Standard Swedish standard · SS-EN ISO 11138-7:2019

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

Status: Valid

Scope
This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. It is not applicable to liquid immersion sterilization processes.

Subjects

General (11.040.01) Sterilization and disinfection in general (11.080.01) General (11.120.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80011454

Edition: 1

Approved: 4/24/2019

No of pages: 80

Replaces: SS-EN ISO 14161:2009