Skip to main content
Back

EVS-EN ISO 11138-1:2017

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

General information

Valid from 18.04.2017
Base Documents
ISO 11138-1:2017; EN ISO 11138-1:2017
Directives or regulations
None

Standard history

Status
Date
Type
Name
18.04.2017
Main
07.09.2006
Main
ISO 11119-1 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators to be used in the validation and routine monitoring of sterilization processes. It includes inoculated carriers and suspensions and their components.

It specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for specified processes are provided in the relevant parts of ISO 11138.

ISO 11119-1 does not apply to microbiological test systems for processes that rely on the physical removal of microorganisms. This means filtration processes or processes that combine physical or mechanical removal with microbiological inactivation, such as the use of washer disinfectors or flushing and steaming of pipelines. ISO 11119-1, however, can contain elements relevant to such microbiological test systems. The text of ISO 11138-1:2017 has been approved in Europe as EN ISO 11138-1:2017 without any changes.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 11138-2:2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
Newest version Valid from 18.04.2017
Main

EVS-EN ISO 11138-3:2017

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
Newest version Valid from 18.04.2017
Main

EVS-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)
Newest version Valid from 02.06.2020
Main

EVS-EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Newest version Valid from 18.06.2018