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国际标准
EN ISO 11137-2-2013 欧盟标准
作者：未知发布时间2025-04-14
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
4 Definition and maintenance of product families for dose
setting, dose substantiation, and sterilization
dose auditing
5 Selection and testing of product for establishing the
sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive information
from incremental dosing to determine an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 90/385/EEC on active implantable
medical devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 98/79/EC on in vitro diagnostic
medical devices
Bibliography
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
4 Definition and maintenance of product families for dose
setting, dose substantiation, and sterilization
dose auditing
5 Selection and testing of product for establishing the
sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive information
from incremental dosing to determine an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 90/385/EEC on active implantable
medical devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 98/79/EC on in vitro diagnostic
medical devices
Bibliography
标准简介：Describes 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].
技术开发：