CnA 의료기기 인허가 컨설팅
C
.
nA
Certification & Approval
사이트 내 전체검색
APPLICABLE STANDARDS

Harmonized, EN, IEC, ISO and so on

Print
Standard  I  harmonized
EN ISO 10535 : 2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) 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 b
CONTENT
장애인 이송용 호이스트 - 요구 사항 및 시험 방법

이 표준 규격은 EN ISO 9999:1998에 정의된 장애자 운반을 목적으로 하는 호이스트와 신체지지 기구만을 위한 요구사항과 시험방법을 규정하고 있다.
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=72059186939314693
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
CUSTOMER SUPPORT

Talking with CnA

CHAT  
FAQ
Frequently Asked Questions
view  
Q&A
Questions and Answers
ask  
REQUEST
Consultation request
Request  
Introduction
Location
Privacy policy
Service
CE marking
MFDS
Maintenance service
Translation
Training
Usability engineering
Risk management
Software validation
Clinical evaluation
PMS, PSUR and PMCF
Quality management system
Related news
Related laws
Related Data
Applicable standards
Related terms
씨엔에이
의료기기 인허가 전문
경기도 남양주시 다산중앙로 19번길 25-23 블루웨일 지식산업센터 2차 345호
Copyright ⓒ CnA Co. All rights reserved.
Top