AAMI TIR31 2008
$115.49
AAMI TIR31:2008 – Process challenge devices/test packs for use in health care facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2008 | 46 |
This technical information report provides information that will assist health care facilities in the selection and use of process challenge devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR31:2008, Process challenge devices/test packs for use in health care facilities |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Definitions and abbreviations |
| 15 | 4 Historical development of PCDs 5 Selection and use of process challenge devices/test packs |
| 17 | 6 Process challenge devices 6.1 PCDs for steam sterilization 6.1.1 Introduction |
| 20 | 6.1.2 Description 6.1.3 Reference BI PCDs—AAMI challenge and routine BI PCDs 6.1.4 Types of BI PCDs 6.1.4.1 Commercial BI PCDs |
| 21 | 6.1.4.2 Health care facility–prepared PCDs 6.1.5 Recommended practices—Application and frequency of use 6.1.5.1 AAMI challenge BI PCD 6.1.5.2 AAMI routine BI PCD 6.2 BI PCDs for ethylene oxide sterilization 6.2.1 Introduction 6.2.2 Description |
| 22 | 6.2.3 Reference BI PCDs 6.2.3.1 AAMI challenge BI PCD 6.2.3.2 AAMI routine BI PCD 6.2.4 Types of BI PCDs 6.2.4.1 Commercial BI PCDs 6.2.4.2 Health care facility–prepared PCDs 6.2.5 Recommended practices—Application and frequency of use 6.2.5.1 AAMI challenge BI PCD 6.2.5.2 AAMI routine BI PCD |
| 23 | 6.3 BI PCDs for table-top dry heat sterilization 6.3.1 Introduction 6.3.2 Description 6.3.3 Reference BI PCDs 6.3.4 Types of BI PCDs 6.3.4.1 Commercial BI PCDs 6.3.4.2 Health care facility–prepared BI PCDs 6.3.5 Recommended practices—Application and frequency of use 6.4 BI PCDs for hydrogen peroxide sterilization 6.4.1 Introduction |
| 24 | 6.4.2 Description 6.4.3 Reference BI PCDs 6.4.4 Types of BI PCDs 6.4.4.1 Commercial BI PCDs 6.4.4.2 Health care facility–prepared PCDs 6.4.5 Recommended practices—Application and frequency of use 6.5 BI PCDs for ozone sterilization process 6.5.1 Introduction 6.5.2 Description |
| 25 | 6.5.3 Reference BI PCDs 6.5.4 Types of BI PCDs 6.5.4.1 Commercial BI PCDs 6.5.4.2 Health care facility–prepared BI PCDs 6.5.5 Recommended practices—Application and frequency of use |
| 26 | Annex A Regulatory perspective |
| 27 | Annex B The Bowie-Dick test pack B.1 Introduction B.2 Description B.3 Reference PCDs |
| 28 | B.4 Types of PCDs for the Bowie-Dick test B.4.1 Commercial Bowie-Dick test packs B.4.2 Health care facility–prepared Bowie-Dick test packs B.5 Recommended practices—Application and frequency of use B.6 Standards B.6.1 International Standards |
| 30 | B.6.2 AAMI standards B.7 Current trends |
| 31 | Annex C International perspectives on PCDs C.1 Introduction C.2 United States and Canadian PCDs |
| 32 | C.3 Australian PCDs C.4 European PCDs C.4.1 EN1422—Ethylene oxide C.4.2 EN867-5—Steam C.5 ISO standard PCDs C.6 Summary |
| 33 | Annex D Development and qualification of the 16-towel PCD used for steam sterilization D.1 Introduction D.2 Survey and preliminary testing |
| 34 | D.3 Validation testing D.3.1 Validation testing in gravity cycles D.3.2 Validation testing in vacuum-assisted cycles |
| 35 | D.4 Direct comparison of the 12 × 12 × 20–inch and 16-towel PCDs |
| 36 | D.5 Summary of round-robin testing |
| 37 | D.6 Supplemental data for steam-flush pressure-pulse cycles |
| 41 | Annex E Development and qualification of the routine PCD used for ethylene oxide sterilization E.1 Introduction E.2 Materials and methods E.2.1 Test strategy E.2.2 Test laboratories E.2.3 Sterilization equipment E.2.4 PCD components and assembly E.2.5 Exposure conditions |
| 42 | E.2.6 Test procedure E.2.7 Data collected E.3 Results |
| 43 | Annex F Historical perspective |
| 45 | Annex G Bibliography |
