한국표준정보망

회원가입 로그인 비회원(주문조회) 장바구니0 이용안내

English

메뉴

한국표준정보망전체메뉴

세계 주요 표준,
빠르고 편리하게!

ENGLISH

검색 마이페이지 장바구니0

QUICK

닫기

TOP

해외표준 상세정보

관심표준 등록 : 표준업데이트 시 알림서비스

제공형태 더보기

구판

판매

IEC 61010-2-101:2015 RLV

Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- 발행일 : 2015-01-23
- 발행기관 : IEC
- 대체표준 : IEC 61010-2-101:2018
즐겨찾기 장바구니 담기

상품이 장바구니에 담겼습니다.
장바구니로 이동
- [영어]PDF(레드라인) 332,500원
- [영어]PRINT(레드라인) 332,500원
레드라인이란?

* RLV (Red-Line Version) : 구판과 최신판의 변경 사항을 빨간펜으로 표시해서 비교할 수 있게 만든 버전
* CMV (Commented version) : 표준의 개정 시 변경 부분(레드라인)에 대한 코멘트(메모)가 추가된 버전
* RLV 혹은 CMV를 구입하시면 최신판(Final version)은 별도로 구매하지 않아도 됩니다.

상세정보

분야
적용범위	IEC 61010-2-101:2015 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes: - excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment; - updated Biohazard and Lot symbols in Table 1 in Clause 5; - added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5; - added requirement for gas or liquid markings and ratings to Clause 5; - added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5; - added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5; - added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5; - added requirement for OPERATOR maintenance instructions to Clause 7; - added requirements for sample zones and loading zones to Clause 7; - excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8; - added requirement for biohazard marking to Clause 13; - added requirement for interlock systems containing electric/electronic or programmable components to Clause 15; - added informative reference to Usability standard IEC 62366 to Clause 16; - replaced Clause 17 with requirements of ISO 14971 for RISK assessment. - Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.
국제분류(ICS)코드	19.080 : 전기 및 전자 시험 및 측정기구 11.040.55 : 진단장비
페이지수	63
Edition	2.0

이력정보

No.	표준번호	표준명	발행일	상태
1	IEC 61010-2-101:2018 RLV상세보기	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment	2018-10-05	표준
2	IEC 61010-2-101:2015 RLV상세보기	Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment	2015-01-23	구판