I.S. EN ISO 11135:2014&A1:2019/LC:2019
Current
The latest, up-to-date edition.
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Hardcopy , PDF
English
11-12-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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) Temperature sensors, RH sensors and biological indicator numbers
Annex D (informative) Guidance on the application of the normative requirements
Annex E (normative) Single Lot Release
Bibliography
This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
128
|
| ProductNote |
THIS STANDARD IS ALSO REFERES TO ISO 11138-2 ISO 13485, AAMI ST41,AS/NZS 4187 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11135:2014/Amd 1:2018 | Identical |
| ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| EN 556-1:2001 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| 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 |
| ISO 9000:2005 | Quality management systems — Fundamentals and vocabulary |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 22442-1:2007 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 9001:2000 | Quality management systems — Requirements |
| 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 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 10993-1:1992 | Biological evaluation of medical devices — Part 1: Guidance on selection of tests |
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