BS EN ISO 11137-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Hardcopy , PDF
04-21-2023
English
06-30-2015
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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