ISO 11138-1:2017
Current
The latest, up-to-date edition.
Sterilization of health care products — Biological indicators — Part 1: General requirements
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
03-03-2017
ISO 11138-1:2017 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.
ISO 11138-1:2017 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.
ISO 11138-1:2017 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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11138-1. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
41
|
| ProductNote |
THIS STANDARD ALSO CONTAIN FRENCH LANGUAGE FOR THE YEAR 2018-02
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11138-1:2017-07 | Identical |
| NF EN ISO 11138-1 : 2017 | Identical |
| NEN EN ISO 11138-1 : 2017 | Identical |
| NS EN ISO 11138-1 : 2017 | Identical |
| I.S. EN ISO 11138-1:2017 | Identical |
| PN EN ISO 11138-1 : 2017 | Identical |
| SS-EN ISO 11138-1 : 2017 | Identical |
| BS EN ISO 11138-1:2017 | Identical |
| EN ISO 11138-1:2017 | Identical |
| ANSI/AAMI/ISO 11138-1:2017 | Identical |
| CAN/CSA-ISO 11138-1:17 (R2022) | Identical |
| DIN EN ISO 11138-1:2015-10 (Draft) | Identical |
| ABNT NBR ISO 11138-1:2021 | Identical |
| ANSI/AAMI/ISO 11138-1:2017(R2024) | Identical |
| AAMI ST59 : 1ED 99 | Identical |
| NBR ISO 11138-1 : 2016 | Identical |
| GOST ISO 11138-1 : 2012 | Identical |
| SAC GB 18281.1 : 2000 | Identical |
| UNE-EN ISO 11138-1:2017 | Identical |
| GOST R ISO 11138-1 : 2000 ERRATA 2001 | Identical |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.