AAMI 15882 2008 RA 2013
$115.49
ANSI/AAMI/ISO 15882:2008/(R)2013 – Sterilization of health care products – Chemical indicators-Guidance for selection, use and interpretation of results.
| Published By | Publication Date | Number of Pages |
| AAMI | 2008 | 48 |
This document provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. AAMI/ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 15882:2008/(R)2013, Sterilization of health care products — Chemical indicators— Guidance for selection, use and interpretation of results |
| 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 |
| 12 | Background of AAMI adoption of ISO 15882:2008 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Terms and definitions |
| 17 | 3 General considerations |
| 20 | 4 Classes of chemical indicator 4.1 General 4.2 Class 1: Process indicators |
| 21 | 4.3 Class 2: Indicators for use in specific tests 4.4 Class 3: Single variable indicators |
| 23 | 4.5 Class 4: Multi-variable indicators 4.6 Class 5: Integrating indicators |
| 24 | 4.7 Class 6: Emulating indicators |
| 25 | 5 Selection of chemical indicators |
| 26 | 6 Use of chemical indicators 6.1 Class 1 process indicators 6.2 Class 2 indicators 6.3 Class 3, 4, 5 and 6 indicators 6.4 Indicators for use with process challenge devices |
| 27 | 7 Interpretation of results from chemical indicators 7.1 General |
| 28 | 7.2 Chemical indicator responses 7.3 Chemical indicators showing “fail” response 8 Chemical indicators in sterility assurance procedures 8.1 General |
| 29 | 8.2 Record keeping 9 Personnel training 10 Storage and handling |
| 30 | 11 Labeling 11.1 General 11.2 Indicator marking 11.3 Process marking 11.4 Package marking |
| 32 | Annex A Background on the Bowie and Dick test |
| 35 | Annex B Explanation of the terms “parameter” and “variable” |
| 36 | Annex C Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in the ISO 11138 series and microbial inactivation (derived from ISO 11140-1) C.1 Steam C.1.1 Introduction C.1.2 Background information C.2 The link between the integrator stated value (SV) and biological indicator (BI) inactivation |
| 39 | C.3 Comparison with the requirements for integrating indicators in ISO 11140-1 |
| 42 | C.4 Ethylene oxide |
| 44 | Annex D Specifications for porosity D.1 General D.2 Comparison of five paper samples D.2.1 Test materials D.2.2 Conditions D.2.3 Test methods D.2.3.1 Air permeance in accordance with ISO 5636-3 D.2.3.2 Air permeance in accordance with ISO 5636-5[2] |
| 45 | D.2.4 Test results |
| 46 | Annex E Figure showing relationship of indicator components |
| 47 | Bibliography |
