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Participant

Join Date: Apr 2006
Posts: 4

Orthopedic Devices

04/06/2006 8:24 AM

To produce orthopedic implants

1. What standards apply - ISO, ASTM, etc.?
2. What is the sequence of standards that apply to materials for packaging or sterilization?

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Power-User

Join Date: May 2005
Posts: 161
Good Answers: 2
#1

FDA

04/06/2006 9:24 AM

If you have to ask this question, you can begin you long education into the realm of heavy government (USA) regulations by reading 21 CFR Part 11, just to get you started. Have fun and Happy Reading!!!!

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