British Standards Institution

Source:: ISO
Committee:: CH/168 - Prosthetics and orthotics
Categories:: Information management | Vocabularies | Health care technology | Standardization. General rules | Healthcare | Medical equipment | Implants for surgery, prosthetics and orthotics

Scope

This International Standard 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. It can also be used 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 may be appropriate.

Purpose

This documents has not been updated since 2006. Since then there have been many relevant developments regarding external limb prostheses and external orthoses requiring updates regarding the requirements and test methods.

One particularly relevant development is the publication of the European Medical Device Regulation.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

09/01/2020

Proposal end date:

28/02/2020

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/TC 168/N 344 - ISO/NP 22523 “External limb prostheses and external orthoses - Requirements and test methods”

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