AAMI ST63 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
08-12-2010
English
01-01-2002
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
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