AAMI 11140 1 2014
$93.55
ANSI/AAMI/ISO 11140-1:2014 – Sterilization of health care products – Chemical indicators – Part 1: General requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 41 |
Specifies performance requirements for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11140-1:2014, Sterilization of healthcare products—Chemical indicators—Part 1: General requirements |
| 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 |
| 7 | Committee representation |
| 9 | Background of AAMI adoption of ISO 11140-1:2014 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 16 | 4 Categorization 4.1 General Table 1 — Categories according to intended use |
| 17 | 4.2 Type 1: process indicators 4.3 Type 2: indicators for use in specific tests 4.4 Type 3: single critical process variable indicators 4.5 Type 4: multicritical process variable indicators 4.6 Type 5: integrating indicators 4.7 Type 6: emulating indicators 5 General requirements |
| 20 | Figure 1—Symbol for designation for use with a specific test load only 6 Performance requirements 6.1 General 6.2 Type 1 indicators |
| 21 | 6.3 Type 2 indicators 6.4 Types 3, 4, 5 and 6 indicators 7 Test methods 7.1 General 7.2 Off-set (transference) 7.3 Procedure — Steam indicators |
| 22 | 7.4 Procedure — Dry heat indicators 7.5 Procedure — EO indicators |
| 23 | 7.6 Procedure — Low temperature steam and formaldehyde indicators 7.7 Procedure — Vaporized hydrogen peroxide indicators |
| 24 | 8 Additional requirements for process (Type 1) indicators 8.1 Process indicators printed or applied on to packaging material 8.2 Process indicators for steam sterilization processes Table 2 — Test and performance requirements for Type 1 process indicators for 8.3 Process indicators for dry heat sterilization processes |
| 25 | 8.4 Process indicators for ethylene oxide sterilization processes Table 4 — Test and performance requirements for Type 1 process indicators for 8.5 Process indicators for radiation sterilization processes |
| 26 | Table 5 — Test and performance requirements for Type 1 process indicators for IRRAD 8.6 Process indicators for low temperature steam and formaldehyde sterilization processes Table 6 — Test conditions and performance requirements for Type 1 process indicators for FORM |
| 27 | 8.7 Process indicators for vaporized hydrogen peroxide sterilization processes Table 7 — Test conditions and performance requirements for Type 1 process indicators for 9 Additional requirements for single critical process variable (Type 3) indicators 10 Additional requirements for multicritical process variable (Type 4) indicators |
| 28 | Table 8 — Test and performance requirements for Type 3 and Type 4 indicators 11 Additional requirements for steam integrating (Type 5) indicators |
| 29 | 12 Additional requirements for ethylene oxide integrating (Type 5) indicators Table 9 — Test and performance requirements for Type 5 indicators 13 Additional requirements for emulating (Type 6) indicators |
| 30 | Table 10 — Test and performance requirements for Type 6 indicators |
| 31 | Annex A: Method for demonstrating shelf-life of the product |
| 32 | Annex B: Examples of testing indicators B.1 Example of testing single critical process variable (Type 3) indicator for dry heat processes B.2 Example of testing multicritical process variable indicator for steam processes B.3 Example of testing emulating (Type 6) indicators for steam processes |
| 33 | Annex C: Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators specified in ISO 11138 (all parts) and microbial inactivation C.1 Steam C.1.1 General C.1.2 Background information |
| 34 | Figure C.1—Type 5 plot |
| 35 | C.2 The link between the integrating indicator SV and BI inactivation C.2.1 Accept or pass (end point attained) criteria C.2.2 Reject or fail (end point not attained) criteria |
| 36 | C.3 The response of the integrating indicator at different temperatures and the relationship to the biological indicator’s z-value |
| 37 | C.4 Ethylene oxide |
| 39 | Annex D: Rationale for the liquid-phase test method for low temperature steam and formaldehyde indicators D.1 General D.2 The low temperature steam and formaldehyde process D.3 Chemical indicators |
| 40 | Annex E: Relationship of indicator and indicator system components Figure E.1 — Relationship of indicator and indicator system components |
| 41 | Bibliography |
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