SS ISO 11137-2:2019
Sterilisation of health care products – Radiation – Part 2: Establishing the sterilisation dose
OVERVIEW
Specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilisation dose to achieve a sterility assurance level, SAL, of 10-6. Also specifies methods of sterilisation dose audit used to demonstrate the continued effectiveness of the sterilisation dose.
Defines product families for sterilisation dose establishment and sterilisation dose audit.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2019 |
| No. of Pages | 90 |
| ICS Classification | 11.080.01 Sterilization and disinfection in general |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 11137-2 : 2013 IDT |