{"id":198059,"date":"2024-10-19T12:36:33","date_gmt":"2024-10-19T12:36:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-17-2002-ra-2012\/"},"modified":"2024-10-25T05:09:46","modified_gmt":"2024-10-25T05:09:46","slug":"aami-10993-17-2002-ra-2012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-17-2002-ra-2012\/","title":{"rendered":"AAMI 10993 17 2002 RA 2012"},"content":{"rendered":"

Specifies the method to be used to determine allowable limits for leachable substances in medical devices<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 10993-17:2002\/(R)2012, Biological evaluation of medical devices — Part 17: Methods for the establishment of allowable <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 10993-17:2002 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1\tScope
2\tNormative reference
3\tTerms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4\tGeneral principles for establishing allowable limits <\/td>\n<\/tr>\n
17<\/td>\n5\tEstablishment of tolerable intake (TI) for specific leachable substances
5.1\tGeneral
5.2 Exposure considerations for TI calculation
5.2.1 Data used
5.2.2\tExposure duration considerations <\/td>\n<\/tr>\n
18<\/td>\n5.2.3\tConsiderations of route of exposure
5.3\tCollection and evaluation of data <\/td>\n<\/tr>\n
19<\/td>\n5.4\tSet TI for noncancer endpoints
5.4.1\tGeneral
5.4.2\tDetermination of uncertainty factors
5.4.2.1\tGeneral
5.4.2.2\tUncertainty Factor 1 (UF1)
5.4.2.3\tUncertainty Factor 2 (UF2) <\/td>\n<\/tr>\n
20<\/td>\n5.4.2.4\tUncertainty Factor 3 (UF3)
5.4.3\tDetermination of the modifying factor
5.5\tSet TI for cancer endpoints
5.5.1\tProcedure for carcinogenic leachable substances <\/td>\n<\/tr>\n
21<\/td>\n5.5.2\tOptions for substances that pass the weight-of-evidence test
5.5.3\tProcedure when weight-of-evidence test fails or is equivocal
5.6\tEstablishment of tolerable contact levels (TCLs)
5.6.1\tGeneral
5.6.2\tExposure consideration for TCL calculation
5.6.3\tSet TCL for irritation endpoint
5.6.3.1\tGeneral <\/td>\n<\/tr>\n
22<\/td>\n5.6.3.2\tDetermination of uncertainty factors
5.6.3.3\tDetermination of the TCL modifying factor
5.7\tRisk assessment of mixtures <\/td>\n<\/tr>\n
23<\/td>\n6\tCalculation of tolerable exposure (TE)
6.1\tGeneral
6.2\tExposure population
6.2.1\tBody mass
6.2.2\tDevices specifically intended for use in neonates and children
6.3\tCalculation of utilization factor from intended use pattern
6.3.1\tGeneral <\/td>\n<\/tr>\n
24<\/td>\n6.3.2\tConcomitant exposure factor (CEF)
6.3.3\tProportional exposure factor (PEF) <\/td>\n<\/tr>\n
25<\/td>\n6.4\tTolerable exposure
7\tFeasibility evaluation
8\tBenefit evaluation
9\tAllowable limits <\/td>\n<\/tr>\n
26<\/td>\n10\tReporting requirements <\/td>\n<\/tr>\n
27<\/td>\nAnnex A, Some typical assumptions for biological parameters
A.1\tGeneral
A.2\tAssumptions
A.2.1\tHuman
A.2.2\tRat
A.2.3\tMouse
A.2.4\tHamster <\/td>\n<\/tr>\n
28<\/td>\nA.2.5\tGuinea pig
A.2.6\tDog
A.2.7\tRabbit <\/td>\n<\/tr>\n
29<\/td>\nAnnex B, Risk assessment for mixtures of leachable substances <\/td>\n<\/tr>\n
30<\/td>\nAnnex C, Conversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a
C.1\tIntroduction
C.2\tCalculation of the maximum dose to patient of a leachable substance from a medical device for systemic exposure
C.2.1\tPermanent-contact devices
C.2.2\tProlonged-exposure devices <\/td>\n<\/tr>\n
31<\/td>\nC.2.3\tLimited-exposure devices
C.3\tCalculation of the maximum dose to patient of a substance leachable from medical devices from body-surface contact <\/td>\n<\/tr>\n
32<\/td>\nAnnex D, Risk analysis report
D.1\tGeneral
D.2\tContents <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-17:2002\/(R)2012 – Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2002<\/td>\n33<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198060,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198059","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\/198059","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\/198060"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198059"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198059"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}