|Edition Number:||3||SCC Approved:||--|
|Edition Date:||2019-07-31||DOD Approved:||--|
|Price Code:||E||ANSI Approved:||2019-07-31|
This clause of Part 1 is applicable except as follows:
1.1.1 Equipment included in scope
Replace the text, except the first paragraph, with the following new text:
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
Add the following new item:
aa) equipment within the scope of IEC 61010-2-081 unless it is specifically intended by the manufacturer to be used for in vitro diagnostic examination.
1.2.1 Aspects included in scope
Add the following two new items:
bb) hazardous chemical substances.
1.2.2 Aspects excluded from scope
Add the following new item and note:
aa) the handling or manipulation outside the equipment of material under analysis.
NOTE Requirements covering these subjects are the responsibility of committees preparing relevant standards.