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ANSI/AAMI/ISO TIR17665-2:2009/(R)2016 - Technical Information Report Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1, 2009
- ANSI/AAMI/ISO TIR17665-2:2009/(R)2016, Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
- Title page
- Copyright information
- AAMI Technical Information Report
- ANSI Technical Report
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of AAMI adoption of ISO/TS 17665-2:2009
- AAMI inclusion to ISO/TS 17665-2:2009
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management system elements
- 5 Sterilizing agent characterization [Go to Page]
- 5.1 Sterilizing agent
- 5.2 Microbicidal effectiveness
- 5.3 Material effects
- 5.4 Environmental considerations
- 6 Process and equipment characterization [Go to Page]
- 6.1 Process [Go to Page]
- 6.1.1 General
- 6.1.2 Saturated steam processes
- 6.1.3 Contained product processes
- 6.2 Equipment
- 7 Product definition
- 8 Process definition
- 9 Validation [Go to Page]
- 9.1 General
- 9.2 Installation qualification (IQ) [Go to Page]
- 9.2.1 Equipment
- 9.2.2 Installation
- 9.2.3 Function
- 9.3 Operational qualification (OQ)
- 9.4 Performance qualification (PQ)
- 9.5 Review and approval of the validation
- 10 Routine monitoring and control
- 11 Product release from sterilization
- 12 Maintaining process effectiveness [Go to Page]
- 12.1 Demonstration of continued effectiveness
- 12.2 Recalibration
- 12.3 Maintenance of equipment
- 12.4 Requalification
- 12.5 Assessment of change
- Annex A Evaluation of a sterilization process primarily based on the measurement of physical parameters [Go to Page]
- A.1 Introduction
- A.2 Hollow load test
- A.3 Standard test pack
- A.4 Thermometric tests [Go to Page]
- A.4.1 Small load thermometric test
- A.4.2 Full load thermometric test
- A.5 Bowie and Dick test
- A.6 Air leakage flow rate test
- A.7 Air detector tests (if fitted), small load, full load and function
- A.8 Load dryness — Small and full load with textiles, full load with metal
- A.9 Sound power test
- A.10 Dynamic pressure test
- A.11 Steam quality tests
- A.12 Water
- A.13 Compressed air
- A.14 Test programs
- Annex B Evaluation of a sterilization process primarily based on biological inactivation and an accompanying mechanical air removal procedure [Go to Page]
- B.1 Introduction
- B.2 Biological qualification of a sterilization process
- B.3 Biological challenge
- B.4 Mechanical air removal
- Annex C Temperature and pressure of saturated steam for use in moist heat sterilization
- Annex D Special considerations for health care settings [Go to Page]
- D.1 Introduction
- D.2 Quality management system elements (additional guidance for ISO 17665-1:2006, 4.1)
- D.3 Process and equipment characterization (additional guidance for ISO 17665-1:2006, Clause 6) [Go to Page]
- D.3.1 Process (additional guidance for ISO 17665-1:2006, 6.1)
- D.3.2 Equipment (additional guidance for ISO 17665-1:2006, 6.2.)
- D.4 Product definition in health care facilities (additional guidance for ISO 17665-1:2006, Clause 7) [Go to Page]
- D.4.1 Additional guidance on ISO 17665-1:2006, 7.1
- D.4.2 Additional guidance on ISO 17665-1:2006, 7.3
- D.4.3 Additional guidance on ISO 17665-1:2006, 7.10
- D.5 Process definition (additional guidance for ISO 17665-1:2006, Clause 8) [Go to Page]
- D.5.2 Additional guidance on ISO 17665-1:2006, 8.3
- D.5.3 Additional guidance on ISO 17665-1:2006, 8.4
- D.5.4 Additional guidance on ISO 17665-1:2006, 8.12
- D.6 Validation (additional guidance for ISO 17665-1:2006, Clause 9) [Go to Page]
- D.6.1 Operational qualification (additional guidance for ISO 17665-1:2006, 9.3.1)
- D.6.2 Performance qualification (additional guidance on ISO 17665-1:2006, 9.4) [Go to Page]
- D.6.2.1 Additional guidance for ISO 17665-1:2006, 9.4.1
- D.6.2.2 Additional guidance for ISO 17665-1:2006, 9.4.2
- D.6.2.3 Additional guidance for ISO 17665-1:2006, 9.4.4
- D.6.3 Review and approval of the validation (additional guidance for ISO 17665-1:2006, 9.5.2)
- D.7 Routine monitoring and control (additional guidance for ISO 17665-1:2006, Clause 10) [Go to Page]
- D.7.1 Additional guidance for ISO 17665-1:2006, 10.1
- D.7.2 Additional guidance for ISO 17665-1:2006, 10.3
- D.8 Product release from sterilization (additional guidance for ISO 17665-1:2006, 11.1)
- D.9 Maintaining process effectiveness (additional guidance for ISO 17665-1:2006, Clause 12) [Go to Page]
- D.9.1 Recalibration (additional guidance for ISO 17665-1:2006, 12.2)
- D.9.2 Maintenance of equipment (additional guidance for ISO 17665-1:2006, 12.3.1)
- D.9.3 Requalification (additional guidance for ISO 17665-1:2006, 12.4.1)
- Annex E 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
- Blank Page [Go to Page]