ISO 22523:2006 PDF

Name: ISO 22523:2006 — External limb prostheses and external orthoses — Requirements and test methods
SKU: ISO 22523:2006
Price: 25 EUR
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External limb prostheses and external orthoses — Requirements and test methods

Название (английский):

ISO 22523:2006

External limb prostheses and external orthoses — Requirements and test methods

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 82
Дата публикации:: 14 сентября 2006 г.
Издание:: ISO IS 22523 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

ISO 22523:2006 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 International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 22523:2006 - External limb prostheses and external orthoses: Requirements and test methods sets out general requirements and standardized test methods for external limb prostheses and orthoses (classified under ISO 9999: 06 03–06 15; 06 18–06 27). The standard addresses safety, performance, material characteristics and the information manufacturers must supply to support normal conditions of use for both individual components and assembled devices.

Key Topics

Scope and classifications: Applies to external limb prostheses and external orthoses (not special seating).

Risk management & intended performance: Requirements for hazard identification, risk control and technical documentation supporting intended use.

Clinical evaluation: Demonstration of suitability and clinical performance as part of conformity.

Strength & mechanical requirements: Methods and limits for mechanical strength, restrictions on use, forces in soft tissues, ergonomic principles.

Materials & safety: Flammability, toxicity of combustion products, biocompatibility, contamination, corrosion resistance and sterilization/sterility.

Electrical & EMC safety: Requirements for battery-powered devices, circuit protection, programmable electronics, radio equipment and electromagnetic compatibility.

Noise, vibration & surface temperature: Limits and test approaches to protect user comfort and safety.

Design & moving parts: Safety of moving parts, connections and actuating mechanisms (including force/moment tests).

Information & labelling: Required user and technical information, labelling, intended use and packaging.

Normative/Informative annexes: Includes guidance and test methods (e.g., strength testing for upper-limb prostheses, knee joint mechanical tests, flammability/toxicity tests, actuating-force methods, and linkage to essential safety principles).

Applications and Who Uses It

ISO 22523:2006 is used by:

Manufacturers of prosthetic and orthotic components and assemblies to design, test and document safety and performance.

Test laboratories implementing repeatable mechanical, flammability, electrical and biocompatibility tests.

Clinical engineers and prosthetists/orthotists to ensure devices meet safety and usability criteria.

Regulatory bodies and procurement teams to assess conformity with medical-device essential requirements (supports EU Directive 93/42/EEC and radio equipment Directive 99/5/EC where applicable).

R&D teams developing new limb prostheses or orthoses who need established test methods and design guidance.

Related Standards

ISO 9999 - Classification of assistive products for disabled persons.

ISO/TR 16142 - Essential principles of safety and performance of medical devices (referenced in Annex E).

EN 12523:1999 - European predecessor / harmonized standard referenced in the Introduction.

Relevant EU directives (93/42/EEC, 99/5/EC) for regulatory context.

Keywords: ISO 22523:2006, external limb prostheses, external orthoses, requirements, test methods, ISO 9999, strength testing, biocompatibility, EMC, electrical safety, sterility, risk management.

ISO 22523:2006 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications and Who Uses It

Related Standards

Технические детали

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