AAMI - TIR11137-4
Sterilization of health care products—Radiation—Part 4: Guidance on process control
active, Most Current
| Organization: | AAMI |
| Publication Date: | 1 January 2022 |
| Status: | active |
| Page Count: | 67 |
scope:
This document provides additional guidance to that given in the International Organization for Standardization (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.
Document History
TIR11137-4
January 1, 2022
Sterilization of health care products—Radiation—Part 4: Guidance on process control
This document provides additional guidance to that given in the International Organization for Standardization (ISO) 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and...
January 1, 2022
Sterilization of health care products—Radiation—Part 4: Guidance on process control
This document provides additional guidance to that given in the International Organization for Standardization (ISO) 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and...