BS EN ISO 11137-2:2015
$215.11
Sterilization of health care products. Radiation – Establishing the sterilization dose
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 84 |
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Foreword Table — Correlation between normative references and dated EN and ISO standards Endorsement notice |
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC |
| 6 | Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Table ZB.1 — Correspondence between this European Standard and EU Directive 93/42/EEC |
| 7 | Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC |
| 11 | Foreword |
| 12 | Introduction |
| 13 | Section sec_1 Section sec_2 Section sec_3 Section sec_3.1 Section sec_3.1.1 Section sec_3.1.2 1 Scope 2 Normative references 3 Terms, definitions, and abbreviated terms 3.1 Terms and definitions |
| 14 | Section sec_3.1.3 Section sec_3.1.4 Section sec_3.1.5 Section sec_3.1.6 Section sec_3.1.7 Section sec_3.1.8 Section sec_3.1.9 Section sec_3.1.10 Section sec_3.1.11 Section sec_3.1.12 Section sec_3.1.13 |
| 15 | Section sec_3.1.14 Section sec_3.1.15 Section sec_3.2 Section sec_3.2.1 Section sec_3.2.2 Section sec_3.2.3 Section sec_3.2.4 Section sec_3.2.5 Section sec_3.2.6 Section sec_3.2.7 Section sec_3.2.8 3.2 Abbreviated terms |
| 16 | Section sec_3.2.9 Section sec_3.2.10 Section sec_3.2.11 Section sec_3.2.12 Section sec_3.2.13 Section sec_4 Section sec_4.1 Section sec_4.2 Section sec_4.2.1 4 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing 4.1 General 4.2 Defining product families |
| 17 | Section sec_4.2.2 Section sec_4.2.3 Section sec_4.2.4 Section sec_4.3 Section sec_4.3.1 Section sec_4.3.1.1 Section sec_4.3.1.2 Section sec_4.3.1.3 4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit |
| 18 | Section sec_4.3.2 Section sec_4.3.3 Section sec_4.3.4 Section sec_4.4 Section sec_4.4.1 Section sec_4.4.2 4.4 Maintaining product families |
| 19 | Section sec_4.4.3 Section sec_4.5 Section sec_5 Section sec_5.1 Section sec_5.1.1 Table tab_1 4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family 5 Selection and testing of product for establishing the sterilization dose 5.1 Nature of product |
| 20 | Section sec_5.1.2 Section sec_5.2 Section sec_5.2.1 Section sec_5.2.2 Section sec_5.2.3 Table tab_2 Section sec_5.2.4 Section sec_5.2.5 Section sec_5.2.6 5.2 Sample item portion (SIP) |
| 21 | Section sec_5.3 Section sec_5.3.1 Section sec_5.3.2 Section sec_5.4 Section sec_5.4.1 Section sec_5.4.2 Section sec_5.5 Section sec_5.5.1 Section sec_5.5.2 Section sec_5.5.3 Section sec_6 Section sec_6.1 5.3 Manner of sampling 5.4 Microbiological testing 5.5 Irradiation 6 Methods of dose establishment |
| 22 | Section sec_6.2 Section sec_6.3 Section sec_7 Section sec_7.1 7 Method 1: dose setting using bioburden information 7.1 Rationale |
| 23 | Table tab_3 Table tab_4 Section sec_7.2 Section sec_7.2.1 Section sec_7.2.2 Section sec_7.2.2.1 Section sec_7.2.2.2 Section sec_7.2.3 Section sec_7.2.3.1 Section sec_7.2.3.2 7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches |
| 24 | Section sec_7.2.3.3 Section sec_7.2.4 Section sec_7.2.5 Section sec_7.2.5.1 Section sec_7.2.5.2 Section sec_7.2.5.3 |
| 25 | Section sec_7.2.6 Section sec_7.2.6.1 Section sec_7.2.6.2 Section sec_7.2.7 Section sec_7.2.7.1 Section sec_7.2.7.2 |
| 26 | Table tab_5 |
| 27 | Table tab_5___1 |
| 28 | Table tab_5___2 |
| 29 | Table tab_5___3 Section sec_7.3 Section sec_7.3.1 7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch |
| 30 | Section sec_7.3.2 Section sec_7.3.3 Section sec_7.3.3.1 Section sec_7.3.3.2 Section sec_7.3.4 Section sec_7.3.4.1 Section sec_7.3.4.2 Section sec_7.3.5 Section sec_7.3.6 Section sec_7.3.6.1 Section sec_7.3.6.2 |
| 31 | Section sec_7.3.6.3 Section sec_7.3.7 Section sec_7.3.7.1 Section sec_7.3.7.2 Section sec_7.3.8 Section sec_7.3.8.1 Section sec_7.3.8.2 Section sec_7.4 7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches |
| 32 | Table tab_6 Section sec_8 Section sec_8.1 8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor 8.1 Rationale |
| 33 | Section sec_8.2 Section sec_8.2.1 Section sec_8.2.2 Section sec_8.2.2.1 Section sec_8.2.2.2 Section sec_8.2.3 Section sec_8.2.3.1 Section sec_8.2.3.1.1 Section sec_8.2.3.1.2 Section sec_8.2.3.1.3 8.2 Procedure for Method 2A |
| 34 | Section sec_8.2.3.2 Section sec_8.2.3.2.1 Section sec_8.2.3.2.2 Table tab_7 Section sec_8.2.3.2.3 Section sec_8.2.3.3 Section sec_8.2.3.3.1 Section sec_8.2.3.3.2 Section sec_8.2.3.3.3 |
| 35 | Section sec_8.2.3.4 Section sec_8.2.4 Section sec_8.2.4.1 Section sec_8.2.4.2 Section sec_8.2.5 |
| 36 | Section sec_8.2.6 Section sec_8.2.6.1 Section sec_8.2.6.2 Section sec_8.2.6.3 Section sec_8.3 Section sec_8.3.1 Section sec_8.3.1.1 8.3 Procedure for Method 2B |
| 37 | Section sec_8.3.1.2 Section sec_8.3.2 Section sec_8.3.2.1 Section sec_8.3.2.2 Section sec_8.3.3 Section sec_8.3.3.1 Section sec_8.3.3.1.1 Section sec_8.3.3.1.2 Section sec_8.3.3.1.3 Section sec_8.3.3.2 Section sec_8.3.3.2.1 |
| 38 | Section sec_8.3.3.2.2 Table tab_8 Section sec_8.3.3.2.3 Section sec_8.3.3.3 Section sec_8.3.3.3.1 Section sec_8.3.3.3.2 Section sec_8.3.3.3.3 Section sec_8.3.3.4 |
| 39 | Section sec_8.3.4 Section sec_8.3.4.1 Section sec_8.3.4.2 Section sec_8.3.5 Section sec_8.3.6 Section sec_8.3.6.1 |
| 40 | Section sec_8.3.6.2 Section sec_8.3.6.3 Section sec_9 Section sec_9.1 9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose 9.1 Rationale |
| 41 | Section sec_9.2 Section sec_9.2.1 Section sec_9.2.1.1 Section sec_9.2.1.2 Section sec_9.2.1.3 Section sec_9.2.2 Section sec_9.2.3 Section sec_9.2.3.1 Section sec_9.2.3.2 Section sec_9.2.3.3 9.2 Procedure for Method VDmax25 for multiple production batches |
| 42 | Section sec_9.2.4 |
| 43 | Table tab_9 |
| 44 | Table tab_9___1 Section sec_9.2.5 Section sec_9.2.5.1 Section sec_9.2.5.2 |
| 45 | Section sec_9.2.5.3 Section sec_9.2.6 Section sec_9.2.6.1 Section sec_9.2.6.2 Section sec_9.2.6.3 Section sec_9.2.7 Section sec_9.2.7.1 Section sec_9.2.7.2 Section sec_9.2.7.3 Section sec_9.2.7.3.1 |
| 46 | Section sec_9.2.7.3.2 Section sec_9.2.7.4 Section sec_9.2.7.4.1 Section sec_9.2.7.4.2 Section sec_9.3 Section sec_9.3.1 Section sec_9.3.2 Section sec_9.3.2.1 Section sec_9.3.2.2 Section sec_9.3.2.3 Section sec_9.3.3 9.3 Procedure for Method VDmax25 for a single production batch |
| 47 | Section sec_9.3.4 Section sec_9.3.4.1 Section sec_9.3.4.2 Section sec_9.3.5 Section sec_9.3.6 Section sec_9.3.6.1 Section sec_9.3.6.2 Section sec_9.3.6.3 Section sec_9.3.7 Section sec_9.3.7.1 |
| 48 | Section sec_9.3.7.2 Section sec_9.3.7.3 Section sec_9.3.8 Section sec_9.3.8.1 Section sec_9.3.8.2 Section sec_9.3.8.3 Section sec_9.3.8.3.1 Section sec_9.3.8.3.2 Section sec_9.3.8.4 Section sec_9.3.8.4.1 |
| 49 | Section sec_9.3.8.4.2 Section sec_9.4 Section sec_9.4.1 Section sec_9.4.1.1 Section sec_9.4.1.2 Section sec_9.4.1.3 Section sec_9.4.2 Section sec_9.4.3 Section sec_9.4.3.1 Section sec_9.4.3.2 Section sec_9.4.3.3 9.4 Procedure for Method VDmax15 for multiple production batches |
| 50 | Section sec_9.4.4 Table tab_10 Section sec_9.4.5 Section sec_9.4.5.1 Section sec_9.4.5.2 Section sec_9.4.5.3 |
| 51 | Section sec_9.4.6 Section sec_9.4.6.1 Section sec_9.4.6.2 Section sec_9.4.6.3 Section sec_9.4.7 Section sec_9.4.7.1 Section sec_9.4.7.2 Section sec_9.4.7.3 Section sec_9.4.7.3.1 |
| 52 | Section sec_9.4.7.3.2 Section sec_9.4.7.4 Section sec_9.4.7.4.1 Section sec_9.4.7.4.2 Section sec_9.5 Section sec_9.5.1 Section sec_9.5.2 Section sec_9.5.2.1 Section sec_9.5.2.2 Section sec_9.5.2.3 Section sec_9.5.3 Section sec_9.5.4 Section sec_9.5.4.1 Section sec_9.5.4.2 9.5 Procedure for Method VDmax15 for a single production batch |
| 53 | Section sec_9.5.5 Section sec_9.5.6 Section sec_9.5.6.1 Section sec_9.5.6.2 Section sec_9.5.6.3 Section sec_9.5.7 Section sec_9.5.7.1 Section sec_9.5.7.2 Section sec_9.5.7.3 |
| 54 | Section sec_9.5.8 Section sec_9.5.8.1 Section sec_9.5.8.2 Section sec_9.5.8.3 Section sec_9.5.8.3.1 Section sec_9.5.8.3.2 Section sec_9.5.8.4 Section sec_9.5.8.4.1 Section sec_9.5.8.4.2 |
| 55 | Section sec_10 Section sec_10.1 Section sec_10.2 Section sec_10.2.1 Section sec_10.2.1.1 Section sec_10.2.1.2 Section sec_10.2.2 Section sec_10.2.3 Section sec_10.2.4 Section sec_10.2.4.1 10 Sterilization dose audit 10.1 Purpose and frequency 10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A, or Method 2B |
| 56 | Section sec_10.2.4.2 Section sec_10.2.5 Section sec_10.2.5.1 Section sec_10.2.5.2 |
| 57 | Section sec_10.2.5.3 Section sec_10.2.6 Section sec_10.2.6.1 Section sec_10.2.6.2 Section sec_10.2.6.3 |
| 58 | Section sec_10.2.6.4 Section sec_10.2.6.5 Section sec_10.3 Section sec_10.3.1 Section sec_10.3.1.1 Section sec_10.3.1.2 Section sec_10.3.2 10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15 |
| 59 | Section sec_10.3.3 Section sec_10.3.3.1 Section sec_10.3.3.2 Section sec_10.3.4 Section sec_10.3.4.1 Section sec_10.3.4.2 Section sec_10.3.5 Section sec_10.3.5.1 Section sec_10.3.5.2 Section sec_10.3.5.3 |
| 60 | Section sec_10.3.6 Section sec_10.3.6.1 Section sec_10.3.6.1.1 Section sec_10.3.6.1.2 Section sec_10.3.6.2 Section sec_10.3.6.3 Section sec_10.3.6.3.1 |
| 61 | Section sec_10.3.6.3.2 Section sec_10.3.6.4 Section sec_10.3.7 Section sec_10.3.7.1 |
| 62 | Table tab_11 |
| 63 | Table tab_11___1 Section sec_10.3.7.2 |
| 64 | Table tab_12 Section sec_10.4 Section sec_11 Section sec_11.1 Table tab_13 10.4 Failure of a sterilization dose audit 11 Worked examples 11.1 Worked examples for Method 1 |
| 65 | Table tab_14 |
| 66 | Table tab_15 Section sec_11.2 Section sec_11.2.1 11.2 Worked examples for Method 2 |
| 67 | Section sec_11.2.2 Section sec_11.2.2.1 Section sec_11.2.2.1.1 Section sec_11.2.2.1.2 Table tab_16 Section sec_11.2.2.2 Table tab_17 Table tab_18 |
| 68 | Section sec_11.2.2.3 Table tab_19 Section sec_11.2.2.4 Table tab_20 |
| 69 | Section sec_11.2.3 Section sec_11.2.3.1 Section sec_11.2.3.1.1 Section sec_11.2.3.1.2 Table tab_21 Section sec_11.2.3.2 |
| 70 | Table tab_22 Table tab_23 Section sec_11.2.3.3 Table tab_24 |
| 71 | Section sec_11.2.3.4 Table tab_25 |
| 72 | Section sec_11.2.4 Section sec_11.2.4.1 Section sec_11.2.4.1.1 Section sec_11.2.4.1.2 Table tab_26 Section sec_11.2.4.2 Table tab_27 Table tab_28 |
| 73 | Section sec_11.2.4.3 Table tab_29 Section sec_11.2.4.4 Table tab_30 |
| 74 | Section sec_11.3 Table tab_31 11.3 Worked examples for Method VDmax |
| 75 | Table tab_32 |
| 76 | Section sec_11.4 Table tab_33 Section sec_11.5 11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose 11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose |
| 77 | Table tab_34 Section sec_11.6 Table tab_35 11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25 |
| 79 | Reference ref_1 Reference ref_2 Reference ref_3 Reference ref_4 Reference ref_5 Reference ref_6 Reference ref_7 Reference ref_8 Reference ref_9 Reference ref_10 Reference ref_11 Reference ref_12 Reference ref_13 Reference ref_14 Reference ref_15 Reference ref_16 Reference ref_17 Reference ref_18 Reference ref_19 Reference ref_20 Bibliography |
| 80 | Reference ref_21 |
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BS EN ISO 11137-2:2015+A1:2023
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