CENELEC - EN IEC 61010-2-101
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
|Publication Date:||1 January 2022|
|ICS Code (Electrical and electronic testing):||19.080|
|ICS Code (Diagnostic equipment):||11.040.55|
Scope and object
This part of IEC 61010 provides particular safety requirements to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It is intended to be used in conjunction with the manufacturer's RISK management but not to replace it.
NOTE 1 A good design practice of an equipment starts from the beginning with a RISK management process according to ISO 14971, which provides requirement and guidance for a comprehensive RISK management process and identifies HAZARDS and risks related with the equipment.
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 2 A system, as specified by its manufacturer, is a combination of items of equipment, at least one of these is interconnected to another item. In the following text the term equipment is used for single equipment and systems.
It is possible that 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 document. In that case, the requirements of those other Part 2 standards will also apply
Exclusions from the scope
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.
Aspects included in scope
The purpose of the requirements of this document is to ensure that HAZARDS to the OPERATOR, the SERVICE PERSONNEL and the surrounding area are reduced to a tolerable level.
bb) hazardous chemical substances.
cc) any other energy sources (see Clause 201)
Aspects excluded from scope
Replace item c) with the following:
c) EMC requirements, except when related to safety (see the IEC 61326 series);
aa) the handling or manipulation outside the equipment of material under analysis.
NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant standards