CSA Z11135-1 : 2009 : R2014

Superseded

STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

01-11-2015

Language(s)

English

Published date

01-01-2014

Publisher

Canadian Standards Association

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (normative) - Determination of lethal rate of the
        sterilization process - Biological indicator/bioburden
        approach
Annex B (normative) - Conservative determination of lethal
        rate of the sterilization process - Overkill approach
Annex C (informative) - General guidance
Bibliography

Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

DevelopmentNote	Supersedes CSA ISO 11135. (04/2009)
DocumentType	Standard
Pages	60
ProductNote	Reconfirmed EN
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA Z11135 : 2015
Supersedes	CSA Z11135-1 :2009 CSA Z11135-1 : 2009 : FR

IEC 61010-2-040:2015	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
CSA Z314.2 : 2009	EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
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 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ISO 11138-2:2017	Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 14001:2015	Environmental management systems — Requirements with guidance for use
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9001:2015	Quality management systems — Requirements
ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 22442-3:2007	Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO/IEC 90003:2014	Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
IEC 61010-1:2010+AMD1:2016 CSV	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 14040:2006	Environmental management Life cycle assessment Principles and framework
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices