ISO 24571:2022 PDF

Name: ISO 24571:2022 — Traditional Chinese medicine — General requirements for the basic safety and essential performance of electro-acupuncture stimulators
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Traditional Chinese medicine — General requirements for the basic safety and essential performance of electro-acupuncture stimulators

Название (английский):

ISO 24571:2022

Traditional Chinese medicine — General requirements for the basic safety and essential performance of electro-acupuncture stimulators

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 7 июня 2022 г.
Издание:: ISO IS 24571 edition 1 version 1
ICS:: 11.040.60

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Описание (английский):

This document specifies general requirements for the basic safety and essential performance of electro-acupuncture (EA) stimulators. It is not applicable to acupuncture needles, transcutaneous electrical nerve stimulators or electrical nerve and muscle stimulators.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview - ISO 24571:2022 (electro-acupuncture stimulators)

ISO 24571:2022, "Traditional Chinese medicine - General requirements for the basic safety and essential performance of electro-acupuncture stimulators," sets out the general safety and performance expectations for electro-acupuncture (EA) stimulators. The standard applies specifically to electrical medical equipment that delivers low‑frequency electrical stimulation via acupuncture needles and excludes acupuncture needles alone, transcutaneous electrical nerve stimulators and conventional nerve and muscle stimulators.

Key topics and technical requirements

ISO 24571:2022 addresses the full safety/performance lifecycle for EA stimulators and references core medical electrical requirements from the IEC 60601 family. Major technical topics covered include:

Scope and definitions - clear definitions for EA, EA stimulators, leads, needle clips and applied parts.

General safety and testing - alignment with IEC 60601‑1 for basic safety and essential performance; specific testing requirements when electrodes are open- or short‑circuited (see Annex B).

Classification and protection - medical electrical (ME) classification, protection against electric shock (Type B applied parts excluded) and mode-of-operation requirements.

Identification, marking and documentation - electrical input, labeling and comprehensive instructions for use.

Electrical and mechanical hazards - protection against hazardous outputs, disconnection prevention, excessive radiation and temperature hazards; construction guidance including needle clips and leads.

Controls, accuracy and usability - requirements for output amplitude, pulse parameters, independent multi‑channel control, usability (IEC 60601‑1‑6) and alarm systems (IEC 60601‑1‑8).

Electromagnetic compatibility (EMC) - emissions and immunity testing for EA stimulators, including patient-lead considerations and special cases for acupuncture-needle connections.

Programmable systems and fault handling - guidance for Programmable Electrical Medical Systems (PEMS), hazardous situations and fault-condition management.

Informative and normative annexes - system configurations, detailed test methods, impedance testing and discussion of excessive total current per session.

Applications - who uses ISO 24571:2022

This standard is practical for:

Manufacturers and designers of EA stimulators ensuring product safety, performance and regulatory readiness.

Test laboratories and conformity assessors performing IEC/ISO‑based safety and EMC testing (refer to Annex B and Annex D).

Regulatory authorities and procurement teams evaluating medical electrical equipment for clinical use in traditional Chinese medicine (TCM).

Clinicians and facility risk managers who need to understand device safety characteristics and labeling/instructions for use.

Standards developers and technical committees working on TCM device harmonization.

Related standards

IEC 60601‑1 (General requirements for basic safety and essential performance)

IEC 60601‑1‑2 (EMC)

IEC 60601‑1‑6 (Usability)

IEC 60601‑1‑8 (Alarm systems)

ISO 20487 (referenced for EA stimulator definition)

ISO 24571:2022 is essential for ensuring that electro-acupuncture stimulators meet internationally recognized safety and essential‑performance criteria within the context of traditional Chinese medicine.

ISO 24571:2022 PDF

Abstract

Похожие стандарты

Overview - ISO 24571:2022 (electro-acupuncture stimulators)

Key topics and technical requirements

Applications - who uses ISO 24571:2022

Related standards

Технические детали

IEC 60601-2-33:2010/COR1:2012

Corrigendum 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and es…

IEC 60601-1:2005

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

ISO 20487:2019

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