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Information document
Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"
IMDRF Code
IMDRF/MC/N38
Published date
IMDRF code:
IMDRF/MC/N38 FINAL:2015
Published date:
Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"