AAMI ISO TIR 17665-2 : 2009

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TIR17665-2:2009
AAMI inclusion to ISO TIR17665-2:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) - Evaluation of a sterilization
                        process primarily based on the
                        measurement of physical parameters
Annex B (informative) - Evaluation of a sterilization
                        process primarily based on
                        biological inactivation and an
                        accompanying mechanical air
                        removal procedure
Annex C (informative) - Temperature and pressure of
                        saturated steam for use in
                        moist heat sterilization
Annex D (informative) - Special considerations for health
                        care settings
Annex E (informative) - Index of normative clauses/subclauses
                        of ISO 17665-1 and cited references
                        or related guidance given in ISO
                        17665-1 and ISO/TS 17665-2
Bibliography

Specifies general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1.