BS EN ISO 11737-2:2020
$167.15
Sterilization of health care products. Microbiological methods – Tests of sterility performed in the definition, validation and maintenance of a sterilization process
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 36 |
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:
-
sterility testing for routine release of product that has been subjected to a sterilization process,
-
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.
-
test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
-
culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138‑7.
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:
-
sterility testing for routine release of product that has been subjected to a sterilization process,
-
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.
-
test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
-
culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138‑7.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 5 | Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices [OJ L 189] aimed to be covered |
| 7 | Annex ZB (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be covered |
| 9 | Annex ZC (informative)Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L 331] aimed to be covered |
| 11 | Annex ZD(informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered |
| 13 | Annex ZE(informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered |
| 16 | Foreword |
| 18 | Introduction |
| 19 | 1 Scope 2 Normative references 3 Terms and definitions |
| 21 | 4 General |
| 22 | 5 Selection of product 5.1 General 5.2 Sample item portion (SIP) |
| 23 | 5.3 Packaging of product and sample item portions 6 Methods for performing tests of sterility |
| 24 | 7 Assessment of the method for performing tests of sterility 8 Maintenance of the method for performing tests of sterility |
| 25 | Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process |
| 32 | Annex B (informative) Typical assignment of responsibilities |
| 33 | Bibliography |
