Cleanliness Specifications that apply to non-sterile medical devices

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M

MIREGMGR

#12
for parts provided non-sterile, we prescribe steam sterilization (with specific cycle times).
Have you reviewed:

EN ISO 14937:2000 "Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices"

EN ISO 17664:2004 "Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices"
 
M

MIREGMGR

#13
Probably, you could have a look at ISO 11137
It's easy to confuse the two numbers, at least for me, but perhaps you also might want to review:

EN ISO 11737-1:2006 "Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products"
 
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