AAMI 14161 2009 RA 2014
$143.79
ANSI/AAMI/ISO 14161-2009/(R)2014 – Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 84 |
Provides guidance for the selection, use, and interpretation of results from the application of biological indicators in the development, validation, and routine monitoring of sterilization processes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 14161:2009/(R)2014, Sterilization of health care products — Biological indicators —Guidance for the 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 ANSI/AAMI adoption of ISO 14161:2009 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 20 | 4 General |
| 21 | 5 Characteristics of biological indicators 5.1 General |
| 22 | 5.2 Test organism suspension for direct inoculation of products |
| 23 | 5.3 Inoculated carriers 5.4 Self-contained biological indicators |
| 24 | 5.5 Other biological indicators 6 Selection of supplier 6.1 General |
| 25 | 6.2 Documentation 6.2.1 General 6.2.2 Manufacturer audit |
| 26 | 7 Biological indicators in process development 7.1 General |
| 27 | 7.2 Overkill approach |
| 28 | 7.3 Combined biological indicator and bioburden method |
| 29 | 7.4 Bioburden method 8 Biological indicators in sterilization validation 8.1 General 8.2 Placement and handling of biological indicators |
| 30 | 8.3 Sterilizer qualification 8.4 Performance qualification 8.5 Review and approval of validation 8.6 Requalification |
| 31 | 9 Biological indicators in routine monitoring 9.1 General 9.2 Placement and handling of biological indicators |
| 32 | 9.3 Process challenge device (PCD) 10 Results 10.1 General 10.2 Interpretation of results |
| 33 | 11 Application of biological indicator standards 11.1 General assessment of biological indicator performance by the user 11.2 Nominal population of test organism |
| 34 | 11.3 Resistance determination 11.3.1 General |
| 35 | 11.3.2 Survivor curve method 11.3.3 Fraction-negative method |
| 36 | 11.3.4 Survival-kill response characteristics 11.4 z value determination 11.4.1 General |
| 37 | 11.4.2 Graphically plotting the z value 11.4.3 Mathematically calculating the z value |
| 38 | 11.4.4 Correlation coefficient, r, for the z value |
| 39 | 11.5 F(T, z) equivalent sterilization value determination 11.6 Establishing spore-log-reduction (SLR) |
| 40 | 11.7 Sterility assurance level (SAL) calculation 11.8 Test equipment 12 Culture conditions 12.1 General |
| 41 | 12.2 Incubation temperature 12.3 Incubation period 12.4 Choice of growth medium |
| 42 | 13 Third-party requirements 13.1 General |
| 43 | 13.2 Minimum requirements for replicates and total number of biological indicators 13.3 Test equipment |
| 44 | 14 Personnel training 15 Storage and handling 16 Disposal of biological indicators |
| 46 | Annex A Microbiological inactivation kinetics and enumeration techniques |
| 52 | Annex B Process challenge devices B.1 General B.2 Helices B.3 Standard test packs B.4 User’s process challenge devices |
| 53 | B.5 Biological test packs |
| 54 | Annex C Formulae for fraction negative methods for D value calculations (adapted from ISO 11138-1:2006, Annex D) C.1 General C.2 Materials |
| 55 | C.3 Methods C.3.1 Holcomb-Spearman-Karber Procedure (HSKP) C.3.1.1 Introduction C.3.1.2 Calculations using the HSKP |
| 58 | C.3.1.3 Example calculation of the Holcomb-Spearman-Karber Procedure (HSKP) |
| 61 | C.3.2 Limited Holcomb-Spearman-Karber Procedure (LHSKP) C.3.2.1 Calculations using the LHSKP |
| 63 | C.3.2.2 Example calculations of the Limited Holcomb-Spearman-Karber Procedure (LHSKP) |
| 65 | C.3.3 Stumbo-Murphy-Cochran Procedure (SMCP) C.3.3.1 Introduction C.3.3.2 Calculations using the SMCP |
| 66 | C.3.3.3 Example calculations of the Stumbo-Murphy-Cochran Procedure (SMCP) |
| 70 | Annex D Examples of documentation for biological indicators prepared by the user D.1 General D.1.1 Sources of microorganisms D.1.2 Documentation |
| 71 | D.2 Commercially available suspension D.3 Suspension from a commercially available strain |
| 72 | D.4 Suspension from in-house isolates D.5 Inoculated carriers D.5.1 General D.5.2 Documentation of fluid carrier materials |
| 73 | D.5.3 Documentation of solid carrier materials D.5.4 Documentation of inoculated carriers used for D value determinations |
| 75 | Annex E Calculation of z value (adapted from ISO 11138-3:2006, Annex B) |
| 78 | Annex F D value determination by survivor curve method (adapted from ISO 11138-1:2006, Annex C) F.1 General F.2 Materials F.3 Procedure |
| 82 | Annex G Survival-kill response characteristics (adapted from ISO 11138-1:2006, Annex E) G.1 General G.2 Materials G.3 Method |
| 83 | Bibliography |
