UNI CEN ISO/TS 11135-2 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
10-09-2014
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control
of non-conforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Materials effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process characterization
6.2 Equipment characterization
7 Product definition
7.1 General
7.2 Product safety and performance
7.3 Microbiological quality
7.4 Documentation
8 Process definition
9 Validation
9.1 Installation qualification
9.2 Operational qualification
9.3 Performance qualification
9.4 Varying load configurations
9.5 Review and approval of validation
10 Routine monitoring and control
10.1 General
10.2 Parametric release
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
Annex A (informative) - Guidance on ISO 11135-1:2007
Annex A Determination of process
lethality - Biological indicator/bioburden
approach
Annex B (informative) - Guidance on ISO 11135-1:2007
Annex B Conservative determination of lethal
rate of the sterilization process - Overkill
approach
Bibliography
Describes guidance for the requirements in ISO 11135-1:2007.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/TS 11135-2:2008 | Identical |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| AS/NZS 4187:2014 | Reprocessing of reusable medical devices in health service organisations |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| 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 |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| 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 |
| AAMI TIR28 : 2016 | PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| AAMI TIR15 : 2016 | PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| 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 15883-4:2008 | Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| 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 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
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