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External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2026)
Oznaka:prEN ISO 22523
Odbor:HZN/TU S1
Ime odbora:Zdravlje, okoliš i medicinska oprema 1
Nacrt objavljen za komentiranje:2026-03-16
Rok za komentiranje:2026-03-23
Broj komentara:0
Contact email:nacrti(at)hzn.hr
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This document specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:

06 03 to 06 15 Orthoses

06 18 to 06 24 Limb prostheses

This document 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 guidance in the design and test of custom build orthosis and prosthesis.

NOTE      The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.

Sustav komentiranja nacrta norma – Sufinancirale Europska unija i EFTA    

HZN snosi isključivu odgovornost za ovu aplikaciju. Europska unija ne odgovara za upotrebu informacija koje su u njoj sadržane.