BS ISO 20495:2018 pdf download – Traditional Chinese medicine — Skin electrical resistance measurement devices This document specifies performance and test methods for skin electrical resistancemeasurement devices. This document is applicable to skin electrical resistance measurement devices through which anelectrical signal is applied on acupuncture points of the human body or specific points of the bodysurface 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. 2Normative references The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references,only the edition cited applies.Forundated references, the latest edition of the referenced document(including any amendments) applies.ISO 10993-1,Biological evaluation of medical devices — Part 1:Evaluation and testing within a riskmanagement process IEC 60601-1,Medical electric equipment – Part 1: General requirements for basic safety andessential performance IEC 60601-1-2,Medical electric equipment — Part 1-2: General requirements for basic safety and essentialperformance —Collateral standard: Electromagnetic compatibility —Requirements and tests 3Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and lEC maintain terminological databases for use in standardization at the following addresses: ISO online browsing platform: available at http:/ / www.iso.org/obp IEC Electropedia: available at http://www.electropedia.org/ 3.1 skin electrical resistance direct current(DC) resistance value or alternating current (AC) resistance value between acupuncturepoints on the skin surface of the patient (or specific points) and a reference point of the skin surface(point on the skin in contact with auxiliary electrode) 3.2 skin electrical resistance measurement device device that can detect electrical resistance on acupuncture points or specific points of the body surfaceunder the condition of electrical signals being applied to the human body 3.3 detection electrical signal voltage signal or current signal on device or for match use applied to patient for electricalresistance detection 3.4 auxiliary electrode electrode that is fixed on specific points of the patient (e.g. hand-held or fixed on palm or forehead) forreference use, which is relatively fixed during detection 3.5 exploratory electrode electrode that directly contacts acupuncture points or specific points of the patient’s body surface,constituting a pair of electrodes with an auxiliary electrode for resistance detection 3.6 detection voltage root mean square (RMS) of maximum open-circuit voltage between the auxiliary electrode and theexploratory electrode...

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