BS EN ISO 11138-7:2019
$215.11
Sterilization of health care products. Biological indicators – Guidance for the selection, use and interpretation of results
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 74 |
This document 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.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 7 | Foreword |
| 8 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 12 | 4 General |
| 14 | 5 Characteristics of biological indicators 5.1 General |
| 15 | 5.2 Test organism suspension for direct inoculation of products 5.3 Inoculated carriers |
| 16 | 5.4 Self-contained biological indicators 6 Selection of supplier 6.1 General |
| 17 | 6.2 Documentation 6.2.1 General |
| 18 | 6.2.2 Manufacturer audit |
| 19 | 7 Biological indicators in process development 7.1 General 7.2 Overkill approach |
| 20 | 7.3 Combined biological indicator and bioburden method |
| 21 | 7.4 Bioburden method 8 Biological indicators in sterilization validation 8.1 General |
| 22 | 8.2 Placement and handling of biological indicators 8.3 Sterilizer qualification 8.4 Performance qualification |
| 23 | 8.5 Review and approval of validation 8.6 Requalification 9 Biological indicators in routine monitoring 9.1 General |
| 24 | 9.2 Placement and handling of biological indicators 9.3 Process challenge device |
| 25 | 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 |
| 26 | 11.2 Nominal population of test organism |
| 27 | 11.3 Resistance determination 11.3.1 General 11.3.2 Survivor curve method 11.3.3 Fraction-negative method |
| 28 | 11.3.4 Survival-kill response characteristics 11.4 z value determination 11.4.1 General 11.4.2 Graphically plotting the z value |
| 29 | 11.4.3 Mathematically calculating the z value |
| 30 | 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 |
| 31 | 11.7 Sterility assurance level calculation 11.8 Test equipment |
| 32 | 12 Culture conditions 12.1 General 12.2 Incubation temperature 12.3 Incubation period |
| 33 | 12.4 Choice of growth medium 13 Third-party considerations 13.1 General |
| 34 | 13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators 13.3 Test equipment 14 Personnel training |
| 35 | 15 Storage and handling 16 Disposal of biological indicators |
| 36 | Annex A (informative) Microbiological inactivation kinetics and enumeration techniques |
| 41 | Annex B (informative) Process challenge devices |
| 42 | Annex C (informative) Formulae for D value determination by fraction-negative method |
| 58 | Annex D (informative) Examples of documentation for biological indicators prepared by the user |
| 62 | Annex E (informative) Calculation of z value |
| 65 | Annex F (informative) D value determination by survivor curve method |
| 69 | Annex G (informative) Survival-kill response characteristics |
| 71 | Bibliography |
Related products
-
BS EN ISO 11138-7:2019 – TC:2020 Edition
Tracked Changes. Sterilization of health care products. Biological indicators – Guidance for the selection, use…
