AAMI 20857 2010 RA 2015
$140.32
ANSI/AAMI/ISO 20857:2010/(R)2015 – Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 76 |
Specifies requirements for the development, validation and routine control of an industrial dry heat sterilization process for medical devices. Dry heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwaves as the heating medium.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 20857:2010/(R)2015, Sterilization of health care products — Dry heat —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 | Table of contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of ANSI/AAMI adoption of ISO 20857:2010 |
| 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 4.4 Measurement, analysis and improvement — Control of nonconforming product |
| 26 | 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 characterization 6.2 Equipment characterization 6.2.1 Equipment specification 6.2.2 Identification |
| 27 | 6.2.3 Safety 6.2.4 Manuals and instructions 6.2.5 Utilities 6.2.6 Components 6.2.7 Accessories |
| 28 | 6.2.8 Control and recording systems 6.2.9 Control programs |
| 29 | 7 Product definition 7.1 General 7.2 Product safety and performance 7.3 Packaging considerations 7.4 Microbiological quality |
| 30 | 7.5 Product family 7.6 Biological safety 8 Process definition |
| 31 | 9 Validation 9.1 General 9.2 Installation qualification |
| 32 | 9.3 Operational qualification 9.4 Performance qualification 9.4.1 General |
| 33 | 9.4.2 Performance qualification — Physical 9.4.3 Performance qualification — Microbiological |
| 34 | 9.4.4 Performance qualification — Depyrogenation 9.5 Additional sterilization systems 9.6 Review and approval of validation |
| 35 | 10 Routine monitoring and control 10.1 Routine control 10.2 Routine monitoring |
| 36 | 10.3 Process monitoring locations |
| 37 | 11 Product release from sterilization/depyrogenation 12 Maintaining process effectiveness 12.1 General 12.2 Recalibration 12.3 Maintenance of equipment 12.4 Requalification |
| 38 | 12.5 Assessment of change |
| 39 | Annex A, Guidance on the application of this International Standard A.1 Scope A.1.1 Inclusions A.1.2 Exclusions A.2 Normative references A.3 Terms and definitions |
| 40 | A.4 Quality management systems 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.5.1 Sterilizing agent A.5.2 Microbicidal effectiveness A.5.3 Material effects A.6 Process and equipment characterization A.6.1 Process characterization |
| 43 | A.6.2 Equipment characterization A.6.2.1 Equipment specification |
| 44 | A.6.2.2 Identification A.6.2.3 Safety A.6.2.4 Manuals and instructions |
| 45 | A.6.2.5 Utilities A.6.2.6 Components |
| 46 | A.6.2.7 Accessories A.6.2.8 Control and recording systems |
| 47 | A.6.2.9 Control programs A.7 Product definition A.7.1 General |
| 48 | A.7.2 Product safety and performance A.7.3 Packaging considerations A.7.4 Microbiological quality |
| 49 | A.7.5 Product family A.7.6 Biological safety A.8 Process definition |
| 51 | A.9 Validation A.9.1 General |
| 52 | A.9.2 Installation qualification |
| 53 | A.9.3 Operational qualification |
| 54 | A.9.4 Performance qualification A.9.4.1 General A.9.4.2 Performance qualification — Physical |
| 55 | A.9.4.3 Performance qualification — Microbiological A.9.4.4 Performance qualification — Depyrogenation |
| 56 | A.9.5 Additional sterilization systems |
| 58 | A.9.6 Review and approval of validation |
| 59 | A.10 Routine monitoring and control A.10.1 Routine control |
| 60 | A.10.2 Routine monitoring A.10.3 Process monitoring locations A.11 Product release from sterilization/depyrogenation |
| 61 | A.12 Maintaining process effectiveness A.12.1 General A.12.2 Recalibration A.12.3 Maintenance of equipment |
| 62 | A.12.4 Requalification |
| 63 | A.12.5 Assessment of change |
| 64 |
Annex B, Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) B.1 General B.2 Product selection B.3 Procedure |
| 65 | B.4 Maintaining process effectiveness |
| 66 | Annex C, Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach) C.1 General C.2 Procedure |
| 67 | C.3 Process lethality determination C.3.1 Direct enumeration C.3.2 Fraction-negative method using Holcomb-Spearman-Karber approach (HSKP) |
| 68 | C.3 Fraction-negative method using Stumbo Murphy Cochran Procedure (SMCP) |
| 69 | Annex D, Conservative process definition based on inactivation of reference microorganisms (overkill method) D.1 General |
| 70 | D.2 Product selection D.3 Procedure D.4 Partial cycle approach |
| 71 | D.5 Full cycle approach |
| 72 | Annex E, Process development E.1 Process development — Biological methods |
| 73 | E.2 Process development — Physical methods |
| 75 | Bibliography |
