CSA ISO 11139:19 (R2024)
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards (Adopted ISO 11139:2018, first edition, 2018-08)
English, French
01-01-2019
12-09-2025
CSA Preface This is the first edition of CSA ISO 11139, Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11139 (first edition, 2018-08). It replaces CAN/CSA-ISO/TS 11139:18 (adopted ISO/TS 11139:2006), Sterilization of health care products — Vocabulary. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope This document defines terms in the field of the sterilization of health care products including related equipment and processes.
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Standard
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| ISBN |
978-1-4883-2352-2
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| Pages |
0
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| ProductNote |
THIS STANDARD ALSO REFERS TO ISO/TS WD 11137-4:2017, ISO/CD 11138‑8:2016, ISO/FDIS 11607‑2:2018, ISO/FDIS 11607‑1:2018, ISO/FDIS 15883‑4:2018, ISO/CD 15883‑5:2017, ISO/DTS 19572:2018, ISO/DTS 21387:2018, ISO/FDIS 25424:2018, GHTF/SG1/N055 :2009, GHTF/SG3/N99-10:2004, PF40/1083-1:2014, ISO 11140‑4, ISO 11140‑5 . New child AMD 1 2025 is now added
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| PublisherName |
Canadian Standards Association
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| Status |
Withdrawn
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CSA Preface This is the first edition of CSA ISO 11139, Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards , which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11139 (first edition, 2018-08). It replaces CAN/CSA-ISO/TS 11139:18 (adopted ISO/TS 11139:2006), Sterilization of health care products — Vocabulary. For brevity, this Standard will be referred to as “CSA ISO 11139” throughout. This Standard was reviewed for Canadian adoption by the SCC Mirror Committee to ISO/TC 198, under the jurisdiction of the CSA Technical Committee on Medical Device Reprocessing and the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope This document defines terms in the field of the sterilization of health care products including related equipment and processes.
| Standards | Relationship |
| ISO 11139:2018 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| ISO/TS 13004:2013 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| 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 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| ISO 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| ISO 15883-6:2011 | Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 15883-3:2006 | Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers |
| EN 764-1:2015+A1:2016 | Pressure equipment - Part 1: Vocabulary |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 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 |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| ISO 13408-3:2006 | Aseptic processing of health care products — Part 3: Lyophilization |
| 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 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 20857:2010 | Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO/TS 19930:2017 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| 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 |
| ISO 12749-4:2015 | Nuclear energy, nuclear technologies, and radiological protection — Vocabulary — Part 4: Dosimetry for radiation processing |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 18362:2016 | Manufacture of cell-based health care products — Control of microbial risks during processing |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| 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 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ISO 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO Guide 73:2009 | Risk management — Vocabulary |
| ISO 13408-5:2006 | Aseptic processing of health care products — Part 5: Sterilization in place |
| ISO 13408-2:2018 | Aseptic processing of health care products — Part 2: Sterilizing filtration |
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