Back

EVS-EN IEC 61010-2-101:2022+A11:2022

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2018)

General information
Valid from 01.12.2022
Base Documents
IEC 61010-2-101:2018; EN IEC 61010-2-101:2022; EN IEC 61010-2-101:2022/A11:2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.12.2022
Main + amendment
01.12.2022
Main
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 inter-connected 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.
*
*
*
PDF
22.80 € incl tax
Paper
22.80 € incl tax
Browse a standard: 2.40 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Newest version Valid from 31.12.2020
Amendment

EVS-EN ISO 11607-1:2020/A11:2022

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 01.07.2022
Amendment

EVS-EN ISO 11607-2:2020/A11:2022

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Valid from 01.07.2022
Main

EVS-EN ISO 14644-8:2022

Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
Newest version Valid from 15.07.2022