ISO 20495:2018 PDF

Scope: This document specifies performance and test methods for skin electrical resistance measurement devices. This document is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. This document is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

ISO 20495:2018 Referenced Document

IEC 60601-1 Medical electrical equipment - ALL PARTS
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-20 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update

2018 ISO 20495:2018 Traditional Chinese medicine - Skin electrical resistance measurement devices