Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

26-05-2016

Publisher

International Organization for Standardization

IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures 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 ISO 22675:2016.

WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.

ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

Committee	ISO/TC 168
DevelopmentNote	Supersedes ISO 10328-1, ISO 10328-2, ISO 10328-3, ISO 10328-4, ISO 10328-5, ISO 10328-6, ISO 10328-7 and ISO 10328-8. (09/2006) Supersedes ISO/DIS 10328. (05/2016)
DocumentType	Standard
Pages	148
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 10328:2006 ISO 10328-1:1996 ISO 10328-4:1996 ISO 10328-3:1996 ISO 10328-8:1996 ISO 10328-5:1996 ISO 10328-2:1996 ISO 10328-7:1996 ISO 10328-6:1996

Standards	Relationship
NF EN ISO 10328 : 2016	Identical
NBN EN ISO 10328 : 2016	Identical
NEN EN ISO 10328 : 2016	Identical
NS EN ISO 10328 : 2006	Identical
I.S. EN ISO 10328:2016	Identical
PN EN ISO 10328 : 2016	Identical
SN EN ISO 10328:2016	Identical
UNI EN ISO 10328 : 2007	Identical
SS-EN ISO 10328 : 2016	Identical
UNE-EN ISO 10328:2017	Identical
BS EN ISO 10328:2016	Identical
EN ISO 10328:2016	Identical
DIN EN ISO 10328:2016-12	Identical
UNI EN ISO 10328:2016	Identical
GOST R ISO 10328 : 2007	Identical

I.S. EN ISO 22523:2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
BS EN ISO 22523:2006	External limb prostheses and external orthoses. Requirements and test methods
I.S. EN ISO 22675:2016	PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016)
EN ISO 22523 : 2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
PD IEC/TR 60601-4-1:2017	Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
UNE-EN ISO 22675:2017	Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
03/317861 DC : DRAFT OCT 2003	EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
IEC TR 60601-4-1:2017	Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
DIN EN ISO 22523:2007-04	External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
ISO/TR 22676:2006	Prosthetics Testing of ankle-foot devices and foot units Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
ISO/TS 16955:2016	Prosthetics — Quantification of physical parameters of ankle foot devices and foot units
13/30251846 DC : 0	BS ISO 16955 - PROSTHETICS - QUANTIFICATION OF PHYSICAL PARAMETERS OF ANKLE FOOT DEVICES AND FOOT UNITS
ISO 22675:2016	Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
ISO 22523:2006	External limb prostheses and external orthoses — Requirements and test methods
BS EN ISO 22675:2006	Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
EN ISO 22675:2016	Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
PD ISO/TS 16955:2016	Prosthetics. Quantification of physical parameters of ankle foot devices and foot units

ISO 22523:2006	External limb prostheses and external orthoses — Requirements and test methods
ISO 15032:2000	Prostheses — Structural testing of hip units
ISO 8549-1:1989	Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 22675:2016	Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods

View more information

$407.06

Including GST where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

ISO 10328:2016

Current

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription