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NS EN ISO 11737-2 : 2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
Withdrawn date

06-15-2020

Published date

01-12-2013

1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection and preparation of product units for
      testing
6 Tests of sterility
7 Assessment of method for test of sterility
Annex A (informative) Guidance on tests of sterility
                      performed in validation of a
                      sterilization process
Bibliography

Establishes the general requirements for tests on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Withdrawn
SupersededBy

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