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prEN ISO 22523

External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2026)

Draft Public enquiry
Comment end date 2026-05-05
Export comments Read draft and comment

Project stage codes

1. Decision on WI Proposal
2. Projektas
3. Viešoji apklausa
From 2026-03-06 till 2026-05-05
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.040.40 - Implants for surgery, prosthetics and orthotics

Technical Committee

TK 54 Assistive products for persons with disability

ForeignTC'S

CEN/TC 293

Number of comments

0

Comment start date

2026-03-06

Scope

This document specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 - 06 15 Orthoses 06 18 - 06 27 Limb prostheses It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This document is also applicable as a guide in the design and test of custom build orthosis and prosthesis. NOTE The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.

Relations

Pakeis
LST EN ISO 22523:2007