IEC 61010-2-101:2015 RLV (Redline version)

Title

Language: EN Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Language: FR 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)

Abstract

Language: EN IEC 61010-2-101:2015 RLV contains the International Standard and its Redline version. The Redline version is available in English only. The Redline version provides you with a quick and easy way to compare all the changes between this standard and its previous edition. The Redline version is not an official IEC Standard, only the current version of the standard is to be considered the official document. IEC 61010-2-101:2015 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 function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes: - excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment; - updated Biohazard and Lot symbols in Table 1 in Clause 5; - added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5; - added requirement for gas or liquid markings and ratings to Clause 5; - added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5; - added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5; - added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5; - added requirement for OPERATOR maintenance instructions to Clause 7; - added requirements for sample zones and loading zones to Clause 7; - excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8; - added requirement for biohazard marking to Clause 13; - added requirement for interlock systems containing electric/electronic or programmable components to Clause 15; - added informative reference to Usability standard IEC 62366 to Clause 16; - replaced Clause 17 with requirements of ISO 14971 for RISK assessment. - Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.

Language(s)
Language: EN
Edition
2.0
Date of issue
23.01.2015
TC 66
ICS Codes
11.040.55, 19.080
Publication number
61010
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