AAMI 14160 2011 RA 2016
$140.32
ANSI/AAMI/ISO 14160:2011/(R)2016 – Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 50 |
Specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 14160:2011/(R)2016, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, 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 ANSI/AAMI adoption of ISO 14160:2011 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope |
| 16 | 2 Normative references 3 Terms and definitions |
| 20 | 4 Quality management system elements 4.1 Documentation 4.2 Management responsibility 4.3 Product realization |
| 21 | 4.4 Measurement, analysis and improvement — Control of non-conforming products 5 Sterilizing agent characterization 5.1 General 5.2 Sterilizing agent 5.3 Microbicidal effectiveness |
| 22 | 5.4 Effects on materials 5.5 Safety and the environment 6 Process and equipment characterization 6.1 General 6.2 Process characterization |
| 23 | 6.3 Equipment characterization 7 Product definition |
| 24 | 8 Process definition 8.1 Purpose 8.2 Determination of the inactivation kinetics |
| 25 | 8.3 Method for neutralization 8.4 Safety quality and performance 9 Validation 9.1 General |
| 26 | 9.2 Installation qualification 9.2.1 Equipment 9.2.2 Installation 9.3 Operational qualification |
| 27 | 9.4 Performance qualification 9.4.1 General 9.4.2 Microbiological performance qualification 9.4.2.1 Combined reference organism/bioburden approach |
| 28 | 9.4.2.2 Overkill approach 9.4.3 Physical performance qualification |
| 29 | 9.4.4 Aseptic processing qualification 9.5 Review and approval of validation |
| 30 | 10 Routine monitoring and control |
| 31 | 11 Product release from sterilization |
| 32 | 12 Maintaining process effectiveness 12.1 General 12.2 Maintenance of equipment 12.3 Requalification 12.4 Assessment of change |
| 33 | Annex A Guidance for the application of this International Standard A.1 General considerations A.2 Normative references A.3 Quality management system elements A.3.1 Documentation A.3.2 Management responsibility |
| 34 | A.4 Sterilizing agent characterization A.5 Product definition |
| 37 | A.6 Process definition |
| 42 | A.7 Validation A.8 Routine monitoring and control |
| 43 | A.9 Product release from sterilization |
| 44 | A.10 Maintaining process effectiveness |
| 45 | Annex B Determination of lethal rate of the sterilization process B.1 Combined reference organism/bioburden approach B.1.1 General B.1.2 Procedure |
| 46 | B.1.3 Process lethality determination B.1.3.1 Direct enumeration (survivor curve) B.1.3.2 Fraction negative method using the Holcomb-Spearman-Karber procedure (HSKP) |
| 47 | B.1.3.3 Fraction negative method using the Stumbo-Murphy-Cochran procedure (SMCP) B.2 Overkill approach B.2.1 General |
| 48 | B.2.2 Procedure |
| 49 | Annex C Flowchart for microbicidal effectiveness (see 5.3), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2) |
| 50 | Bibliography |
