ISO 20495:2018

Name: ISO 20495:2018 — Traditional Chinese medicine — Skin electrical resistance measurement devices
SKU: ISO 20495:2018
Price: 16200 RUB
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Traditional Chinese medicine — Skin electrical resistance measurement devices

Название (английский):

ISO 20495:2018

Traditional Chinese medicine — Skin electrical resistance measurement devices

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 20 апреля 2018 г.
Издание:: ISO IS 20495 edition 1 version 1
ICS:: 11.040.99

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Описание (английский):

ISO 20495:2018 specifies performance and test methods for skin electrical resistance measurement devices. ISO 20495:2018 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. ISO 20495:2018 is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

Abstract

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Упомянутые в описании и другие стандарты ISO

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.

Regulatory and quality assurance teams preparing technical documentation and conformity evidence.

Test laboratories performing performance verification, electrical safety and EMC testing.

Clinicians and TCM practitioners seeking devices with established accuracy, safety and biocompatibility.

Product designers integrating electrodes, force sensors and signal sources to meet device limits.

Using ISO 20495 helps ensure reliable, repeatable skin electrical resistance measurements and supports regulatory compliance and market acceptance.

Related standards

IEC 60601‑1 - Medical electrical equipment - basic safety and essential performance

IEC 60601‑1‑2 - Electromagnetic compatibility for medical devices

ISO 10993‑1 - Biological evaluation of medical devices (biocompatibility)

For device implementation and rationale, consult Annex A of ISO 20495:2018.

ISO 20495:2018

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and who uses the standard

Related standards

Технические детали

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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