ISO 20487:2019 PDF

Traditional Chinese medicine — Test method of single-use acupuncture needles for electrical stimulation

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Название (английский):

ISO 20487:2019

Traditional Chinese medicine — Test method of single-use acupuncture needles for electrical stimulation

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 14 мая 2019 г.
Издание:: ISO IS 20487 edition 1 version 1
ICS:: 11.040.25

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Срок поставки:2 раб. дн. (перевод)

Цена:150 €

Описание (английский):

This document specifies a test method for characterizing the corrosion resistance of single-use acupuncture needles intended for use in electro-acupuncture treatment. This document is applicable only to testing of acupuncture needles that conform with ISO 17218. This document does not specify pass/fail criteria. Also, it is not intended to provide safety information for real clinical practice.

Технические детали

Технический комитет: ISO/TC 249 - Traditional Chinese medicine
SKU: ISO 20487:2019

Abstract

Overview

ISO 20487:2019 specifies an in vitro test method to characterize the corrosion resistance of single‑use acupuncture needles when used for electro‑acupuncture. The standard defines a repeatable laboratory procedure using simulated body fluid (1× PBS), electrical stimulation and visual inspection to document corrosion behavior. ISO 20487 applies only to needles that conform with ISO 17218 and does not set pass/fail criteria or provide clinical safety guidance.

Key topics and technical requirements

Test principle: Immerse needles in simulated body fluid, apply pulsed electrical current from a pulse generator to another needle, and inspect for corrosion at specified times.
Test solution: 1× phosphate‑buffered saline (PBS) as the simulated body fluid.
Pulse generator: Balanced biphasic waveform, output stability ±10%, frequency ≤ 1 000 Hz. Example RMS currents in the standard: (1 ± 0.1) mA, (3 ± 0.3) mA, (5 ± 0.5) mA.
Recorder: Voltage resolution ≥ 1 mV and sampling frequency ≥ 200 kHz to measure voltage/current between electrodes.
Temperature control: Simulated body fluid maintained at (37 ± 1) °C (water bath or equivalent).
Resistor: Example 10 Ω with ±1 % tolerance (allowed range 1 Ω to 500 Ω depending on generator capacity).
Geometry and positioning: Electrode spacing and immersion depths specified (ranges given in Table 1 / Annex A; e.g., inter‑electrode distance typically in the 10–30 mm range and immersion depths provided to millimetre tolerances).
Test duration and sample size: Example electrical quantities and durations are provided; a minimum of five sets of needles per test condition is recommended.
Reporting: Test reports must include details such as test date, needle type/size, test solution, pulse generator settings, measured voltage/current, electrode geometry, equipment models, result charts and any deviations.

Practical applications

Compare across needle materials, coatings, designs or manufacturing processes used for electro‑acupuncture.

Abstract

Overview

Key topics and technical requirements

Test principle: Immerse needles in simulated body fluid, apply pulsed electrical current from a pulse generator to another needle, and inspect for corrosion at specified times.
Test solution: 1× phosphate‑buffered saline (PBS) as the simulated body fluid.
Pulse generator: Balanced biphasic waveform, output stability ±10%, frequency ≤ 1 000 Hz. Example RMS currents in the standard: (1 ± 0.1) mA, (3 ± 0.3) mA, (5 ± 0.5) mA.
Recorder: Voltage resolution ≥ 1 mV and sampling frequency ≥ 200 kHz to measure voltage/current between electrodes.
Temperature control: Simulated body fluid maintained at (37 ± 1) °C (water bath or equivalent).
Resistor: Example 10 Ω with ±1 % tolerance (allowed range 1 Ω to 500 Ω depending on generator capacity).
Geometry and positioning: Electrode spacing and immersion depths specified (ranges given in Table 1 / Annex A; e.g., inter‑electrode distance typically in the 10–30 mm range and immersion depths provided to millimetre tolerances).
Test duration and sample size: Example electrical quantities and durations are provided; a minimum of five sets of needles per test condition is recommended.
Reporting: Test reports must include details such as test date, needle type/size, test solution, pulse generator settings, measured voltage/current, electrode geometry, equipment models, result charts and any deviations.

Practical applications

Compare across needle materials, coatings, designs or manufacturing processes used for electro‑acupuncture.

ISO 20487:2019 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Practical applications

Abstract

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

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