I.S. EN ISO 11135-1:2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2007
02-08-2014
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
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control
of nonconforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material 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
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 (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) General guidance
Annex ZA (informative) Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC Medical devices
Bibliography
Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
| DevelopmentNote |
Supersedes I.S. EN 550. (09/2007)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11135-1 : 2007 | Identical |
| NEN EN ISO 11135-1 : 2007 | Identical |
| NS EN ISO 11135-1 : 1ED 2007 | Identical |
| DIN EN ISO 11135-1:2007-08 | Identical |
| ISO 11135-1:2007 | Identical |
| BS EN ISO 11135-1:2007 | Identical |
| EN ISO 11135-1:2007 | Identical |
| NBN EN ISO 11135-1 : 2007 | Identical |
| DIN EN ISO 11135-1:2007-08 | Equivalent |
| UNE-EN ISO 11135-1:2007 | Identical |
A newer version of this standard is available.
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