit (and remember the third edition incorporate IEC 60601-1-4).

The requirements of this clause shall apply to PEMS unless:

the PESS 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.
So, if you demonstrate in your risk management that the failure of the PESS does not lead to an unnaceptable risk, you would not need to apply the programmable medical electrical systems safety requirements of IEC 60601-1 third edition. You could also use the same rationale for IEC 60601-1-4.

BUT, note that Injury or death are classifications of the severity of harm of a risk, not the hazard or hazardous situations which might develop in a medical device, and, as the manufacturer defines wht is unneceptable risk, it can be that not only these injury or death are unnaceptable.

As an example, there´s a lot of devices for which the situations of not delivering it´s output, even if with no injury or death, is an unnaceptable risk.
 
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