AAMI 17665 1 2006 RA 2013
$131.66
ANSI/AAMI/ISO 17665-1:2006/(R)2013 – Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 57 |
Specifies requirements for the development, validation, and routine control of a moist heat sterilization process for medical devices used in any facility that manufacturers or reprocesses medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products – Moist heat – Part 1 Requirements for the development, validation, and routine control of a sterilization process for medical devices |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of AAMI adoption of ISO 17665-1:2006 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 1.1 Inclusions 1.2 Exclusions |
| 16 | 2 Normative references |
| 17 | 3 Terms and definitions |
| 25 | 4 Quality management system elements 4.1 Documentation 4.2 Management responsibility 4.3 Product realization |
| 26 | 5 Sterilizing agent characterization 5.1 Sterilizing agent 5.2 Microbicidal effectiveness 5.3 Materials effects 5.4 Environmental consideration 6 Process and equipment characterization 6.1 Process 6.1.1 General |
| 27 | 6.1.2 Saturated steam processes |
| 28 | 6.1.3 Contained product processes 6.2 Equipment |
| 30 | 7 Product definition |
| 31 | 8 Process definition |
| 32 | 9 Validation 9.1 General |
| 33 | 9.2 Installation qualification (IQ) 9.2.1 Equipment 9.2.2 Installation 9.2.3 Function 9.3 Operational qualification (OQ) 9.4 Performance qualification (PQ) |
| 35 | 9.5 Review and approval of validation |
| 36 | 10 Routine monitoring and control |
| 37 | 11 Product release from sterilization 12 Maintaining process effectiveness 12.1 Demonstration of continued effectiveness 12.2 Recalibration |
| 38 | 12.3 Maintenance of equipment 12.4 Requalification 12.5 Assessment of change |
| 39 | Annex A Guidance A.1 Scope A.1.1 Inclusions A.1.2 Exclusions A.2 Normative references |
| 40 | A.3 Terms and definitions A.4 Quality management system elements A.4.1 Documentation A.4.2 Management responsibility A.4.3 Product realization A.4.4 Measurement, analysis and improvement — Control of nonconforming product |
| 41 | A.5 Sterilizing agent characterization A.6 Process and equipment characterization A.7 Product definition A.8 Process definition |
| 42 | A.9 Validation A.10 Routine monitoring and control A.11 Product release from sterilization A.12 Maintaining process effectiveness |
| 44 | Annex B Process definition based on inactivation of the microbial population in its natural state (bioburden-based method) B.1 General B.2 Sampling B.3 Procedure B.4 Follow up |
| 45 | Annex C Process definition based on the inactivation of a reference microorganism and a knowledge of bioburden on product items to be sterilized (combined bioburden/biological indicator based method) C.1 General C.2 Procedure |
| 46 | Annex D Conservative process definition based on inactivation of reference microorganisms (overkill method) D.1 General D.2 Procedure D.3 Partial cycle approach |
| 47 | D.4 Full cycle approach |
| 48 | Annex E Operating cycles |
| 49 | E.3 Air pressurization operating cycles E.3.1 General E.3.2 Air steam mixtures E.3.3 Water spray |
| 50 | E.3.4 Water immersion |
| 55 | Bibliography |
