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EVS-EN IEC 61010-2-101:2022

Ohutusnõuded elektrilistele mõõtmis-, juhtimis- ja laboratooriumiseadmetele. Osa 2-101: Ohutusnõuded in vitro diagnostilistele (IVD) meditsiiniseadmetele

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Kehtiv alates 01.12.2022
Alusdokumendid
IEC 61010-2-101:2018; EN IEC 61010-2-101:2022
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01.12.2022
Põhitekst
01.12.2022
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02.03.2017
Põhitekst
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.
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