ANSI/AAMI/ISO 11137-1:2006(R2015) & A1:2013 & A2:2019
Current
The latest, up-to-date edition.
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
English
01-05-2019
Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| ISBN |
1-57020-253-2
|
| Pages |
11
|
| ProductNote |
THIS STANDARD REFERS:EN 556-1,ANSI/AAMI ST67:
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
| Standards | Relationship |
| ISO 11137-1:2006/Amd 2:2018 | Identical |
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