Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (Adopted ISO 11138-5:2017, second edition, 2017-03)

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2017

Publisher

Canadian Standards Association

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of resistance
        to low-temperature steam and formaldehyde
Annex B (informative) - Rationale for the liquid-phase test
        method for low-temperature steam and formaldehyde
        biological indicators
Bibliography

This is the first edition of CAN/CSA-ISO 11138-5, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-5 (second edition, 2017-03). Scope 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. NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

DocumentType	Standard
ISBN	978-1-4883-1188-8
Pages	0
PublisherName	Canadian Standards Association
Status	Current

Standards	Relationship
ISO 11138-5:2017	Identical

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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CAN/CSA-ISO 11138-5:17

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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