ISO 11138:2017
ISO 11138:2017 Sterilization of health care products – Biological indicators – Part 1: General requirements
CDN $312.00
Description
Ôªø
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.
Edition
3
Published Date
2017-03-03
Status
PUBLISHED
Pages
41
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
Ôªø
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 13666:2019 Ophthalmic optics – Spectacle lenses – Vocabulary
CDN $76.00 Add to cart -
ISO 15416:2025 Automatic identification and data capture techniques – Bar code print quality test specification – Linear symbols
CDN $312.00 Add to cart -
ISO 20560:2024 Safety information for the content of piping systems and tanks – Part 1: Piping systems
CDN $233.00 Add to cart -
ISO 7176:2007 Wheelchairs – Part 26: Vocabulary
CDN $312.00 Add to cart
