Hivatkozási szám

MSZ EN ISO 22675:2016

Dokumentumazonosító

164356

Cím

Protézisek. Boka-láb eszközök és lábegységek vizsgálata. Követelmények és vizsgálati módszerek (ISO 22675:2016)

Angol cím

Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods (ISO 22675:2016)

Alkalmazási terület

IMPORTANT — This International Standard is suitable 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. WARNING — This International Standard is not suitable 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. 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. 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. 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. 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. 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. 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. 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.

ICS

11.040.40 Sebészeti implantátumok, protézisek és ortézisek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-12-01

Forrás

idt ISO 22675:2016; idt EN ISO 22675:2016

Előd

MSZ EN ISO 22675:2007

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

A szabvány

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