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)

IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:

•             adaptation of changes introduced by Amendment 1 of IEC 61010-1;

•             added tolerance for stability of AC voltage test equipment to Clause 6.

This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).

This new edition has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts of the IEC 61010 series, under the general title: Safety requirements for electrical equipment for measurement, control, and laboratory use, may be found on the IEC website. The equivalent Canadian adoptions can be be found on the CSA website and within the Annex of Canadian Electrical Code, Part 1.

This Part 2-101 supplements or modifies the corresponding clauses in IEC 61010-1 so as to convert that publication into the IEC standard: Particular requirements for laboratory equipment for mixing and stirring.

Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies as far as is reasonable. Where the part states “addition”, “modification”, “replacement” or “deletion”, the relevant requirement, test specification, or note in Part 1 should be adapted accordingly