ISO 11137:1995
Withdrawn
View Superseded by
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Hardcopy , PDF
03-09-1995
04-12-2019
Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
61
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| SAC GB 18280 : 2000 | Identical |
| AAMI TIR27 : 1ED 2001 | Identical |
| AAMI ISO 11137 : 94 AMD 1 2002 | Identical |
| AS ISO 11137-2002 | Identical |
| AAMI TIR17 : 2008 | Identical |
| GOST R ISO 11137 : 2000 | Identical |
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