ONORM EN ISO 11737-1 : 2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
21-03-2019
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control of
nonconforming product
5 Selection of product
5.1 General
5.2 Sample item portion (SIP)
6 Methods of determination and microbial characterization
of bioburden
6.1 Determination of bioburden
6.2 Microbial characterization of bioburden
7 Validation of method for determining bioburden
8 Routine determination of bioburden and interpretation of
data
9 Maintenance of the method of determination of bioburden
9.1 Changes to the product and/or manufacturing process
9.2 Changes to the method of determination of bioburden
9.3 Revalidation of the method of determination of bioburden
Annex A (informative) Guidance on determination of a population
of microorganisms on product
Annex B (informative) Guidance on methods of determination of
bioburden
Annex C (informative) Validation of bioburden methods
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directives 90/385/EEC concerning
active implantable medical devices,
93/42/EEC concerning medical devices and
98/79/EC concerning in vitro diagnostic
medical devices
Bibliography
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