SS-EN-ISO-11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)

SS-EN-ISO-11138-1 - 2017 EDITION - CURRENT
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This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.This document specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.NOTE National or regional regulations can apply.This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

To find similar documents by classification:

11.080 (Sterilization and disinfection)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.080.20 (Disinfectants and antiseptics Chemicals for industrial and domestic disinfection purposes, see 71.100.35)


Medical devices

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Designation Name

SS-EN ISO 11138-1:2017

Revision Level

2017 EDITION

Status

Current

Publication Date

April 5, 2017

Language(s)

English

Page Count

56

International Equivalent

EN ISO 11138-1:2017(IDT); ISO 11138-1:2017(IDT)