Introduction

The Standard applies to Sterile Acupuncture Needles for single use(refers to Filiform Needles)used by professional acupuncturists.The sterile acupuncture needles for single are sterilized before leaving the factory in order to guarantee that the product is germ-free,the healthcare professional can open the sealed package and use the needle immediately.

In order to encourage innovation,the standard will no longer enforce the combination of the needle diameter and length.However,considering the clinical usage requirements,the standard provides the specifications for the needle diameter and length.

The sharpness and puncture performance of the needle tip are of a very important clinical significance.Annex A states the guidelines and the evaluationmethods for the strength and the sharpness of the needle tip,while Annex B provides two qualitative and quantitative evaluation methods to determine the tip's puncture performance.

The qualitativemethods to evaluate the tip's puncture performance are described in Annex B.Themethods are simple,direct and practical.Itmakes them especially suitable for the routine inspection and for the crosscomparison of the acupuncture needles clinical applications.They also play a very important role in the enhancement of the quality of the acupuncture needle tip.Themethods to evaluate the puncture performance of the needle tip can be used to further evaluate the puncture and puncture performance of the acupuncture needle.Currently,themore appropriatemethod is to use the needle tip to pierce through polyurethane material; however,thismethod has not yet been implemented internationally.Considering the consistency of standards in the future,this standard provides themethods to evaluate the puncture performance of the needle tip and ranks Clause 5.4.2 as a recommendatory one.The standard does not provide the sharpness index of the piercing through polyurethanematerial by the needle tip.This index will be added to the standard when it becomes appropriate.To improve product quality,all inspection reports should include the inspection information as well as the results of the performance evaluation.

Since everymanufacturer's design,production,and sterilizationmethods are different,no regulations exist for thematerials of the acupuncture needle handle.Still,the needle body and the needle handle of acupuncture needle should have good biocompatibility.The guidance for the biological evaluation of themedical devices given in ISO 10993-1 should be applied.It is highly advised that themanufacturer adheres to the guidelines when evaluating their products in order to enhance their quality.The evaluation should include the effect of the sterilization process on the acupuncture needle.

At the same time,in order to ensure product safety and efficacy,themanufacturer should perform risk analysis and enforce risk management in addition to adhering to the requirements of local rules and regulations, the relevant background data of themedical devices and clinical practice throughout the entire duration of the product's life cycle.ISO 14971 has provided manufacturers a framework for the effective management of hazards associated with the use ofmedical devices.

In some countries,the requirements proposed here are subject to legal sanctions.Such rules and regulations should take precedence over the standards set forth in this document.