ISO 6559:2024 PDF

Name: ISO 6559:2024 — Traditional Chinese medicine — Sterile three-edge needle for single use
SKU: ISO 6559:2024
Price: 25 EUR
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Traditional Chinese medicine — Sterile three-edge needle for single use

Название (английский):

ISO 6559:2024

Traditional Chinese medicine — Sterile three-edge needle for single use

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 1 июля 2024 г.
Издание:: ISO IS 6559 edition 1 version 1
ICS:: 11.040.25

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Цена:135 €

Описание (английский):

This document specifies the configuration, dimensions, parameters, requirements and test methods of a sterile three-edge needle for single use. It also specifies requirements for packaging, labelling, transit and storage. This document excludes requirements for the handle of a three-edge needle, which is structurally different from the body of a three-edge needle.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 6559:2024 specifies requirements for the sterile three-edge needle for single use, a traditional Chinese medicine (TCM) acupuncture instrument. The standard covers the needle’s configuration, dimensions, material, mechanical and surface properties, sterility and biocompatibility requirements, test methods (including puncture force), and requirements for packaging, labelling, transit and storage. It explicitly excludes requirements for the handle, which differs structurally from the needle body.

Key topics and technical requirements

Geometry & dimensions

Whole length (L): 50–80 mm (±2.0 mm)
Head length (L2): 1.5–20 mm
Head widest diameter (d): 1–4.5 mm
Body diameter (D): 1–3.5 mm (±0.30 mm)

Material

Must be stainless steel conforming to ISO 15510.

Mechanical & surface properties

Head hardness: ≥ 200 HV0.2 (test per ISO 6507‑1).
Surface roughness (head): Ra ≤ 0.8 μm (test per ISO 21920‑3).
Tip sharpness evaluated by puncture force (test method in Annex A).
Corrosion resistance: no corrosion before expiry if storage conditions met (see ISO 17218:2014 Annex C).

Sterility & biocompatibility

Sterilization validation and process control per ISO 11135, ISO 11137‑1, ISO 17665 as applicable.
Biological evaluation per the ISO 10993 series (Parts 1, 4, 10, 18) and ISO/TS 10993‑19.

Appearance & quality

Tip must be sharp, burr-free; head faces smooth and triangular in section; body straight and defect-free.

Packaging & labelling

Sterile primary packaging sealed with no foreign matter; packaging materials must maintain sterility and integrity.
Requirements for primary and secondary labelling and transit/storage conditions are specified.

Applications and users

ISO 6559:2024 is intended for:

Manufacturers of acupuncture and TCM devices - to design, produce and certify single‑use three-edge needles.

Quality assurance and R&D teams - to set material, dimensional, mechanical and surface control plans.

Regulatory and compliance professionals - to support technical files and conformity assessments.

Testing laboratories - to perform hardness, roughness, puncture force and corrosion resistance tests.

Healthcare procurement and clinical practitioners - to specify safe, single‑use sterile needles for three-edge needle therapy.

ISO 6559:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 17218:2014

Sterile acupuncture needles for single use

ISO 15510:2010

Stainless steels — Chemical composition

SIST EN ISO 6507-1:2023

Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2023)

SIST EN ISO 21920-3:2022

Geometrical product specifications (GPS) - Surface texture: Profile - Part 3: Specification operators (ISO 21…

ISO 11135:2014/Amd 1:2018

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and rou…

ISO 11137-1:2006/Amd 2:2018

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and rout…

SIST EN ISO 17665:2024

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.