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Standard  I  harmonized

EN ISO 22523 : 2006 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be publishe

CONTENT

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.

외용 의지와 외용 보장구 — 요구사항 및 시험방법
이 표준은 KS P ISO 9999의 다음 분류를 포함한 상하지 의지 및 보조기의 요구사항과 시험방법을 명시한다.

CONDITIONS

    invasive device
    non-invasive device

    active device

    only software (active device)
    non-active device
    unintended medical purpose

    wireless

    including software
    single-use
    sterilization
    radiation
    hazardous substances

KS STANDARD LINK

https://standard.go.kr/streamdocs/view/sd;streamdocsId=72059187029919417

STANDARD LINK (IEC, ISO, ASTM, ETC.)

HARMONIZED STANDARD LINK

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

RELATED LINK

ATTACHED FILE