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Cleaning of Active implantable medical Device (as per ISO)

mk2000 (Mechanical)
19 Aug 04 10:26
Dear all

I am involved in writing specification for a production facility for a Active implantable medical device. I have 3 questions:

1. Can some one help me in finding any ISO or other standards that specify as to how "clean" (not non-toxic or non-bio hazardous) does the medical device need to be?

2. And does the production facility/process need to be compliant with a particular standard in term of cleanness?

3. does the device need to be manufactured and assembled in a clean room environment? Can someone tell me when would one specify clean room environment for a medical device?


Regards
sigmanut (Electrical)
15 Oct 04 12:16
Any  results yet?  
ISO does not have a standard. In ISO you write the standard you want to perform to and it becomes your standard. However, FDA does have standards based on the Code of Federal Regulations (CFR) 820.1 and the GMP regulation. I think sections CP7382.830 and 7382.830A may  be of help on the GMP part since it is about sterilization

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