ISO 11737-2:1998 PDF

ISO 11737-2:1998 PDF

Name:
ISO 11737-2:1998 PDF

Published Date:
07/01/1998

Status:
[ Withdrawn ]

Description:

Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process

Publisher:
International Organization for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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Choose Document Language:
$24
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This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which 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 performed when validating a sterilization process.

This part of ISO 11737 is not applicable to:

  • sterility testing for routine release of product that has been subjected to a sterilization process;
  • performance of a pharmacopoeial test for sterility; or
  • culturing of biological indicators, including inoculated products.

File Size : 1 file , 60 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 13
Published : 07/01/1998

History

ISO 11737-2:2019
Published Date: 12/01/2019
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
$37.2
ISO 11737-2:2009
Published Date: 11/15/2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
$30.9
ISO 11737-2:1998
Published Date: 07/01/1998
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
$24

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ISO 11737-1:2018
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Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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ISO 11737-3:2004
Published Date: 07/01/2004
Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
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