IEC 61010-2-101-2015 測量、控制和實(shí)驗室用電氣設備的安全要求--第2-101部分：體外診斷(IVD)醫療設備的特殊要求 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Replace the text by the following:
This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical
purposes, including self-test IVD medical purposes.
IVD medical equipment, whether used alone or in combination, is intended by the
manufacturer to be used in vitro for the examination of specimens, including blood and tissue
samples, derived from the human body, solely or principally for the purpose of providing
information concerning one or more of the following:
• a physiological or pathological state; or
• a congenital abnormality;
• the determination of safety and compatibility with potential recipients;
• the monitoring of therapeutic measures.
Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a
home environment.
NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 as
well as within the scope of this standard, considerations have to be given to  those other part 2 standards.
1.1.2 Equipment excluded from scope
Addition:
Add the following item:
aa)  Equipment in the scope of IEC 61010-2-081 unless they are specifically intended by
their manufacturer to be used for in vitro diagnostic examination.dition 2.0 2015-01 INTERNATIONAL STANDARD NORME INTERNATIONALE GROUP SAFETY PUBLICATION PUBLICATION GROUPéE DE SéCURITé Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire – Partie 2-101: Exigences particulières pour les appareils médicaux de diagnostic in vitro (DIV)