SIST EN ISO 22523:2007

Name: SIST EN ISO 22523:2007 — External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
SKU: SIST EN ISO 22523:2007
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External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

Название (английский):

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 93
Дата публикации:: 1 марта 2007 г.
ICS:: 11.040.40
Технический комитет:: VAZ - Healthcare

Тип поставки:

Full version167 400 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

ruen

Срок поставки:16 раб. дн. (перевод)

Цена:167 400 ₽

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 Orthoses06 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

Стандарты, упомянутые в описании

Overview

EN ISO 22523:2006 - External limb prostheses and external orthoses - specifies requirements and test methods for externally worn prosthetic and orthotic devices. Adopted by CEN from ISO 22523:2006, the standard applies to items classified in ISO 9999 as:

06 03 – 06 15 (Orthoses)

06 18 – 06 27 (Limb prostheses)

The standard addresses design and performance aspects including strength, materials, restrictions on use, risk management, and the information to be supplied for normal conditions of use. Note: special seating is excluded as it is not classified as an orthosis in ISO 9999.

Key Topics and Requirements

EN ISO 22523:2006 sets out technical requirements and test methods covering:

Risk management and intended performance: documentation, clinical evaluation and conformity to intended use.

Mechanical strength and durability: requirements for components and assemblies; guidance and test methods (see informative and normative annexes).

Materials and safety: flammability, toxicity of combustion products, biocompatibility, contaminants, resistance to corrosion and degradation.

Infection control and sterility: provisions where applicable.

Noise, vibration and ergonomics: human factors, forces on soft tissues and restrictions on use.

Electrical safety and EMC: battery-powered devices, circuit protection, electronic programmable systems, radio equipment and EMC considerations.

Surface temperature and moving parts: safety limits and control of hazards from moving or heated elements.

Information and labelling: manufacturer-supplied instructions, packaging, sterilization instructions and intended use statements.

Normative and informative annexes: e.g., Annex A (upper-limb strength guidance), Annex B (normative mechanical test for knee joint assemblies), Annex C–E (flammability guidance, operating forces, and safety principles).

Practical Applications and Users

Manufacturers and product designers of prosthetic and orthotic components to design, test and document compliance.

Test laboratories and quality engineers performing mechanical, electrical and material safety testing.

Regulatory affairs and conformity assessors - the standard supports conformity with EU Directives (notably 93/42/EEC for medical devices and aspects of 99/5/EC for radio equipment) as referenced in Annex ZA.

Clinicians, prosthetists and orthotists for understanding device limitations, safe use and labeling requirements.

Procurement and healthcare organizations requiring standards-based specifications for assistive devices.

Related Standards

ISO 9999 - Classification of products for persons with disability (used for scope classification).

ISO/TR 16142 - Reference to essential principles of safety and performance (informative linkage in annexes).

Relevant EU Directives: 93/42/EEC (medical devices) and 99/5/EC (radio equipment).

This standard is essential for ensuring the safety, performance and regulatory compliance of external limb prostheses and external orthoses.

SIST EN ISO 22523:2007

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Practical Applications and Users

Related Standards

Технические детали

ISO 22523:2006

External limb prostheses and external orthoses — Requirements and test methods

SIST EN ISO 9999:2022

Assistive products - Classification and terminology (ISO 9999:2022)

ISO/TR 16142:2006

Medical devices — Guidance on the selection of standards in support of recognized essential principles of saf…