{"id":435965,"date":"2024-10-20T07:52:17","date_gmt":"2024-10-20T07:52:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11137-3-2017-r2023\/"},"modified":"2024-10-26T14:53:45","modified_gmt":"2024-10-26T14:53:45","slug":"aami-11137-3-2017-r2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11137-3-2017-r2023\/","title":{"rendered":"AAMI 11137 3 2017 R2023"},"content":{"rendered":"

Requirements in regard to dosimetry are given in ISO 11137-1 and ISO 11137-2 and ISO\/TS 13004. This document gives guidance to these requirements.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 11137-3:2017\/(R)2023; Sterilization of health care products\u2014Radiation\u2014Part 3: Guidance on dosimetric aspects of development, validation and routine control <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground on the adoption of ISO 11137-3:2017 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms, definitions and symbols
3.1 General <\/td>\n<\/tr>\n
15<\/td>\n3.2 Symbols <\/td>\n<\/tr>\n
16<\/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
17<\/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 system <\/td>\n<\/tr>\n
18<\/td>\n4.3 Dose measurement uncertainty
4.3.1 General concepts
4.3.2 The GUM methodology <\/td>\n<\/tr>\n
19<\/td>\n4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty <\/td>\n<\/tr>\n
20<\/td>\n5 Establishing the maximum acceptable dose <\/td>\n<\/tr>\n
21<\/td>\n6 Establishing the sterilization dose <\/td>\n<\/tr>\n
22<\/td>\n7 Installation qualification <\/td>\n<\/tr>\n
23<\/td>\n8 Operational qualification
8.1 General
8.2 Gamma irradiators <\/td>\n<\/tr>\n
25<\/td>\n8.3 Electron beam irradiators <\/td>\n<\/tr>\n
26<\/td>\n8.4 X-ray irradiators <\/td>\n<\/tr>\n
28<\/td>\n9 Performance qualification
9.1 General <\/td>\n<\/tr>\n
29<\/td>\n9.2 Gamma
9.2.1 Loading pattern <\/td>\n<\/tr>\n
30<\/td>\n9.2.2 Dosimetry
9.2.2.1 Dosimeter placement <\/td>\n<\/tr>\n
31<\/td>\n9.2.2.2 Replicate dose mapping exercises
9.2.3 Analysis of dose mapping data
9.3 Electron beam
9.3.1 Loading pattern <\/td>\n<\/tr>\n
32<\/td>\n9.3.2 Dosimetry
9.3.2.1 Dosimeter placement <\/td>\n<\/tr>\n
33<\/td>\n9.3.2.2 Replicate dose mapping exercises
9.3.3 Analysis of dose mapping data
9.4 X-ray
9.4.1 Loading pattern <\/td>\n<\/tr>\n
34<\/td>\n9.4.2 Dosimetry
9.4.2.1 Dosimeter placement <\/td>\n<\/tr>\n
35<\/td>\n9.4.2.2 Replicate dose mapping exercises
9.4.3 Analysis of dose mapping data <\/td>\n<\/tr>\n
36<\/td>\n10 Routine monitoring and control
10.1 General
10.2 Frequency of dose measurements <\/td>\n<\/tr>\n
37<\/td>\nAnnex A (informative) Mathematical modelling
A.1 General
A.2 Types of model
A.2.1 General
A.2.2 Point Kernel
A.2.3 Monte Carlo <\/td>\n<\/tr>\n
38<\/td>\nA.3 Use of models
A.3.1 Design of irradiators
A.3.2 Operation of gamma and X-ray irradiators
A.3.3 Operation of electron beam irradiators <\/td>\n<\/tr>\n
39<\/td>\nAnnex B (informative) Tables of references for dosimetry-related testing during IQ\/OQ\/PQ
B.1 Installation qualification
Table B.1\u2014Electron beam and X-ray (not applicable for gamma) <\/td>\n<\/tr>\n
40<\/td>\nB.2 Operational qualification
Table B.2\u2014Gamma, electron beam and X-ray <\/td>\n<\/tr>\n
41<\/td>\nB.3 Performance qualification
Table B.3\u2014Gamma, electron beam and X-ray <\/td>\n<\/tr>\n
42<\/td>\nAnnex C (informative) Tolerances associated with doses used in sterilization dose setting\/substantiation in ISO 11137-2
Table C.1\u2014Tolerances associated with doses used in sterilization dose setting\/substantiation in ISO 11137-2 <\/td>\n<\/tr>\n
43<\/td>\nAnnex D (informative) Application of dose measurement uncertainty in setting process target doses
D.1 General
D.2 Standard uncertainty for setting process target doses (\u03c3process) <\/td>\n<\/tr>\n
44<\/td>\nD.3 Selection of k values
D.4 Radiation sterilization target dose values <\/td>\n<\/tr>\n
45<\/td>\nFigure D.1\u2014Process specifications <\/td>\n<\/tr>\n
46<\/td>\nFigure D.2\u2014Routine dose monitoring at minimum dose location <\/td>\n<\/tr>\n
47<\/td>\nFigure D.3\u2014Routine dose monitoring at a location remote from position of minimum and maximum dose but travelling with the product
D.5 Calculating process target dose values that take uncertainty into account <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11137-3:2017 (R2023) Sterilization Of Health Care Products – Radiation – Part 3: 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
AAMI<\/b><\/a><\/td>\n2017<\/td>\n49<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":435974,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-435965","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/435965","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\/435974"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=435965"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=435965"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=435965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}