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BS EN ISO 11138-5:2017

Current
Current

The latest, up-to-date edition.

Sterilization of health care products. Biological indicators Biological indicators for low-temperature steam and formaldehyde sterilization processes
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2017

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

NOTE1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO14937 .

NOTE2 Requirements for work place safety can be provided by national or regional regulations.

Committee
CH/198
DevelopmentNote
Supersedes BS EN 866-5 and 04/30078111 DC (08/2006) Supersedes 15/30321514 DC. (04/2017)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results

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