ISO - DIS 22523
External limb prostheses and external orthoses — Requirements and test methods
pending
| Organization: | ISO |
| Publication Date: | 25 April 2022 |
| Status: | pending |
| Page Count: | 77 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
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.
Document History
DIS 22523
April 25, 2022
External limb prostheses and external orthoses — Requirements and test methods
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...
October 1, 2006
External limb prostheses and external orthoses Requirements and test methods
A description is not available for this item.