I.S. EN ISO 11135:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
Hardcopy , PDF
English
01-01-2014
17-12-2019
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.
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of Directive 93/42/EEC
Defines 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.
| DevelopmentNote |
Supersedes SR CEN ISO/TS 11135-2 and I.S. EN ISO 11135-1. (08/2014)
|
| DocumentType |
Standard
|
| Pages |
100
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11135:2014 | Identical |
| ISO 11135:2014 | Identical |
| DIN EN ISO 11135:2014-10 | Equivalent |
| BS EN ISO 11135:2014 | Equivalent |
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