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