prEN ISO 22523

SLOVENSKI STANDARD
01-julij-2022
Proteze zunanjih okončin in zunanje ortoze - Zahteve in preskusne metode
(ISO/DIS 22523:2022)
External limb prostheses and external orthoses - Requirements and test methods
(ISO/DIS 22523:2022)
Externe Gliedmaßenprothesen und externe Orthesen – Anforderungen und
Prüfverfahren (ISO/DIS 22523:2022)
Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai
(ISO/DIS 22523:2022)
Ta slovenski standard je istoveten z: prEN ISO 22523
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 22523
ISO/TC 168 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-04-25 2022-07-18
External limb prostheses and external orthoses —
Requirements and test methods
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
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Reference number
NATIONAL REGULATIONS.
ISO/DIS 22523:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

ISO/DIS 22523:2022(E)
ISO TC 168
ISO/DIS 22523:2022(E)
Date: 2022-02-18
External limb prostheses and external orthoses — Requirements
and test methods
DIS stage
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This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
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Published in Switzerland
ii
ISO/DIS 22523:2022(E)
Contents
Foreword . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 Risk management . 3
4.2 Intended performance and technical documentation . 3
4.3 Clinical evaluation . 4
4.4 Strength and related conditions of use . 4
5 Requirements for materials . 5
5.1 Flammability of materials and toxicity of combustion products. 5
5.2 Biocompatibility, contaminants and residues. 6
5.2.1 General . 6
5.2.2 Contaminants and residues . 6
5.3 Infection and microbial contamination . 6
5.4 Resistance to corrosion and degradation . 6
6 Noise and vibration . 7
7 Electromagnetic compatibility (EMC) . 7
8 Electrical safety . 7
8.1 Battery-powered prosthetic and orthotic devices . 7
8.1.1 Battery housings and connections . 7
8.1.2 Charge level indicators . 7
8.2 Circuit protection . 7
8.3 Electronic programmable systems . 8
8.4 Electrically heated blankets, pads and similar flexible heating appliances . 8
8.5 Prosthetic and orthotic devices with skin contact electrodes . 8
8.6 Prosthetic and orthotic devices with radio equipment . 8
8.6.1 General . 8
8.6.2 Frequency spectrum of radio equipment . 8
8.6.3 Operation of radio equipment by the user . 8
9 Surface temperature . 8
10 Design requirements . 9
10.1 Safety of moving parts . 9
10.2 Safety of connections . 9
11 Mechanical requirements . 9
11.1 Restrictions on use . 9
11.2 Forces in soft tissues of the human body . 9
11.3 Ergonomic principles . 10
12 Information supplied by the manufacturer . 10
12.1 General . 10
12.2 Labelling . 10
12.3 Intended use . 10
13 Packaging . 11
Annex A (informative) Guidance on methods of determining the strength of upper-limb
prosthetic devices. 12
ISO/DIS 22523:2022(E)
A.1 General .12
A.2 Principle.12
A.3 Test samples .12
A.3.1 General .12
A.3.2 Selection of test samples .12
A.3.3 Preparation of test samples .13
A.3.4 Alignment of test samples .17
A.3.5 Orientation marks on test samples .18
A.4 Number of tests and test samples required .18
A.5 Multiple use of test samples .18
A.5.1 General .18
A.5.2 Restriction .18
A.6 Test submission document .19
A.6.1 General requirements .19
A.6.2 Information required for test samples .19
A.6.3 Information required for tests .19
A.7 Accuracy .20
A.7.1 General .20
A.7.2 Accuracy of equipment .20
A.7.3 Accuracy of procedure.20
A.8 Static tests .20
A.8.1 General .20
A.8.2 Distal tensile test (Test 1) .21
A.8.3 Static downward bending test (Test 2) .21
A.8.4 Static upward bending test (Test 3) .22
A.9 Cyclic tests .23
A.9.1 General .23
A.9.2 Cyclic downward bending test (Test 4) .23
A.9.3 Cyclic upward bending test (Test 5) .24
A.10 Test report .25
A.10.1 General requirements .
...