PRICES include / exclude VAT
Sponsored link
download between 0-24 hoursReleased: 2019
ISO 11737-2
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Format
Availability
Price and currency
English PDF
Immediate download
92.63 USD
English Hardcopy
In stock
92.63 USD
French PDF
Immediate download
92.63 USD
French Hardcopy
In stock
92.63 USD
Standard´s number: | ISO 11737-2 |
Pages: | 16 |
Edition: | 3 |
Released: | 2019 |
DESCRIPTION
ISO 11737-2
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 which has been 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), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
Customers who bought this item also bought
BS EN ISO 10993-10:2013
Biological evaluation of medical devices Tests for irritation and skin sensitization
Biological evaluation of medical devices Tests for irritation and skin sensitization
Released: 2014-02-28
English Secure PDF
Immediate download
362.01 USD
English Hardcopy
In stock
362.01 USD
English PDF
Immediate download
92.63 USD
English Hardcopy
In stock
92.63 USD
BS EN ISO 3826-1:2019
Plastics collapsible containers for human blood and blood components Conventional containers
Plastics collapsible containers for human blood and blood components Conventional containers
Released: 2019-10-25
English Secure PDF
Immediate download
281.85 USD
English Hardcopy
In stock
281.85 USD
English PDF
Immediate download
40.00 USD
English Hardcopy
In stock
40.00 USD
French PDF
Immediate download
40.00 USD
French Hardcopy
In stock
40.00 USD