{"id":198310,"date":"2024-10-19T12:37:28","date_gmt":"2024-10-19T12:37:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir17665-3-2014-ra-2016\/"},"modified":"2024-10-25T05:10:33","modified_gmt":"2024-10-25T05:10:33","slug":"aami-tir17665-3-2014-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir17665-3-2014-ra-2016\/","title":{"rendered":"AAMI TIR17665 3 2014 RA 2016"},"content":{"rendered":"

This Technical Specification provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/
\nISO
\nTIR17665-3:2014,
\nSterilization of health
\ncare products \u2014 Moist
\nHeat \u2014 Guidance on the
\ndesignation of a medical
\nproduct to a product family
\nand processing category
\nfor steam sterilization <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
8<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
12<\/td>\nBackground of ANSI\/AAMI adoption of ISO\/TS 17665-3:2013 <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Classification
4.1 General attributes
Table 1 \u2014 General attributes
4.2 Detailed attributes <\/td>\n<\/tr>\n
17<\/td>\n4.2.1 Design
Table 2 \u2014 Design
4.2.2 Material <\/td>\n<\/tr>\n
18<\/td>\nTable 3 \u2014 Materials
4.2.3 Weight
Table 4 \u2014 Weight <\/td>\n<\/tr>\n
19<\/td>\n4.2.4 Sterile barrier system and\/or packaging system
Table 5 \u2014 Sterile barrier system and\/or packaging system
5 Product family (pf) <\/td>\n<\/tr>\n
20<\/td>\n5.1 Example 1 \u2014 pf 1
5.2 Example 2 \u2014 pf 24 <\/td>\n<\/tr>\n
21<\/td>\n5.3 Example 3 \u2014 pf 27 <\/td>\n<\/tr>\n
22<\/td>\nTable 6 \u2014 Product families <\/td>\n<\/tr>\n
23<\/td>\n6 Processing category
7 Sterilization process parameters
8 Additional considerations
8.1 Services
8.2 Process selection <\/td>\n<\/tr>\n
25<\/td>\nAnnex A: Process parameters
Figure A.1 \u2014 Performance requirements: Small load test <\/td>\n<\/tr>\n
27<\/td>\nAnnex B: Characterization of a procedure set \u2014 Examples
B.1 Assessment\/extraction set (oral)
B.1.1 General
Figure B.1 \u2014 Assessment\/extraction set <\/td>\n<\/tr>\n
28<\/td>\nTable B.2 \u2014 Content of assessment\/extraction set
Table B.3 \u2014 Analysis: assessment\/extraction set <\/td>\n<\/tr>\n
29<\/td>\nB.1.2 Product family
Table B.4 \u2014 Product family \u2014 Classification based on estimates: Assessment\/extraction set
B.2 Cystoscope, bridge and tap set
B.2.1 General <\/td>\n<\/tr>\n
30<\/td>\nFigure B.2 \u2014 Cystoscope, bridge and tap set (22 FG)
Table B.5 \u2014 Content of cystoscope, bridge and tap set (22 FG)
Table B.6 \u2014 Analysis: cystoscope, bridge and tap set (22 FG) <\/td>\n<\/tr>\n
31<\/td>\nB.2.2 Product family
Table B.7 \u2014 Product family \u2014 Classification based on estimates: Cystoscope, bridge and tap set (22 FG)
B.3 Cataract ophthalmic No. 6 set
B.3.1 General <\/td>\n<\/tr>\n
32<\/td>\nFigure B.3 \u2014 Cataract ophthalmic No. 6 set
Table B.8 \u2014 Content of cataract ophthalmic No. 6 set <\/td>\n<\/tr>\n
33<\/td>\nTable B.9 \u2014 Analysis: Cataract ophthalmic No. 6 set
B.3.2 Product family
Table B.10 \u2014 Product family \u2014 Classification based on estimates: Cataract ophthalmic No. 6 set
B.4 General orthopaedic set
B.4.1 General <\/td>\n<\/tr>\n
34<\/td>\nFigure B.4 \u2014 General orthopaedic set
Table B.11 \u2014 Content of general orthopaedic set <\/td>\n<\/tr>\n
35<\/td>\nTable B.12 \u2014 Analysis -general orthopaedic set
B.4.2 Product family <\/td>\n<\/tr>\n
36<\/td>\nB.5 General laparoscopy set
B.5.1 General <\/td>\n<\/tr>\n
37<\/td>\nFigure B.5 \u2014 General laparoscopy set
Table B.14 \u2014 Content of general laparoscopy set <\/td>\n<\/tr>\n
38<\/td>\nTable B.15 \u2014 General laparoscopy set
B.5.2 Product family
Table B.16 \u2014 Product family \u2014 Classification based on estimates: General laparoscopy set <\/td>\n<\/tr>\n
39<\/td>\nB.6 LCS knee set (1 of 6)
B.6.1 General
Figure B.6 \u2014 LCS knee (set 1 of 6) <\/td>\n<\/tr>\n
40<\/td>\nTable B.17 \u2014 Contents: LCS knee (set 1 of 6)
Table B.18 \u2014 Product family \u2014 Classification based on estimates: LCS knee (set 1 of 6) <\/td>\n<\/tr>\n
41<\/td>\nB.6.2 Product family
Table B.19 \u2014 Product family \u2014 Classification based on estimates: LCS knee (set 1 of 6)
B.7 Femur repair and nail extraction set
B.7.1 General <\/td>\n<\/tr>\n
42<\/td>\nFigure B.7 \u2014 Femur repair and nail extraction set
Table B.20 \u2014 Content: Femur repair and nail extraction set <\/td>\n<\/tr>\n
43<\/td>\nTable B.21 \u2014 Analysis: Femur repair and nail extraction set
B.7.2 Product family <\/td>\n<\/tr>\n
45<\/td>\nAnnex C: Designating a processing category <\/td>\n<\/tr>\n
47<\/td>\nAnnex D: Processing categories \u2014 Examples
D.1 General instruments
Figure D.1 \u2014 Processing category: General instruments
D.1.1 Assessment of family member 1 <\/td>\n<\/tr>\n
48<\/td>\nTable D.1 \u2014 Content: Family member 1
Table D.2 \u2014 Analysis: Family member set 1
D.1.2 Product family <\/td>\n<\/tr>\n
49<\/td>\nTable D.3 \u2014 Product family \u2014 Classification based on estimates: Family member 1
D.1.3 Assessment of family member 2
Table D.4 \u2014 Content: Family member 2 <\/td>\n<\/tr>\n
50<\/td>\nTable D.5 \u2014 Analysis: Family member set 2
D.1.4 Product family
Table D.6 \u2014 Product family classification based on estimates: family member 2
D.1.5 Assessment of family member 3 <\/td>\n<\/tr>\n
51<\/td>\nTable D.7 \u2014 Content: Family member 3
Table D.8 \u2014 Analysis: Family member set 3
D.1.6 Product family <\/td>\n<\/tr>\n
52<\/td>\nTable D.9 \u2014 Product family classification based on estimates: family member 3
D.1.7 Assessment of family member 4
Table D.10 \u2014 Content: Family member 4
Table D.11 \u2014 Analysis: Family member set 4 <\/td>\n<\/tr>\n
53<\/td>\nD.1.8 Product family
Table D.12 \u2014 Product family \u2014 Classification based on estimates: Family member 4
D.1.9 Assessment of family member 5 <\/td>\n<\/tr>\n
54<\/td>\nTable D.13 \u2014 Content: Family member 5
Table D.14 \u2014 Analysis: Family member 5
D.1.10 Product family
Table D.15 \u2014 Product family \u2014 Classification based on estimates: Family member 5 <\/td>\n<\/tr>\n
55<\/td>\nD.1.11 Master product
Table D.16 \u2014 Content: Family member 6 (master product)
Table D.17 \u2014 Analysis \u2014 Family member set 6: Master product <\/td>\n<\/tr>\n
56<\/td>\nD.1.12 Product family
Table D.18 \u2014 Product family \u2014 Classification based on estimates \u2014 Master product: Family member set 6
D.2 Implant sets and complex orthopaedic sets <\/td>\n<\/tr>\n
57<\/td>\nFigure D.2 \u2014 Processing category: Implant sets
Table D.19 \u2014 Assessment \u2014 Family member 1: Tibial plates <\/td>\n<\/tr>\n
58<\/td>\nTable D.20 \u2014 Assessment \u2014 Family member 2: Cannulated screw set
Table D.21 \u2014 Assessment \u2014 Family member 3: Bone screw and instrument set <\/td>\n<\/tr>\n
59<\/td>\nTable D.22 \u2014 Assessment \u2014 Family member 4 \u2014 Master product: Fragment instruments, plates and screws set
Figure D.3 \u2014 Processing category \u2013 complex orthopaedic sets <\/td>\n<\/tr>\n
60<\/td>\nTable D.23 \u2014 Assessment \u2014 Family member 1: ACL Instrument set
Table D.24 \u2014 Assessment \u2014 Family member 2: Revision reamers <\/td>\n<\/tr>\n
61<\/td>\nTable D.25 \u2014 Assessment \u2014 Family member 3: Cup screw instrument set <\/td>\n<\/tr>\n
62<\/td>\nTable D.26 \u2014 Assessment \u2014 Family member 4 \u2014 Master product: Hip core instrument set <\/td>\n<\/tr>\n
63<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR17665-3:2014\/(R)2016 – Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n65<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198315,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198310","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\/198310","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\/198315"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198310"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198310"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}