{"id":279491,"date":"2024-10-19T18:51:55","date_gmt":"2024-10-19T18:51:55","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11137-22015\/"},"modified":"2024-10-25T15:25:49","modified_gmt":"2024-10-25T15:25:49","slug":"bs-en-iso-11137-22015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11137-22015\/","title":{"rendered":"BS EN ISO 11137-2:2015"},"content":{"rendered":"

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\u22126<\/sup>. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.<\/p>\n

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nForeword
Table \u2014 Correlation between normative references and dated EN and ISO standards
Endorsement notice <\/td>\n<\/tr>\n
5<\/td>\nAnnex 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 \u2014 Correspondence between this European Standard and Directive 90\/385\/EEC <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on medical devices
Table ZB.1 \u2014 Correspondence between this European Standard and EU Directive 93\/42\/EEC <\/td>\n<\/tr>\n
7<\/td>\nAnnex 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 \u2014 Correspondence between this European Standard and Directive 98\/79\/EC <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\nSection sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.1.1
Section sec_3.1.2
1\tScope
2\tNormative references
3\tTerms, definitions, and abbreviated terms
3.1\tTerms and definitions <\/td>\n<\/tr>\n
14<\/td>\nSection 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 <\/td>\n<\/tr>\n
15<\/td>\nSection 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\tAbbreviated terms <\/td>\n<\/tr>\n
16<\/td>\nSection 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\tDefinition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing
4.1\tGeneral
4.2\tDefining product families <\/td>\n<\/tr>\n
17<\/td>\nSection 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\tDesignation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit <\/td>\n<\/tr>\n
18<\/td>\nSection 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\tMaintaining product families <\/td>\n<\/tr>\n
19<\/td>\nSection 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\tEffect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family
5\tSelection and testing of product for establishing the sterilization dose
5.1\tNature of product <\/td>\n<\/tr>\n
20<\/td>\nSection 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\tSample item portion (SIP) <\/td>\n<\/tr>\n
21<\/td>\nSection 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\tManner of sampling
5.4\tMicrobiological testing
5.5\tIrradiation
6\tMethods of dose establishment <\/td>\n<\/tr>\n
22<\/td>\nSection sec_6.2
Section sec_6.3
Section sec_7
Section sec_7.1
7\tMethod\u00a01: dose setting using bioburden information
7.1\tRationale <\/td>\n<\/tr>\n
23<\/td>\nTable 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\tProcedure for Method\u00a01 for product with an average bioburden greater than or equal to\u00a01,0 for multiple production batches <\/td>\n<\/tr>\n
24<\/td>\nSection 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 <\/td>\n<\/tr>\n
25<\/td>\nSection 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 <\/td>\n<\/tr>\n
26<\/td>\nTable tab_5 <\/td>\n<\/tr>\n
27<\/td>\nTable tab_5___1 <\/td>\n<\/tr>\n
28<\/td>\nTable tab_5___2 <\/td>\n<\/tr>\n
29<\/td>\nTable tab_5___3
Section sec_7.3
Section sec_7.3.1
7.3\tProcedure for Method\u00a01 for product with an average bioburden greater than or equal to\u00a01,0 for a single production batch <\/td>\n<\/tr>\n
30<\/td>\nSection 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 <\/td>\n<\/tr>\n
31<\/td>\nSection 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\tProcedure for Method\u00a01 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches <\/td>\n<\/tr>\n
32<\/td>\nTable tab_6
Section sec_8
Section sec_8.1
8\tMethod\u00a02: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
8.1\tRationale <\/td>\n<\/tr>\n
33<\/td>\nSection 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\tProcedure for Method\u00a02A <\/td>\n<\/tr>\n
34<\/td>\nSection 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 <\/td>\n<\/tr>\n
35<\/td>\nSection 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 <\/td>\n<\/tr>\n
36<\/td>\nSection 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\tProcedure for Method\u00a02B <\/td>\n<\/tr>\n
37<\/td>\nSection 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 <\/td>\n<\/tr>\n
38<\/td>\nSection 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 <\/td>\n<\/tr>\n
39<\/td>\nSection 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 <\/td>\n<\/tr>\n
40<\/td>\nSection sec_8.3.6.2
Section sec_8.3.6.3
Section sec_9
Section sec_9.1
9\tMethod VDmax\u00a0\u2014 Substantiation of 25\u00a0kGy or 15\u00a0kGy as the sterilization dose
9.1\tRationale <\/td>\n<\/tr>\n
41<\/td>\nSection 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\tProcedure for Method VDmax25 for multiple production batches <\/td>\n<\/tr>\n
42<\/td>\nSection sec_9.2.4 <\/td>\n<\/tr>\n
43<\/td>\nTable tab_9 <\/td>\n<\/tr>\n
44<\/td>\nTable tab_9___1
Section sec_9.2.5
Section sec_9.2.5.1
Section sec_9.2.5.2 <\/td>\n<\/tr>\n
45<\/td>\nSection 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 <\/td>\n<\/tr>\n
46<\/td>\nSection 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\tProcedure for Method VDmax25 for a single production batch <\/td>\n<\/tr>\n
47<\/td>\nSection 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 <\/td>\n<\/tr>\n
48<\/td>\nSection 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 <\/td>\n<\/tr>\n
49<\/td>\nSection 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\tProcedure for Method VDmax15 for multiple production batches <\/td>\n<\/tr>\n
50<\/td>\nSection 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 <\/td>\n<\/tr>\n
51<\/td>\nSection 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 <\/td>\n<\/tr>\n
52<\/td>\nSection 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\tProcedure for Method VDmax15 for a single production batch <\/td>\n<\/tr>\n
53<\/td>\nSection 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 <\/td>\n<\/tr>\n
54<\/td>\nSection 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 <\/td>\n<\/tr>\n
55<\/td>\nSection 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\tSterilization dose audit
10.1\tPurpose and frequency
10.2\tProcedure for auditing a sterilization dose established using Method\u00a01, Method\u00a02A, or Method\u00a02B <\/td>\n<\/tr>\n
56<\/td>\nSection sec_10.2.4.2
Section sec_10.2.5
Section sec_10.2.5.1
Section sec_10.2.5.2 <\/td>\n<\/tr>\n
57<\/td>\nSection 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 <\/td>\n<\/tr>\n
58<\/td>\nSection 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\tProcedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15 <\/td>\n<\/tr>\n
59<\/td>\nSection 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 <\/td>\n<\/tr>\n
60<\/td>\nSection 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 <\/td>\n<\/tr>\n
61<\/td>\nSection sec_10.3.6.3.2
Section sec_10.3.6.4
Section sec_10.3.7
Section sec_10.3.7.1 <\/td>\n<\/tr>\n
62<\/td>\nTable tab_11 <\/td>\n<\/tr>\n
63<\/td>\nTable tab_11___1
Section sec_10.3.7.2 <\/td>\n<\/tr>\n
64<\/td>\nTable tab_12
Section sec_10.4
Section sec_11
Section sec_11.1
Table tab_13
10.4\tFailure of a sterilization dose audit
11\tWorked examples
11.1\tWorked examples for Method\u00a01 <\/td>\n<\/tr>\n
65<\/td>\nTable tab_14 <\/td>\n<\/tr>\n
66<\/td>\nTable tab_15
Section sec_11.2
Section sec_11.2.1
11.2\tWorked examples for Method\u00a02 <\/td>\n<\/tr>\n
67<\/td>\nSection 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 <\/td>\n<\/tr>\n
68<\/td>\nSection sec_11.2.2.3
Table tab_19
Section sec_11.2.2.4
Table tab_20 <\/td>\n<\/tr>\n
69<\/td>\nSection 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 <\/td>\n<\/tr>\n
70<\/td>\nTable tab_22
Table tab_23
Section sec_11.2.3.3
Table tab_24 <\/td>\n<\/tr>\n
71<\/td>\nSection sec_11.2.3.4
Table tab_25 <\/td>\n<\/tr>\n
72<\/td>\nSection 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 <\/td>\n<\/tr>\n
73<\/td>\nSection sec_11.2.4.3
Table tab_29
Section sec_11.2.4.4
Table tab_30 <\/td>\n<\/tr>\n
74<\/td>\nSection sec_11.3
Table tab_31
11.3\tWorked examples for Method VDmax <\/td>\n<\/tr>\n
75<\/td>\nTable tab_32 <\/td>\n<\/tr>\n
76<\/td>\nSection sec_11.4
Table tab_33
Section sec_11.5
11.4\tWorked example of a sterilization dose audit for a dose established using Method\u00a01, the findings from which necessitated augmentation of the sterilization dose
11.5\tWorked example of a sterilization dose audit for a dose established using Method\u00a02A, the findings from which necessitated augmentation of the sterilization dose <\/td>\n<\/tr>\n
77<\/td>\nTable tab_34
Section sec_11.6
Table tab_35
11.6\tWorked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25 <\/td>\n<\/tr>\n
79<\/td>\nReference 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 <\/td>\n<\/tr>\n
80<\/td>\nReference ref_21 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products. Radiation – Establishing the sterilization dose<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2015<\/td>\n84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279496,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279491","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/279491","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/279496"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279491"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279491"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279491"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}