AAMI 11138 7 2019
$140.32
ANSI/AAMI/ISO 11138-7:2019 – Sterilization of health care products-Biological indicators-Part 7: Guidance for the selection, use and interpretation of results
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 74 |
Provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11138-7:2019; Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 8 | Background of AAMI adoption of ISO 11138-7:2019 |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 General |
| 16 | 5 Characteristics of biological indicators 5.1 General |
| 17 | 5.2 Test organism suspension for direct inoculation of products |
| 18 | 5.3 Inoculated carriers 5.4 Self-contained biological indicators |
| 19 | 6 Selection of supplier 6.1 General |
| 20 | 6.2 Documentation 6.2.1 General 6.2.2 Manufacturer audit |
| 21 | 7 Biological indicators in process development 7.1 General |
| 22 | 7.2 Overkill approach |
| 23 | 7.3 Combined biological indicator and bioburden method 7.4 Bioburden method |
| 24 | 8 Biological indicators in sterilization validation 8.1 General 8.2 Placement and handling of biological indicators 8.3 Sterilizer qualification |
| 25 | 8.4 Performance qualification 8.5 Review and approval of validation 8.6 Requalification 9 Biological indicators in routine monitoring 9.1 General |
| 26 | 9.2 Placement and handling of biological indicators 9.3 Process challenge device |
| 27 | 10 Interpretation and acceptance criteria 10.1 General 10.2 Interpretation of results 11 Application of biological indicator standards 11.1 General assessment of biological indicator performance by the user |
| 28 | 11.2 Nominal population of test organism |
| 29 | 11.3 Resistance determination 11.3.1 General 11.3.2 Survivor curve method 11.3.3 Fraction-negative method |
| 30 | 11.3.4 Survival-kill response characteristics 11.4 z value determination 11.4.1 General 11.4.2 Graphically plotting the z value |
| 31 | Figure 1—Graphically plotting the z value 11.4.3 Mathematically calculating the z value |
| 32 | 11.4.4 Correlation coefficient, r, for the z value 11.5 F(T, z) equivalent sterilization value determination 11.6 Establishing spore-log-reduction |
| 33 | 11.7 Sterility assurance level calculation 11.8 Test equipment |
| 34 | 12 Culture conditions 12.1 General 12.2 Incubation temperature 12.3 Incubation period |
| 35 | 12.4 Choice of growth medium 13 Third-party considerations 13.1 General |
| 36 | 13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators Table 1—Minimum samples according to method 13.3 Test equipment 14 Personnel training |
| 37 | 15 Storage and handling 16 Disposal of biological indicators |
| 38 | Annex A (informative) Microbiological inactivation kinetics and enumeration techniques Figure A.1—Examples of relationship between the biological indicator and the product bioburden in a reference microorganism method |
| 39 | Figure A.2—Examples of equivalent biological challenges with preparations of different resistance |
| 40 | Figure A.3—Example of a z value determination (see 11.4) |
| 41 | Figure A.4—Areas for D value determination methods under uniform conditions |
| 42 | Annex B (informative) Process challenge devices B.1 General B.2 Helices B.3 Standard test packs B.4 User’s process challenge devices B.5 Biological test packs |
| 43 | Annex C (informative) Formulae for D value determination by fraction-negative method C.1 Principles C.2 Materials |
| 44 | C.3 Procedure C.3.1 Holcomb-Spearman-Karber Procedure (HSKP) C.3.1.1 Procedure C.3.1.2 Calculations using the HSKP |
| 45 | Table C.1—Examples of data collected for HSKP |
| 47 | C.3.1.3 Example calculations using the HSKP Table C.2—Examples of data with non-constant time intervals and non-constant number of samples |
| 51 | C.3.2 Limited Holcomb-Spearman-Karber Procedure (LHSKP) C.3.2.1 Calculations using the LHSKP Table C.3—Examples of data collected for LHSKP with constant time intervals and constant number of samples |
| 52 | C.3.2.2 Example calculations using the LHSKP Table C.4—Examples of data with constant time intervals and constant number of samples |
| 54 | C.3.3 Stumbo-Murphy-Cochran Procedure (SMCP) C.3.3.1 Procedure |
| 55 | C.3.3.2 Calculations using the SMCP C.3.3.3 Example calculations using the SMCP |
| 56 | Table C.5—Calculations of D value using only one data set in the fraction-negative range |
| 59 | Annex D (informative) Examples of documentation for biological indicators prepared by the user D.1 General D.1.1 Sources of microorganisms Figure D.1—Sources of microorganisms D.1.2 Documentation |
| 60 | D.2 Commercially available suspension D.3 Suspension from a commercially available strain |
| 61 | D.4 Suspension from in-house isolates D.5 Inoculated carriers D.5.1 General D.5.2 Documentation of fluid carrier materials |
| 62 | D.5.3 Documentation of solid carrier materials D.5.4 Documentation of inoculated carriers used for D value determinations |
| 64 | Annex E (informative) Calculation of z value |
| 65 | Table E.1—Examples of data collected for regression analysis Table E.2—Examples of calculations for slope |
| 67 | Annex F (informative) D value determination by survivor curve method F.1 Principle F.2 Materials F.3 Procedure |
| 68 | Table F.1—Examples of regression analysis |
| 69 | Table F.2—Examples of calculations for slope |
| 71 | Annex G (informative) Survival-kill response characteristics G.1 Principle G.2 Materials G.3 Procedure |
| 73 | Bibliography |
