CSA ISO 11135 : 1998:R2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
Hardcopy , PDF
01-03-2009
French
01-01-2003
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1 Scope
2 Normative references
3 Definitions
4 General
4.1 Personnel
4.2 Process development and product compatibility
4.3 Sterilization process
4.4 Equipment
4.5 Calibration
4.6 Maintenance
5 Validation
5.1 General
5.2 Commissioning
5.3 Performance qualification - physical
5.4 Performance qualification - microbiological
5.5 Certification of validation
5.6 Revalidation
6 Process control and monitoring
7 Product release
7.1 Conventional product release
7.2 Parametric release
Annexes
A General aspects of sterilization
B Validation
C Process control and monitoring [6]
D Product release [7]
Specifies guidance and requirements for routine control and validation of ethylene oxide sterilization processes for medical devices.
| DevelopmentNote |
Supersedes CSA Z314.5 (06/2006)
|
| DocumentType |
Standard
|
| Pages |
41
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| ISO 11135:2014 | Identical |
| CSA Z8638 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| CSA Z8637 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| CSA Z10651-5 : 2008 : R2018 | Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
| CSA Z10651-5 : 2008 : R2013 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA Z10651-5 : 2008 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
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