DD CEN ISO/TS 11135-2:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Guidance on the application of ISO 11135-1
Hardcopy , PDF
English
30-09-2011
15-01-2020
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/bombardon approach
Annex B (informative) - Guidance on ISO 11135-1:2007 Annex B
Conservative determination of lethal rate
of the sterilization process - Overkill
approach
Bibliography
Gives guidance for the requirements in ISO 11135-1:2007.
| Committee |
CH/198
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
British Standards Institution
|
| RevisionOf | |
| Status |
Superseded
|
| SupersededBy |
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.
The exclusions in ISO 11135-1 apply also to this Technical Specification.
For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
| Standards | Relationship |
| ISO/TS 11135-2:2008 | Identical |
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