Committee representation
Acknowledgment
Foreword
1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
3 Definitions, symbols, and abbreviations
4 Requirements
4.1 Requirements for EO sterilizers
4.1.1 Labeling
4.1.2 Sterilizer construction, components, and
accessories
4.1.3 Sterilizer safety
4.1.4 Process monitoring devices
4.1.5 Physical performance of sterilizers
4.1.6 Biological performance of sterilizers
4.1.7 Certification and recordkeeping
4.2 Requirements for EO sterilant sources
4.2.1 Registration
4.2.2 Labeling
4.2.3 Container safety
4.2.4 Product composition
4.2.5 Shipping
4.3 Requirements for EO emission control systems
4.3.1 System approvals
4.3.2 Labeling
4.3.3 Performance requirements
4.3.4 Safety requirements
4.3.5 Installation requirements
5 Tests
Annexes
A - Rationale for the development and provisions of this
standard
B - Calculating chamber relative humidity
C - Calculating chamber ethylene oxide concentration
D - Bibliography