IMDRF/MC/N38: 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"
Summary
Information document
This document has been developed by the International Medical Device Regulators Forum (IMDRF) — a voluntary group of medical device regulators from around the world who work together to accelerate international convergence in medical device regulation.
Document Details
- Document Code: IMDRF/MC/N38
- Type: Information document
- Issuing Authority: IMDRF
- Date: 2015-10-02
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Source: International Medical Device Regulators Forum (IMDRF). This content is provided for informational purposes. Always refer to the official IMDRF document for the most current version.
Document Details
Document IDIMDRF/MC/N38
TypeIMDRF Information document
AuthorityIMDRF
Publication Date2015-10-02