CSA Z314.2 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS
Hardcopy , PDF
01-03-2012
English, French
01-01-2009
Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 General requirements
4.1 General
4.2 Policy
4.3 Procedures
4.4 Manufacturer's instructions
4.5 Quality system
4.6 Documentation and records
4.7 Ethylene oxide safety
4.8 Alerts
5 Evaluation and purchase of reusable medical devices and
sterilization supplies
5.1 General
5.2 Manufacturer's instructions
5.3 Packaging materials
5.4 Sterilization indicators and PCDs
6 Personnel
6.1 General
6.2 Qualifications
6.3 Orientation, training, and continuing education
6.4 Competency assessment
6.5 Immunization
6.6 Routine infection prevention and control practices
6.7 Attire
6.8 Ethylene oxide leaks
7 Work areas and equipment
7.1 Area design
7.2 Sterile storage area
7.3 Traffic control
7.4 Environmental controls
7.5 Area cleaning
7.6 Sterilization equipment
8 Preparation
8.1 General
8.2 Decontamination
8.3 Lubrication
8.4 Preparations to ensure sterilant contact with all
surfaces
9 Packaging
9.1 General
9.2 Wrapping materials
9.3 Sterilization pouches
9.4 Rigid sterilization containers
9.5 Packaging methods
10 Sterilizer loading and operation loading
10.1 Loading
10.2 Sterilizer operation
10.3 Aeration
10.4 Opening of sterilizer door at cycle completion
10.5 Sterilizer unloading
10.6 Dust covers
10.7 Safe handling, storage, and disposal of ethylene oxide
cylinders and cartridges
11 Storage
11.1 General
11.2 Storage area
11.3 Inventory management
11.4 Distribution
12 Sterility assurance
12.1 General
12.2 Tools and indicators for monitoring
12.3 Installation qualification
12.4 Operational qualification and requalification
12.5 Performance qualification
12.6 Routine monitoring
12.7 Documenting sterility assurance procedures and
test results
12.8 Interpretation and response to failed chemical
indicators
12.9 Interpretation and response to failed biological
indicators
12.10 Recalls
12.11 In-house prepared PCDs
13 Maintenance and sterilizer quality assurance
Annexes
A (informative) - Sample job descriptions
B (informative) - Guidance for the design of medical device
reprocessing areas
C (Informative) - High relative humidity in sterile storage
areas
D (informative) - Risk management and sterility assurance
E (informative) - Additional guidance on sterilization
indicators and PCDs
F (informative) - Relevant Standards
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