ДСТУ EN ISO 10328:2018 Протезування. Випробування конструкції протезів нижніх кінцівок. Вимоги та методи випробування (EN ISO 10328:2016, IDT; ISO 10328:2016, IDT)

ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ

Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
(   
(ДП «УкрНДНЦ»))

Наказ від 18.12.2018 № 502

EN ISO 10328:2016

Prosthetics —
Structural testing of lower-limb prostheses —
Requirements and test methods
(ISO 10328:2016)

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN ISO 10328:2018
(EN ISO 10328:2016, IDT; ISO 10328:2016, IDT)

Протезування.
Випробування конструкції протезів нижніх кінцівок.
Вимоги та методи випробування

З наданням чинності від 2019–01–01

Contents

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

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 (informative) Description of internal loads and their effects

Annex B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests

Annex C (informative) Guidance on the application of an alternative static ultimate strength test

Annex D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8

Annex E (informative) Summary of the records to be entered in the test laboratory/facility log

Annex F (informative) 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

Annex G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142

Bibliography