{"id":279416,"date":"2024-10-19T18:51:19","date_gmt":"2024-10-19T18:51:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11137-32017\/"},"modified":"2024-10-25T15:25:17","modified_gmt":"2024-10-25T15:25:17","slug":"bs-en-iso-11137-32017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11137-32017\/","title":{"rendered":"BS EN ISO 11137-3:2017"},"content":{"rendered":"

This document gives guidance on meeting the requirements in ISO 11137\u20111 and ISO 11137\u20112 and in ISO\/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms, definitions and symbols
3.1 General <\/td>\n<\/tr>\n
11<\/td>\n3.2 Symbols <\/td>\n<\/tr>\n
12<\/td>\n4 Measurement of dose
4.1 General
4.1.1 Direct and indirect dose measurements
4.1.2 Dosimetry systems
4.1.3 Best estimate of dose <\/td>\n<\/tr>\n
13<\/td>\n4.2 Dosimetry system selection and calibration
4.2.1 General
4.2.2 Selection of dosimetry systems
4.2.3 Calibration of dosimetry systems <\/td>\n<\/tr>\n
14<\/td>\n4.3 Dose measurement uncertainty
4.3.1 General concepts
4.3.2 The Guide to the expression of uncertainty in measurement (GUM) methodology <\/td>\n<\/tr>\n
15<\/td>\n4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty <\/td>\n<\/tr>\n
16<\/td>\n5 Establishing the maximum acceptable dose <\/td>\n<\/tr>\n
17<\/td>\n6 Establishing the sterilization dose <\/td>\n<\/tr>\n
18<\/td>\n7 Installation qualification <\/td>\n<\/tr>\n
19<\/td>\n8 Operational qualification
8.1 General
8.2 Gamma irradiators <\/td>\n<\/tr>\n
21<\/td>\n8.3 Electron beam irradiators <\/td>\n<\/tr>\n
23<\/td>\n8.4 X-ray irradiators <\/td>\n<\/tr>\n
25<\/td>\n9 Performance qualification
9.1 General <\/td>\n<\/tr>\n
26<\/td>\n9.2 Gamma irradiators
9.2.1 Loading pattern <\/td>\n<\/tr>\n
27<\/td>\n9.2.2 Dosimetry <\/td>\n<\/tr>\n
28<\/td>\n9.2.3 Analysis of dose mapping data
9.3 Electron beam irradiators
9.3.1 Loading pattern <\/td>\n<\/tr>\n
30<\/td>\n9.3.2 Dosimetry
9.3.3 Analysis of dose mapping data <\/td>\n<\/tr>\n
31<\/td>\n9.4 X-ray irradiators
9.4.1 Loading pattern <\/td>\n<\/tr>\n
32<\/td>\n9.4.2 Dosimetry <\/td>\n<\/tr>\n
33<\/td>\n9.4.3 Analysis of dose mapping data
10 Routine monitoring and control
10.1 General <\/td>\n<\/tr>\n
34<\/td>\n10.2 Frequency of dose measurements <\/td>\n<\/tr>\n
35<\/td>\nAnnex A (informative) Mathematical modelling <\/td>\n<\/tr>\n
38<\/td>\nAnnex B (informative) Tables of references for dosimetry-related testing during IQ\/OQ\/PQ <\/td>\n<\/tr>\n
41<\/td>\nAnnex C (informative) Tolerances associated with doses used in sterilization dose setting\/substantiation in ISO 11137\u20112 and ISO\/TS 13004 <\/td>\n<\/tr>\n
42<\/td>\nAnnex D (informative) Application of dose measurement uncertainty in setting process target doses <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products. Radiation – Guidance on dosimetric aspects of development, validation and routine control<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2017<\/td>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279420,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279416","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\/279416","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\/279420"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279416"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279416"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}