AAMI TIR17665 2 2009 RA 2016
$140.32
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
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 65 |
AAMI/ISO TIR17665-2 provides guidance for validation and routine control of moist heat sterilization processes for medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 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 |
| 2 | Title page |
| 3 | Copyright information |
| 4 | AAMI Technical Information Report ANSI Technical Report |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of AAMI adoption of ISO/TS 17665-2:2009 |
| 12 | AAMI inclusion to ISO/TS 17665-2:2009 |
| 13 | Foreword |
| 14 | Introduction |
| 16 | 1 Scope 2 Normative references |
| 17 | 3 Terms and definitions 4 Quality management system elements 5 Sterilizing agent characterization 5.1 Sterilizing agent 5.2 Microbicidal effectiveness |
| 18 | 5.3 Material effects 5.4 Environmental considerations 6 Process and equipment characterization 6.1 Process 6.1.1 General |
| 19 | 6.1.2 Saturated steam processes |
| 21 | 6.1.3 Contained product processes 6.2 Equipment |
| 23 | 7 Product definition |
| 24 | 8 Process definition |
| 26 | 9 Validation 9.1 General |
| 27 | 9.2 Installation qualification (IQ) 9.2.1 Equipment 9.2.2 Installation 9.2.3 Function |
| 28 | 9.3 Operational qualification (OQ) |
| 29 | 9.4 Performance qualification (PQ) |
| 31 | 9.5 Review and approval of the validation |
| 32 | 10 Routine monitoring and control |
| 33 | 11 Product release from sterilization |
| 34 | 12 Maintaining process effectiveness 12.1 Demonstration of continued effectiveness 12.2 Recalibration 12.3 Maintenance of equipment 12.4 Requalification |
| 35 | 12.5 Assessment of change |
| 36 | Annex A Evaluation of a sterilization process primarily based on the measurement of physical parameters A.1 Introduction A.2 Hollow load test A.3 Standard test pack |
| 38 | A.4 Thermometric tests A.4.1 Small load thermometric test |
| 39 | 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 |
| 40 | 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 |
| 42 | A.12 Water A.13 Compressed air A.14 Test programs |
| 44 | Annex B Evaluation of a sterilization process primarily based on biological inactivation and an accompanying mechanical air removal procedure B.1 Introduction |
| 45 | B.2 Biological qualification of a sterilization process B.3 Biological challenge B.4 Mechanical air removal |
| 47 | Annex C Temperature and pressure of saturated steam for use in moist heat sterilization |
| 50 | Annex D Special considerations for health care settings D.1 Introduction D.2 Quality management system elements (additional guidance for ISO 17665-1:2006, 4.1) |
| 52 | D.3 Process and equipment characterization (additional guidance for ISO 17665-1:2006, Clause 6) D.3.1 Process (additional guidance for ISO 17665-1:2006, 6.1) |
| 53 | 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) 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) |
| 54 | 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) D.6.1 Operational qualification (additional guidance for ISO 17665-1:2006, 9.3.1) |
| 55 | D.6.2 Performance qualification (additional guidance on ISO 17665-1:2006, 9.4) 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 |
| 56 | 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) D.7.1 Additional guidance for ISO 17665-1:2006, 10.1 |
| 57 | 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) |
| 58 | D.9 Maintaining process effectiveness (additional guidance for ISO 17665-1:2006, Clause 12) 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) |
| 59 | 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 |
| 62 | Bibliography |
