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BS EN ISO 11137-2:2015+A1:2023

BS EN ISO 11137-2:2015+A1:2023

$215.11

Sterilization of health care products. Radiation – Establishing the sterilization dose

Published By Publication Date Number of Pages
BSI 2023 88
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PDF Pages PDF Title
2 undefined
8 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
11 Annex ZB (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
17 Foreword
18 Introduction
19 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
20 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
21 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
22 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
23 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
24 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
25 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
26 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)
27 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
28 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
29 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
30 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
31 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
32 Table tab_5
33 Table tab_5___1
34 Table tab_5___2
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 Section sec_9.2.4
49 Table tab_9
50 Table tab_9___1
Section sec_9.2.5
Section sec_9.2.5.1
Section sec_9.2.5.2
51 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
52 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
53 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
54 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
55 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
56 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
57 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
58 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
59 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
60 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
61 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
62 Section sec_10.2.4.2
Section sec_10.2.5
Section sec_10.2.5.1
Section sec_10.2.5.2
63 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
64 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
65 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
66 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
67 Section sec_10.3.6.3.2
Section sec_10.3.6.4
Section sec_10.3.7
Section sec_10.3.7.1
68 Table tab_11
69 Table tab_11___1
Section sec_10.3.7.2
70 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
71 Table tab_14
72 Table tab_15
Section sec_11.2
Section sec_11.2.1
11.2 Worked examples for Method 2
73 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
74 Section sec_11.2.2.3
Table tab_19
Section sec_11.2.2.4
Table tab_20
75 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
76 Table tab_22
Table tab_23
Section sec_11.2.3.3
Table tab_24
77 Section sec_11.2.3.4
Table tab_25
78 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
79 Section sec_11.2.4.3
Table tab_29
Section sec_11.2.4.4
Table tab_30
80 Section sec_11.3
Table tab_31
11.3 Worked examples for Method VDmax
81 Table tab_32
82 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
83 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
85 Reference ref_1
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Bibliography
86 Reference ref_21

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