Sterilization of health care products — Biological indicators — Part 1: General requirements
Also Known As:
SKU162712433
Published by
Canadian Standards Association
CSA
Publication Date2017-08-01
Pages CountPages61
This is the second edition of CAN/CSA-ISO 11138-1, Sterilization of health care products - Biological indicators - Part 1: General requirements, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-1 (third edition, 2017-03). It supersedes the previous edition published in 2007 as CAN/CSA-Z11138-1 (adopted ISO 11138-1:2006).
Scope
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.
Scope
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.
Details
| Edition | 2 |
| ICS Codes | 11.080.01 - Sterilization and disinfection in general |
| Language(s) | English |
| ISBN | 9781488311741 |
| File Size | 3.3 MB |
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