ISO / ASTM standards for Sampling Plans for Medical Devices

mpfizer

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#1
Hi,

Are there any ISO / ASTM standards for sampling plans for medical devices?

If not which sampling plan would be best suited for orthopaedic implant manufacturing .. any suggestions.

Thanks

michelle
 
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locutus

#2
mpfizer there are not any specific sampling plan to the medical device industry, however most use either ANSI Z1.4 or Z1.9, though the better you should look at is ISO 2859 series. In most of my experience medical device companies, even those making implants, use ANSI Z1.4 or ISO 2859. Read ISO 2859-10 that should give you an idea of which one of the series would be appropriate for what and how you are making the product.
 
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