SFS-EN ISO 10328:2016:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

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.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces and moments
5 Strength and related performance requirements and conditions of use
6 Coordinate systems and test configurations

6.1 General
6.2 Axes of coordinate systems
6.3 Reference planes
6.4 Reference points
6.5 Test force
6.6 Load line
6.7 Longitudinal axis of the foot and effective joint centres and centrelines
6.8 Reference distances

7 Test loading conditions and test loading levels

7.1 Test loading conditions
7.2 Test loading levels

8 Values of test loads, dimensions and cycles
9 Compliance

9.1 General
9.2 Selection of tests required to claim compliance with this International Standard
9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to claim compliance with this International Standard
9.4 Number of tests and test samples required to claim compliance with this International Standard
9.5 Multiple use of test samples
9.6 Testing at particular test loading levels not specified in this International Standard

10 Test samples

10.1 Selection of test samples
10.2 Types of test samples
10.3 Preparation of test samples
10.4 Identification of test samples
10.5 Alignment of test samples
10.6 Worst-case alignment position of test samples

11 Responsibility for test preparation
12 Test submission document

12.1 General requirements
12.2 Information required for test samples
12.3 Information required for tests

13 Equipment

13.1 General
13.2 Equipment for the principal tests specified in 16.2 and 16.3
13.3 Equipment for the separate static test in torsion specified in 17.1
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3
13.6 Equipment for the separate tests on knee locks specified in 17.4

14 Accuracy

14.1 General
14.2 Accuracy of equipment
14.3 Accuracy of procedure

15 Test principles

15.1 General
15.2 Static test procedure
15.3 Cyclic test procedure

16 Test procedures – Principal structural tests

16.1 Test loading requirements
16.2 Principal static test procedure
16.3 Principal cyclic test procedure

17 Test procedures — Separate structural tests

17.1 Separate static test in torsion
17.2 Separate tests on ankle-foot devices and foot units
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts
17.4 Separate tests on knee locks

18 Test laboratory/facility log

18.1 General requirements
18.2 Specific requirements

19 Test report

19.1 General requirements
19.2 Specific requirements
19.3 Options

20 Classification and designation

20.1 General
20.2 Examples of classification and designation

21 Labelling

21.1 General
21.2 Use of mark “*)” and warning symbol
21.3 Examples of label layout
21.4 Label placement

Annex A Description of internal loads and their effects (informative)
Annex B Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests (informative)
Annex C Guidance on the application of an alternative static ultimate strength test (informative)
Annex D Guidance on the application of an additional test loading levels P6, P7 and P8 (normative)
Annex E Summary of the records to be entered in the test laboratory/facility log (informative)
Annex F Background information on the loading profiles generated by test equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot units according to 17.2.5.1 (informative)
Annex G Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces and moments
5 Strength and related performance requirements and conditions of use
6 Coordinate systems and test configurations

6.1 General
6.2 Axes of coordinate systems
6.3 Reference planes
6.4 Reference points
6.5 Test force
6.6 Load line
6.7 Longitudinal axis of the foot and effective joint centres and centrelines
6.8 Reference distances

7 Test loading conditions and test loading levels

7.1 Test loading conditions
7.2 Test loading levels

8 Values of test loads, dimensions and cycles
9 Compliance

9.1 General
9.2 Selection of tests required to claim compliance with this International Standard
9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to claim compliance with this International Standard
9.4 Number of tests and test samples required to claim compliance with this International Standard
9.5 Multiple use of test samples
9.6 Testing at particular test loading levels not specified in this International Standard

10 Test samples

10.1 Selection of test samples
10.2 Types of test samples
10.3 Preparation of test samples
10.4 Identification of test samples
10.5 Alignment of test samples
10.6 Worst-case alignment position of test samples

11 Responsibility for test preparation
12 Test submission document

12.1 General requirements
12.2 Information required for test samples
12.3 Information required for tests

13 Equipment

13.1 General
13.2 Equipment for the principal tests specified in 16.2 and 16.3
13.3 Equipment for the separate static test in torsion specified in 17.1
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3
13.6 Equipment for the separate tests on knee locks specified in 17.4

14 Accuracy

14.1 General
14.2 Accuracy of equipment
14.3 Accuracy of procedure

15 Test principles

15.1 General
15.2 Static test procedure
15.3 Cyclic test procedure

16 Test procedures – Principal structural tests

16.1 Test loading requirements
16.2 Principal static test procedure
16.3 Principal cyclic test procedure

17 Test procedures — Separate structural tests

17.1 Separate static test in torsion
17.2 Separate tests on ankle-foot devices and foot units
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts
17.4 Separate tests on knee locks

18 Test laboratory/facility log

18.1 General requirements
18.2 Specific requirements

19 Test report

19.1 General requirements
19.2 Specific requirements
19.3 Options

20 Classification and designation

20.1 General
20.2 Examples of classification and designation

21 Labelling

21.1 General
21.2 Use of mark “*)” and warning symbol
21.3 Examples of label layout
21.4 Label placement

Annex A Description of internal loads and their effects (informative)
Annex B Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests (informative)
Annex C Guidance on the application of an alternative static ultimate strength test (informative)
Annex D Guidance on the application of an additional test loading levels P6, P7 and P8 (normative)
Annex E Summary of the records to be entered in the test laboratory/facility log (informative)
Annex F Background information on the loading profiles generated by test equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot units according to 17.2.5.1 (informative)
Annex G Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 (informative)

Bibliography

Tuoteryhmä(t)

11.040 Terveydenhuollon laitteet »
11.180.10 Liikkumisen apuvälineet »

Sidokset

Velvoittavat viittaukset

ISO 22523:2006 External limb prostheses and external orthoses -- Requirements and test methods
ISO 22675:2016 Prosthetics -- Testing of ankle-foot devices and foot units -- Requirements and test methods
ISO 8549-1:1989 Prosthetics and orthotics -- Vocabulary -- Part 1: General terms for external limb prostheses and external orthoses

Tekninen komitea

CEN/TC 293 Assistive products and accessibility »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

01.07.2016

Julkaisupäivä

05.07.2016

Painos

2

Sivumäärä

146

Julkaisun kieli

englanti