ISO 6559:2024 伝統的な中国医学 — 使い捨ての滅菌三刃針 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

Introduction

Originating in ancient China, the three-edge needle is one of major types of acupuncture needles. The three-edge needle was originally called"Feng Zhen", which literally means “sharp-edge needle”. Its clinical application for the specific indications was earliest recorded in Huangdi’s Canon of Medicine, which is the earliest writing about traditional Chinese medicine. The therapy which applies the three-edge needle is called three-edge needle therapy.

The three-edge needle has a special needle body structure like an arrow head with three sharp edges. This structure was designed in order to meet specific clinical requirements, such as bloodletting and draining abscesses mainly by the manipulation methods including shallow pricking, deep pricking, multi-point shallow pricking, pricking in and edge cutting out, and needle scratching. Of the manipulation methods, pricking in and edge cutting out (mainly for breaking the fibrous tissue) and needle scratching (leaving marks on skin) can only be practiced by the three-edge needle, which cannot be replaced by other bloodletting medical instruments such as the blood point lancet and the syringe.

It is due to the special structure of the three-edge needle that the practitioner can bleed the clinically required blood amount by controlling the depth instead of repeated pricking which induces pain in patients. This structural advantage of the three-edge needle outweighs the blood point lancet and the syringe both in clinical function, such as draining an abscess, and in obtaining a clinically required amount of blood.

Since the three-edge needle is an invasive medical instrument, it is important to use the sterile needle only once. The quality of the three-edge needle has a direct impact on the safety of patients and the quality of the therapy. Therefore, this document specifies the technical parameters of the sterile three-edge needle for single use to ensure its quality and safety.

1 Scope

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.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

Bibliography