SR EN 61010-2-101:2017

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

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, p

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General information

Status : Withdrawn
Approval date : 7/31/2017
Withdrawal date : 9/26/2025
Number of pages : 24
ICS : 11.040.55 Diagnostic equipment,19.080 Electrical and electronic testing
Technical Committee : 24 - Measure electronic equipment

Relations with other standards:

Replaces SR EN 61010-2-101:2003
Normative reference SR EN ISO 18113-5:2012
Normative reference SR EN ISO 13857:2008
Normative reference SR EN ISO 14971:2012
Replaced by SR EN IEC 61010-2-101:2023