I.S. EN ISO 11135:2014&A1:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Hardcopy , PDF
14-03-2020
English
26-11-2019
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.
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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 |
TC 198
|
| DocumentType |
Standard
|
| Pages |
0
|
| ProductNote |
THIS STANDARD ALSO REFERS TO EN 556-1 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 |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11135:2014/Amd 1:2018 | Identical |
| ISO 11135:2014 | Identical |
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