Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
(IEC 62D/1850/CDV:2021); German and English version EN 60601-2-10:2015/prA2:2021 Class/Status:
Draft,
valid
Released: 2021 -10 Published:
2021-09 -17
VDE Art. No.: 1701674
End of objection deadline:
2021-11-17
This International Standard specifies requirements for the safety of Stimulation Devices for the stimulation of nerves and muscles, as defined in 201.3.204, for use in physical medicine, hereinafter referred to as ME DEVICES. These include Stimulation Current Devices for transcutaneous electrical stimulation of nerves (TENS) and Stimulation Current Devices for electrical stimulation of muscles (EMS). DIN EN 60601-2-10 (VDE 0750-2-10) is the adaptation to the amendment to DIN EN 60601-1: 2013 and the associated supplementary standards of the DIN EN 60601-1 series. The standard includes adaptation to DIN EN 60601-1: 2013-12, conversion from undated references to dated references and adaptation to the EMC requirements according to DIN EN 60601-1-2: 2016-05. The latest version of IEC 60601-2-10 (AMD2 ED2: 2021) is changed to adapt it to the change projects of the IEC 60601-1 series. The change includes adaptations to the normative references.
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