Revision of ISO 16142 - Clause on use of standards in the medical device life-cycle

Marcelo

Inactive Registered Visitor
#1
Hello all

ISO/TR 16142:2006 - Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices is being revised (due the revision of the GHTF essential principles).

I suggested adding a clause on "Standards in the medical device life-cycle" to explain a little how to use standards during all phased of a medical device life. This was initially based on the attached image. This was prompted by the experience that some manufacturers still have difficult understanding why and how standards could be used for their products.

Right now theclause has the following subparts:

4.3 Standards in the medical device life-cycle
4.3.1. Risk management and essential principles
4.3.2. The medical device lifecycle
4.3.3. Use of standards during medical device design and development planning
4.3.4. Use of standards during device design including testing and validation
4.3.5. Use of standards during manufacturing
4.3.6. Use of standards during regulatory approval
4.3.7. Use of standards during post-production including device use and post-market surveillance
4.3.8. Use of standards during device end of life

I wanted to get some input from other Covers on this, what they think should be explained, any additional topic, etc.
 

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Stijloor

Staff member
Super Moderator
#2
Re: Revision of ISO 16142 - Clause on use of standards in the medical device life-cyc

A Quick Bump!

Can Covers respond?

Thank you very much!!
 
U

UncleCrazyHorse

#3
Re: Revision of ISO 16142 - Clause on use of standards in the medical device life-cyc

I'm extremely late to this party. Marcelo, I see that your suggestion was incorporated in section 5.4 of the 2016 revision! Kudos! And, as a recent user of the standard, I thank you for that!
:thanks:
It has eliminated a lot of churn on both the Which Ones? and the When? to apply the various standards within our product development process.
Cheers!
 

Marcelo

Inactive Registered Visitor
#4
Re: Revision of ISO 16142 - Clause on use of standards in the medical device life-cyc

Great that it's helping. Thanks!

I'm extremely late to this party. Marcelo, I see that your suggestion was incorporated in section 5.4 of the 2016 revision! Kudos! And, as a recent user of the standard, I thank you for that!
:thanks:
It has eliminated a lot of churn on both the Which Ones? and the When? to apply the various standards within our product development process.
Cheers!
 
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