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sklademVydáno: 2013
ISO 11137-2:2013
ISO 11137-2:2013-Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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Anglicky PDF
Immediate download
242.41 €
Francouzsky PDF
Immediate download
242.41 €
Anglicky Hardcopy
In stock
242.41 €
Francouzsky Hardcopy
In stock
242.41 €
| Označení normy: | ISO 11137-2:2013 |
| Počet stran: | 68 |
| Vydání: | 3 |
| Vydáno: | 2013 |
| Počet stran (Anglicky): | 68 |
| Počet stran (Francouzsky): | 68 |
DESCRIPTION
ISO 11137-2:2013
ISO 11137-2:2013 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 sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.