AAMI 14937 2009 RA 2013
$120.68
ANSI/AAMI/ISO 14937:2009/(R) 2013 – Sterilization of health care products-General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 53 |
Specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. Applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. Intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of products to be sterilized and organizations responsible for sterilizing medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 14937:2009/(R)2013, Sterilization of health care products – General requirements for characterization of a sterilizing agent and 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 ANSI/AAMI/ISO 14937 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 1.1 Inclusions 1.2 Exclusions |
| 16 | 2 Normative references 3 Terms and definitions |
| 22 | 4 Quality management system elements 4.1 Documentation 4.2 Management responsibility 4.3 Product realization 4.4 Measurement, analysis and improvement — Control of non-conforming product 5 Sterilizing agent characterization 5.1 General |
| 23 | 5.2 Sterilizing agent 5.3 Microbicidal effectiveness 5.4 Effects on materials 5.5 Safety and the environment |
| 24 | 6 Process and equipment characterization 6.1 General 6.2 Process characterization 6.3 Equipment characterization |
| 25 | 7 Product definition 8 Process definition |
| 26 | 9 Validation 9.1 General |
| 27 | 9.2 Installation qualification 9.2.1 Equipment 9.2.2 Installation 9.3 Operational qualification |
| 28 | 9.4 Performance qualification |
| 29 | 9.5 Review and approval of validation 10 Routine monitoring and control 11 Product release from sterilization |
| 30 | 12 Maintaining process effectiveness 12.1 General 12.2 Recalibration 12.3 Maintenance of equipment 12.4 Requalification 12.5 Assessment of change |
| 31 | Annex A Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness A.1 General A.2 Identification of reference microorganism A.3 Selection of microorganisms |
| 33 | Annex B Approach 1 — Process definition based on inactivation of the microbial population in its natural state B.1 General B.2 Product selection B.3 Procedure B.4 Maintaining process effectiveness |
| 34 | Annex C Approach 2 — Process definition based on inactivation of reference microorganisms and knowledge of bioburden C.1 General C.2 Procedure |
| 35 | Annex D Approach 3 — Conservative process definition based on inactivation of reference microorganisms D.1 General D.2 Procedure |
| 37 | Annex E Guidance on application of this International Standard E.1 Scope E.2 Normative references E.3 Terms and definitions E.4 Quality management system elements E.4.1 Documentation E.4.2 Management responsibility |
| 41 | E.4.3 Product realization E.4.4 Measurement, analysis and improvement — Control of non-conforming product E.5 Sterilizing agent characterization E.5.1 General E.5.2 Sterilizing agent E.5.3 Microbicidal effectiveness |
| 44 | E.5.4 Effects on materials E.5.5 Safety and the environment E.6 Process and equipment characterization E.7 Product definition |
| 45 | E.8 Process definition |
| 47 | E.9 Validation E.9.1 General E.9.2 Installation qualification (IQ) E.9.3 Operational qualification (OQ) E.9.4 Performance qualification (PQ) |
| 48 | E.9.5 Review and approval of validation E.10 Routine monitoring and control |
| 49 | E.11 Product release from sterilization E.12 Maintaining process effectiveness E.12.1 General |
| 50 | E.12.2 Recalibration E.12.3 Maintenance of equipment E.12.4 Requalification E.12.5 Assessment of change |
| 52 | Bibliography |
