I.S. EN ISO 11737-2:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
Hardcopy , PDF
11-30-2020
English
01-01-2009
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (informative) Guidance on tests of sterility performed
in validation and maintenance of a sterilization process
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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