BS EN ISO 11138-7:2019 – TC:2020 Edition
$280.87
Tracked Changes. Sterilization of health care products. Biological indicators – Guidance for the selection, use and interpretation of results
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 173 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 101 | undefined |
| 103 | European foreword Endorsement notice |
| 106 | Foreword |
| 107 | Introduction |
| 108 | 1 Scope 2 Normative references 3 Terms and definitions |
| 111 | 4 General |
| 113 | 5 Characteristics of biological indicators 5.1 General |
| 114 | 5.2 Test organism suspension for direct inoculation of products 5.3 Inoculated carriers |
| 115 | 5.4 Self-contained biological indicators 6 Selection of supplier 6.1 General |
| 116 | 6.2 Documentation 6.2.1 General |
| 117 | 6.2.2 Manufacturer audit |
| 118 | 7 Biological indicators in process development 7.1 General 7.2 Overkill approach |
| 119 | 7.3 Combined biological indicator and bioburden method |
| 120 | 7.4 Bioburden method 8 Biological indicators in sterilization validation 8.1 General |
| 121 | 8.2 Placement and handling of biological indicators 8.3 Sterilizer qualification 8.4 Performance qualification |
| 122 | 8.5 Review and approval of validation 8.6 Requalification 9 Biological indicators in routine monitoring 9.1 General |
| 123 | 9.2 Placement and handling of biological indicators 9.3 Process challenge device |
| 124 | 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 |
| 125 | 11.2 Nominal population of test organism |
| 126 | 11.3 Resistance determination 11.3.1 General 11.3.2 Survivor curve method 11.3.3 Fraction-negative method |
| 127 | 11.3.4 Survival-kill response characteristics 11.4 z value determination 11.4.1 General 11.4.2 Graphically plotting the z value |
| 128 | 11.4.3 Mathematically calculating the z value |
| 129 | 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 |
| 130 | 11.7 Sterility assurance level calculation 11.8 Test equipment |
| 131 | 12 Culture conditions 12.1 General 12.2 Incubation temperature 12.3 Incubation period |
| 132 | 12.4 Choice of growth medium 13 Third-party considerations 13.1 General |
| 133 | 13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators 13.3 Test equipment 14 Personnel training |
| 134 | 15 Storage and handling 16 Disposal of biological indicators |
| 135 | Annex A (informative) Microbiological inactivation kinetics and enumeration techniques |
| 140 | Annex B (informative) Process challenge devices |
| 141 | Annex C (informative) Formulae for D value determination by fraction-negative method |
| 157 | Annex D (informative) Examples of documentation for biological indicators prepared by the user |
| 161 | Annex E (informative) Calculation of z value |
| 164 | Annex F (informative) D value determination by survivor curve method |
| 168 | Annex G (informative) Survival-kill response characteristics |
| 170 | Bibliography |
Related products
-
BS EN ISO 11137-3:2017 – TC:2020 Edition
Tracked Changes. Sterilization of health care products. Radiation – Guidance on dosimetric aspects of development,…
-
BS EN ISO 18750:2018 – TC:2020 Edition
Tracked Changes. Intelligent transport systems. Co-operative ITS. Local dynamic map Published By Publication Date Number…
