I.S. EN ISO 11737-1:2018&LC:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
21-07-2021
English
01-01-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of products
6 Methods of determination and microbial characterization of
bioburden
7 Validation of the method for determining bioburden
8 Routine determination of bioburden and interpretation of
data
9 Maintenance of the method for determining bioburden
Annex A (informative) - Guidance on the determination of
a population of microorganisms on products
Annex B (informative) - Guidance on methods to determine
bioburden
Annex C (informative) - Validation of bioburden recovery efficiency
Annex D (informative) - Typical assignment of responsibilities
Bibliography
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
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