UNE EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Esterilización de productos para la salud. Métodos microbiológicos. Parte 2: Ensayos de esterilidad efectuados para la definición, validación y mantenimiento de un proceso de esterilización. (ISO 11737-2:2019).
| Standard number: | UNE EN ISO 11737-2:2020 |
| Pages: | 36 |
| Released: | 2020-12-16 |
| Status: | Standard |
| Pages (Spanish): | 39 |
UNE EN ISO 11737-2:2020
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].