AAMI 11137 1 2006 RA 2015 A12013 A2 2019
$140.32
ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 – Sterilization of health care products-Radiation-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 54 |
Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or X-ray generator.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 (Consolidated Text), Sterilization of health care products —Radiation — Part 2: Requirements for 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 |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Background of AAMI adoption of ISO 11137-1:2006 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope |
| 16 | 2 Normative references 3 Terms and definitions |
| 23 | 4 Quality management system elements 4.1 Documentation 4.2 Management responsibility 4.3 Product realization 4.4 Measurement, analysis, and improvement — Control of nonconforming product |
| 24 | 5 Sterilizing agent characterization 5.1 Sterilizing agent 5.2 Microbicidal effectiveness 5.3 Material effects 5.4 Environmental considerations 6 Process and equipment characterization 6.1 Process 6.2 Equipment |
| 26 | 7 Product definition |
| 27 | 8 Process definition 8.1 Establishing the maximum acceptable dose 8.2 Establishing the sterilization dose 8.3 Specifying the maximum acceptable dose and the sterilization dose |
| 28 | 8.4 Transference of maximum acceptable, verification, or sterilization dose between radiation sources 8.4.1 Transference of maximum acceptable dose 8.4.2 Transference of verification dose or sterilization dose 9 Validation 9.1 Installation qualification |
| 29 | 9.2 Operational qualification |
| 30 | 9.3 Performance qualification 9.4 Review and approval of validation |
| 32 | 10 Routine monitoring and control 11 Product release from sterilization |
| 33 | 12 Maintaining process effectiveness 12.1 Demonstration of continued effectiveness 12.1.1 General 12.1.2 Frequency of determinations of bioburden |
| 34 | 12.1.3 Frequency of sterilization dose audits |
| 35 | 12.2 Recalibration 12.3 Maintenance of equipment |
| 36 | 12.4 Requalification of equipment 12.5 Assessment of change |
| 37 | Annex A (informative) Guidance A.1 Scope A.2 Normative references |
| 38 | A.3 Terms and definitions A.4 Quality management system elements A.4.1 Documentation A.4.2 Management responsibility |
| 39 | A.4.3 Product realization A.4.4 Measurement, analysis and improvement — Control of nonconforming product |
| 40 | A.5 Sterilizing agent characterization A.5.1 Sterilizing agent A.5.2 Microbicidal effectiveness A.5.3 Material effects A.5.4 Environmental considerations A.6 Process and equipment characterization |
| 41 | A.7 Product definition |
| 42 | A.8 Process definition A.8.1 Establishing the maximum acceptable dose A.8.2 Establishing the sterilization dose |
| 43 | A.8.3 Specifying the maximum acceptable dose and the sterilization dose A.8.4 Transference of maximum acceptable, verification or sterilization dose between radiation sources A.8.4.1 Transference of maximum acceptable dose A.8.4.2 Transference of verification or sterilization dose |
| 44 | A.9 Validation A.9.1 Installation qualification A.9.2 Operational qualification A.9.3 Performance qualification A.9.4 Review and approval of validation |
| 45 | A.10 Routine monitoring and control |
| 46 | A.11 Product release from sterilization A.12 Maintaining process effectiveness A.12.1 Demonstration of continued effectiveness A.12.1.1 General |
| 47 | A.12.1.2 Frequency of determinations of bioburden A.12.1.3 Frequency of sterilization dose audits |
| 48 | A.12.2 Recalibration A.12.3 Maintenance of equipment A.12.4 Requalification of equipment A.12.5 Assessment of change |
| 53 | Bibliography |
