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CSA Z17665-1 : 2009 : FR

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

04-27-2014

Language(s)

English

Published date

01-01-2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
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 (informative) - Guidance
Annex B (informative) - Process definition based on
        inactivation of the microbial population in its
        natural state (bioburden-based method)
Annex C (informative) - Process definition based on the
        inactivation of a reference microorganism and a
        knowledge of bioburden on product items to be
        sterilized (combined bioburden/biological
        indicator based method)
Annex D (informative) - Conservative process definition
        based on inactivation of reference microorganisms
        (overkill method)
Annex E (informative) - Operating cycles
Bibliography

Describes requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

DevelopmentNote
Supersedes CSA ISO 11134. (04/2009)
DocumentType
Standard
Pages
64
ProductNote
Reconfirmed F
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

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
EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
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
EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
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 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
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 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN 13060:2014 Small steam sterilizers
EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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