ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]

Body: ISO
Number: ISO 11137-1
Editions: 2006、2025
FDA recognition no.: 14-611
FDA recognition no.: 14-528

Scope

Complete standard

Scope source: FDA 认可共识标准库

Laboratories covering this standard

No laboratory recorded yet.

Standard text: The text of this standard is copyrighted. This site does not provide the full text. Obtain it from the official channel: ISO / IEC 国际标准