I.S. EN ISO 10328:2016
Current
The latest, up-to-date edition.
PROSTHETICS - STRUCTURAL TESTING OF LOWER-LIMB PROSTHESES - REQUIREMENTS AND TEST METHODS (ISO 10328:2016)
Hardcopy , PDF
English
01-01-2016
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National Foreword
European foreword
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
7 Test loading conditions and test loading levels
8 Values of test loads, dimensions and cycles
9 Compliance
10 Test samples
11 Responsibility for test preparation
12 Test submission document
13 Equipment
14 Accuracy
15 Test principles
16 Test procedures - Principal structural tests
17 Test procedures - Separate structural tests
18 Test laboratory/facility log
19 Test report
20 Classification and designation
21 Labelling
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC [OJ L 169] aimed
to be covered
Bibliography
Describes procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced by the application of a single test force.
| DocumentType |
Standard
|
| Pages |
162
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 10328:2016 | Identical |
| NBN EN ISO 10328 : 2016 | Identical |
| UNI EN ISO 10328 : 2007 | Identical |
| BS EN ISO 10328:2016 | Identical |
| UNE-EN ISO 10328:2017 | Identical |
| NF EN ISO 10328 : 2016 | Identical |
| EN ISO 10328:2016 | Identical |
| NEN EN ISO 10328 : 2016 | Identical |
| ISO 10328:2016 | Identical |
| DIN EN ISO 10328:2016-12 | Identical |
| NS EN ISO 10328 : 2006 | Identical |
| 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 |
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