CSA ISO 11137 : 1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
Hardcopy , PDF
01-10-2008
French
01-01-2003
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1 Scope
2 Normative references
3 Definitions
4 Documentation
5 Personnel
6 Sterilization process validation
6.1 General
6.2 Product qualification
6.3 Installation qualification
6.4 Process qualification
6.5 Certification
6.6 Maintenance of validation
7 Routine process control
7.1 process specification
7.2 Product handling
7.3 Routine and preventive maintenance
7.4 Product irradiation
7.5 Process documentation
7.6 Sterilization acceptance
8 Management and control
Annexes
A Device and packaging materials qualification
B Dose setting methods for radiation sterilization
C Dosimeters, dosimetry and associated equipment
D Bibliography
Gives requirements for process control, validation and routine monitoring in the radiation sterilization of health care products.
| DocumentType |
Standard
|
| Pages |
76
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137:1995 | Identical |
| 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 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 9001:2015 | Quality management systems — Requirements |
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