CSA ISO 11134 : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
Hardcopy , PDF
23-07-2013
English
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1 Scope
2 Normative references
3 Definitions
4 General
5 Equipment
6 Sterilization process development
7 Sterilization process validation
8 Routine moist heat sterilization
Annexes
A Guidance for validation and routine control of
industrial moist heat sterilization
B Sterilization cycles
C Bibliography
Gives requirements for using moist heat in sterilization process development, validation of the sterilization process and the routine control of sterilization.
| DevelopmentNote |
Supersedes CSA Z314.4 (06/2006)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| ISO 11134:1994 | 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 |
| IEC 61010-2-041:1995 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9003:1994 | Quality systems Model for quality assurance in final inspection and test |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
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