mk2000
Mechanical
- Nov 5, 2001
- 92
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
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