Customer Support: +44 (0)203 327 3140

Login to i2i Subscription Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

CSA Z17665-2:09 (R2019)

Current
Current

The latest, up-to-date edition.

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2009

Publisher

Canadian Standards Association

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) - Evaluation of a sterilization
        process primarily based on the measurement
        of physical parameters
Annex B (informative) - Evaluation of a sterilization
        process primarily based on biological inactivation
        and an accompanying mechanical air removal procedure
Annex C (informative) - Temperature and pressure of
        saturated steam for use in moist heat sterilization
Annex D (informative) - Special considerations for health
        care settings
Annex E (informative) - Index of normative clauses/subclauses
        of ISO 17665-1 and cited references or related
        guidance given in ISO 17665-1 and ISO/TS 17665-2
Bibliography

CSA Preface This is the first edition of CAN/CSA-Z17665-2, Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 17665-2 (first edition, 2009-01-15). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E. NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.

CSA Preface This is the first edition of CAN/CSA-Z17665-2, Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 17665-2 (first edition, 2009-01-15). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E. NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.

DocumentType
Standard
ISBN
978-1-55491-143
Pages
64
ProductNote
Reconfirmed F
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO/TS 17665-2:2009 Identical

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 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
BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
BS EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
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
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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
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/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
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/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 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
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

View more information
£158.62
Excluding VAT
GBP
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
PDF - French
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us