AAMI ST63 : 2002

Glossary of equivalent standards
Committee representation
Acknowledgment
Foreword
1 Scope
2 Normative references
3 Definitions
4 Quality systems
   4.1 Assignment of personnel responsibilities
   4.2 Documentation and records
   4.3 Design control
   4.4 Calibration
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
   5.4 Safety and environment
6 Process and equipment characteristics
   6.1 General
   6.2 Process monitoring
        6.2.1 Process parameters
        6.2.2 Tolerance of the parameters
        6.2.3 Process monitoring locations
   6.3 Documentation of equipment
        6.3.1 Identification
        6.3.2 Safety
        6.3.3 Manuals and instructions
        6.3.4 Additional information
   6.4 Sterilization system performance, utilities,
        components, accessories, and controls
        6.4.1 Performance
        6.4.2 Utilities
        6.4.3 Components
        6.4.4 Accessories
        6.4.5 Control and recording systems
        6.4.6 Control programs
   6.5 Performance of instruments
        6.5.1 Instrument accuracy
        6.5.2 Calibration standards
        6.5.3 Calibration program
   6.6 Maintenance
7 Product definition
   7.1 Introduction
   7.2 Product considerations
   7.3 Packaging considerations
   7.4 Bioburden
8 Process definition
   8.1 Introduction
   8.2 Selection of the sterilization process
   8.3 Sterilization process development
        8.3.1 Process variables
        8.3.2 Sterility assurance level
        8.3.3 Cycle development
   8.4 Process challenge devices
   8.5 Sterility testing
   8.6 Biocompatibility
   8.7 Depyrogenation
9 Sterilization process validation
   9.1 General
   9.2 Installation qualification
   9.3 Operational qualification
   9.4 Performance qualification
        9.4.1 Performance qualification-Physical
        9.4.2 Performance qualification-Microbiological
   9.5 Parametric release
   9.6 Other sterilization systems
   9.7 Validation report
10 Routine monitoring and control
   10.1 Process control systems
   10.2 Process recording systems
   10.3 Microbiological testing
11 Product release
12 Maintaining process effectiveness
   12.1 Maintenance
   12.2 Calibration
   12.3 Requalification
   12.4 Change control
Annexes
A - Guidance on application of this standard
B - Bibliography

Describes requirements for the development, validation, and routine control of an industrial dry heat sterilization process for medical devices.