Name:
DANSK DSF/PREN ISO 11737-2 PDF

Published Date:

Status:
[ Draft-Obsolete ]

Description:

Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018)

Publisher:
Dansk Standard

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

DRAFT * SAME AS ISO DIS 11737-2 * W/D NO S/S

1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), and NOTE 1 – The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) culturing of biological indicators or inoculated products. NOTE 2 – Guidance on culturing biological indicators is included in ISO 11138-7[5].

Edition :	18
File Size :	1 file , 1.2 MB
Number of Pages :	30
Product Code(s) :	DSF-021, DSF-021

History

DANSK DSF/PREN ISO 11737-2

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Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018)

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DANSK DSF/FPREN ISO 11737-2

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Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/FDIS 11737-2:2019)

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