Sterilization of health care products — Radiation — Part 4: Guidance on process control
Scope:
ISO 11137-4 provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
Project need:
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