DIN EN ISO 11137-2:2015-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Hardcopy , PDF
08-01-2023
English, German
11-01-2015
National foreword
National Annex NA (informative) - Bibliography
Foreword
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
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