 |
| Purchase Information |
| Use this form to request purchase information on IEC online subscriptions. |
|
|
Document IEC 61010-2-101 is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.
You may also purchase this document alone from the IHS Standards Store.
IEC 61010-2-101 Document Information:
Title
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-101: Particular Requirements for in Vitro Diagnostic (IVD) Medical Equipment
Regles De Securite Pour Appareils Electriques De Mesurage, De Regulation Et De Laboratoire - Partie 2-101: Prescriptions Particulieres Pour Les Appareils Medicaux De Diagnostic in Vitro (DIV)
International Electrotechnical Commission
Publication Date:
Jan 1, 2002
Scope:
Replacement:
This part 2 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, it will also need to meet the requirements of those other part 2 standards.
About IHS
IHS (NYSE: IHS) is a leading global provider of critical technical information, decision-support tools and related services in a number of industries including aerospace and defense, automotive, construction, electronics, and energy. IHS serves customers ranging from large governments and multinational corporations to smaller companies and technical professionals in more than 100 countries. IHS been in business for more than 45 years and employ more than 2,300 people around the world.
