BS ISO 20495:2018 pdf download

BS ISO 20495:2018 pdf download.Traditional Chinese medicine — Skin electrical resistance measurement devices
1 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated 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 risk management process
IEC 60601-1, Medical electric equipment — Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2, Medical electric equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC 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 acupuncture points 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 surface under the condition of electrical signals being applied to the human body
4.3 Detection electrical signal
For either a detection voltage or detection current adjustable device, the error between the set value and actual value shall be no more than ±10 %. Conformity is determined by carrying out the following test. According to the technical documentation provided by the manufacturer, the output voltage value or the current value of detection electrical signal is set separately for each measuring range. The actual open circuit output voltage value of the device is detected or the actual short-circuit output current value is measured.