ISO 22523-2006 PDF

Full title and description

ISO 22523:2006 — External limb prostheses and external orthoses — Requirements and test methods. This International Standard specifies performance requirements and associated test methods for external limb prostheses and external orthoses, addressing strength, materials, restrictions on use, risk and information to be supplied for components and assemblies under normal conditions of use.

Abstract

ISO 22523:2006 sets out mandatory requirements and test procedures for externally worn limb prostheses and orthoses (classifications from ISO 9999), with the objective of ensuring mechanical safety, material suitability and clear user information. It excludes special seating that is not normally body-worn.

General information

• Status: Published (under ISO review / to be revised; a Draft International Standard ISO/DIS 22523.2 is under development to update/replace it).
• Publication date: 2006-10 (Edition 1, published September/October 2006).
• Publisher: International Organization for Standardization (ISO), technical committee ISO/TC 168.
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 1 (ISO 22523:2006).
• Number of pages: 82 pages.

Scope

Specifies requirements and test methods for external limb prostheses and external orthoses, covering items classified under ISO 9999 ranges 06 03–06 15 (orthoses) and 06 18–06 27 (limb prostheses). The standard addresses mechanical strength, appropriate materials, limitations/restrictions for safe use, and the information to be provided with components and assemblies; it does not cover special seating that is not normally body-worn.

Key topics and requirements

• Definitions and classification aligned with ISO 9999 for orthoses and limb prostheses.
• Mechanical strength and structural performance requirements for components and assemblies.
• Material suitability and related testing (durability, corrosion, biocompatibility considerations where applicable).
• Restrictions on intended use, warnings and user/clinician information to reduce risk in normal conditions of use.
• Specified test methods to verify compliance with performance requirements.

Typical use and users

Manufacturers of external prosthetic and orthotic components and assemblies, clinical engineering and rehabilitation services, test laboratories performing type and conformity testing, product regulatory and procurement teams, and standards committees developing related guidance. These stakeholders use ISO 22523:2006 to set design, testing and information requirements for safe products.

Related standards

Linked classification and terminology from ISO 9999; national and regional adoptions (EN ISO 22523 / BS EN ISO 22523 and identical national editions) and a Draft International Standard (ISO/DIS 22523.2) in development to update/replace ISO 22523:2006. Relevant ISO/TC 168 deliverables and other standards on surgical implants, device general requirements and test methods may be used alongside this standard.

Keywords

ISO 22523, external limb prostheses, external orthoses, prosthesis testing, orthosis requirements, test methods, ISO 9999, prosthetics, orthotics, mechanical strength, materials, user information.

FAQ

Q: What is this standard?

A: ISO 22523:2006 is an International Standard that specifies requirements and test methods for external limb prostheses and external orthoses to ensure mechanical safety, material suitability and provision of appropriate user information.

Q: What does it cover?

A: It covers classification ranges from ISO 9999 for orthoses and limb prostheses, and sets out requirements and test procedures for strength, materials, limitations on use, risk reduction and associated information for components and assemblies; it excludes special seating not normally body-worn.

Q: Who typically uses it?

A: Product manufacturers, test laboratories, clinicians and rehabilitation services, regulatory and procurement bodies, and standards committees working with prosthetic and orthotic devices.

Q: Is it current or superseded?

A: ISO 22523:2006 remains a published International Standard, but it is listed for revision and a Draft International Standard ISO/DIS 22523.2 is under development to replace/update it; users should check the latest ISO status before relying on the standard for regulatory conformity.

Q: Is it part of a series?

A: It is part of the body of ISO work on prosthetics and orthotics managed by ISO/TC 168 and is linked by classification and terminology to ISO 9999; equivalent regional/national editions exist (EN ISO 22523 and national adoptions).

Q: What are the key keywords?

A: External limb prostheses, external orthoses, test methods, strength, materials, ISO 22523, ISO 9999, prosthetics, orthotics.