Conformity to Standards
Medical electrical equipment -Part 1-2: General requirements for
safety Collateral Standard" - Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-10 Medical electrical equipment -Part 2: Particular requirements for
the safety of nerve and muscle stimulators.
IEC60601-1-2
2. The electrode pad is compliance with:
EN ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In
Vitro Cytotoxicity.
EN ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity.
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