Orthopedic Devices and Implants Manufacturing Cleanliness Requirements

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yana prus

probably you mean ISO 11737-1:2006 
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products. It can also be
ISO 11137-1:2006(en) Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
 
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