{"id":277978,"date":"2024-10-19T18:43:41","date_gmt":"2024-10-19T18:43:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-226752016\/"},"modified":"2024-10-25T15:15:27","modified_gmt":"2024-10-25T15:15:27","slug":"bs-en-iso-226752016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-226752016\/","title":{"rendered":"BS EN ISO 22675:2016"},"content":{"rendered":"
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IMPORTANT This International Standard is suitable<\/i> for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to this International Standard.<\/p>\n<\/blockquote>\n

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WARNING This International Standard is not suitable<\/i> to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.<\/p>\n<\/blockquote>\n

This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.<\/p>\n

This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.<\/p>\n

In addition, this International Standard specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.<\/p>\n

The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.<\/p>\n

The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.<\/p>\n

According to the concept of the tests of this International Standard, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.<\/p>\n

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NOTE 1 The lines of action of the heel and forefoot forces generated by the static test procedure specified in this International Standard approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests specified in ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.<\/p>\n<\/blockquote>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC [OJ L 169] aimed to be covered
Table ZA.1 \u2014 Correspondence between this European standard and Annex I of Directive 93\/42\/EEC [OJ L 169] <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions
4 Designations and symbols of test forces <\/td>\n<\/tr>\n
15<\/td>\n5 Strength and related performance requirements and conditions of use <\/td>\n<\/tr>\n
16<\/td>\n6 Coordinate system and test configurations
6.1 General
6.2 Origin and axes of the coordinate system <\/td>\n<\/tr>\n
17<\/td>\n6.3 Reference points <\/td>\n<\/tr>\n
18<\/td>\n6.4 Test force F
6.5 Line of application of test force F
6.6 Lines of action of resultant reference forces FR1 and FR2
6.7 Longitudinal axis of the foot and effective ankle joint centre
6.7.1 General
6.7.2 Longitudinal axis of the foot <\/td>\n<\/tr>\n
19<\/td>\n6.7.3 Effective ankle-joint centre, CA <\/td>\n<\/tr>\n
20<\/td>\n7 Test loading conditions and test loading levels
7.1 Test loading conditions
7.2 Test loading levels <\/td>\n<\/tr>\n
21<\/td>\n8 Values of test forces, dimensions and cycles <\/td>\n<\/tr>\n
28<\/td>\n9 Compliance
9.1 General <\/td>\n<\/tr>\n
29<\/td>\n9.2 Particular arrangements and requirements concerning the part required to connect an ankle-foot device or foot unit to the remainder of a prosthetic structure
9.2.1 Arrangements for testing
9.2.2 Requirements for claiming compliance
9.3 Number of tests and test samples required to claim compliance with this International Standard <\/td>\n<\/tr>\n
30<\/td>\n9.4 Multiple use of test samples
9.4.1 General
9.4.2 Restriction
9.5 Testing at particular test loading levels not specified in this International Standard <\/td>\n<\/tr>\n
31<\/td>\n10 Test samples
10.1 Selection of test samples
10.1.1 General
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot <\/td>\n<\/tr>\n
32<\/td>\n10.2 Types of test sample
10.2.1 Complete structure
10.2.2 Partial structure
10.3 Preparation of test samples <\/td>\n<\/tr>\n
33<\/td>\n10.4 Identification of test samples
10.5 Alignment of test samples
10.6 Worst-case alignment position of test samples <\/td>\n<\/tr>\n
35<\/td>\n11 Responsibility for test preparation <\/td>\n<\/tr>\n
36<\/td>\n12 Test submission document
12.1 General requirements
12.2 Information required for test samples <\/td>\n<\/tr>\n
37<\/td>\n12.3 Information required for tests
12.3.1 General
12.3.2 For all tests
12.3.3 For the static proof test and the static ultimate strength test
12.3.4 For the static ultimate strength test
12.3.5 For the cyclic test <\/td>\n<\/tr>\n
38<\/td>\n13 Equipment
13.1 General
13.2 End attachments
13.2.1 General
13.2.2 Proof test of end attachments <\/td>\n<\/tr>\n
40<\/td>\n13.3 Jig (optional) <\/td>\n<\/tr>\n
41<\/td>\n13.4 Test equipment
13.4.1 Test equipment to perform static heel and forefoot loading <\/td>\n<\/tr>\n
42<\/td>\n13.4.2 Test equipment to perform cyclic loading <\/td>\n<\/tr>\n
49<\/td>\n14 Accuracy
14.1 General
14.2 Accuracy of equipment
14.3 Accuracy of procedure <\/td>\n<\/tr>\n
50<\/td>\n15 Test principles
15.1 General <\/td>\n<\/tr>\n
51<\/td>\n15.2 Static test procedure
15.3 Cyclic test procedure
16 Test procedures
16.1 Test loading requirements
16.1.1 Preparation for test loading <\/td>\n<\/tr>\n
55<\/td>\n16.1.2 Test loading conditions
16.2 Static proof test
16.2.1 Test method <\/td>\n<\/tr>\n
57<\/td>\n16.2.2 Performance requirement
16.2.3 Compliance conditions <\/td>\n<\/tr>\n
59<\/td>\n16.3 Static ultimate strength test
16.3.1 Test method <\/td>\n<\/tr>\n
62<\/td>\n16.3.2 Performance requirements
16.3.3 Compliance conditions <\/td>\n<\/tr>\n
63<\/td>\n16.4 Cyclic test
16.4.1 Test method <\/td>\n<\/tr>\n
66<\/td>\n16.4.2 Performance requirements <\/td>\n<\/tr>\n
67<\/td>\n16.4.3 Compliance conditions <\/td>\n<\/tr>\n
69<\/td>\n17 Test laboratory\/facility log
17.1 General requirements
17.2 Specific requirements
18 Test report
18.1 General requirements <\/td>\n<\/tr>\n
70<\/td>\n18.2 Specific requirements
18.3 Options
19 Classification and designation
19.1 General
19.2 Examples of classification and designation <\/td>\n<\/tr>\n
71<\/td>\n20 Labelling
20.1 General <\/td>\n<\/tr>\n
72<\/td>\n20.2 Use of mark \u201c*)\u201d and warning symbol
20.3 Examples of label layout <\/td>\n<\/tr>\n
73<\/td>\n20.4 Label placement <\/td>\n<\/tr>\n
74<\/td>\nAnnex\u00a0A (informative) Reference data for the specification of the test loading conditions and\u00a0test loading levels of this International Standard <\/td>\n<\/tr>\n
82<\/td>\nAnnex\u00a0B (informative) Guidance on the application of an alternative static ultimate strength test <\/td>\n<\/tr>\n
83<\/td>\nAnnex\u00a0C (normative) Application of an additional test loading level P6, P7, and P8 <\/td>\n<\/tr>\n
85<\/td>\nAnnex\u00a0D (informative) Summary of the records to be entered in the test laboratory\/facility log <\/td>\n<\/tr>\n
91<\/td>\nAnnex\u00a0E (informative) Information on Technical Report ISO\/TR\u00a022676[[1]] <\/td>\n<\/tr>\n
102<\/td>\nAnnex\u00a0F (informative) Reference to the essential principles of safety and performance of medical devices according to ISO\/TR\u00a016142 <\/td>\n<\/tr>\n
103<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2016<\/td>\n106<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277985,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277978","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","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\/277978","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\/277985"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277978"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277978"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277978"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}