Name: ISO 20495:2018 — Traditional Chinese medicine — Skin electrical resistance measurement devices
SKU: ISO 20495:2018
Price: 25 EUR
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Abstract

Overview

ISO 20495:2018 specifies performance and test methods for skin electrical resistance measurement devices used in Traditional Chinese Medicine (TCM). It applies to non‑invasive devices that apply an electrical signal to acupuncture points or specific body surface points to detect skin electrical resistance. The standard defines measurable ranges, accuracy, safety and biocompatibility requirements, and test procedures. It does not cover software or medical analysis functions. Annex A provides additional guidance and rationale.

Key topics and requirements

Measurable range: devices shall measure skin electrical resistance from 100 Ω to 10 kΩ.
Measurement accuracy: measured values (Ω, V, A or relative) must be within ±10% of actual value.
Detection electrical signal: set vs actual voltage/current error must be within ±10%.
Detection voltage limit: RMS open‑circuit voltage shall not exceed 24 V.
Detection current limit: RMS short‑circuit detection current shall not exceed 0.5 mA.
Electrodes:
- Exploratory (contact) and auxiliary (reference) electrodes defined; auxiliary effective area ≥ 300 mm².
- Electrode force indication devices must indicate force within ±10%.
- Force sensing switch repeatability error for exploratory electrodes must be ≤ ±10%.
Safety and compatibility: devices must meet electrical safety and EMC requirements of IEC 60601‑1 and IEC 60601‑1‑2.
Biological evaluation: materials in contact with skin must be assessed per ISO 10993‑1 (biocompatibility evidence via testing, literature, or proven clinical use).
Testing methodology: the standard prescribes how to select test points, use non‑reactive resistors for calibration checks and calculate repeatability/error metrics.

Applications and who uses the standard

ISO 20495:2018 is practical for:

Manufacturers of TCM diagnostic/measurement devices to design and certify product performance and safety.

ISO 20495:2018 PDF

Abstract

Overview

Key topics and requirements

Applications and who uses the standard

Технические детали

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