5　Requirements

5.1　　The basic dimensions of the acupuncture needle should comply with the specifications listed in Clause 4.5.

5.2　There is no uniform regulation regarding thematerial of the needle handle and body.It should be of good biocompatibility.Currently,the popularly used needle body material ismade of X5CrNil8-9,X7CrNil8-9 Austenite Stainless Steel etc are given in ISO/TS 15510:2007.

Note:When thematerial of the acupuncture needle body hasbeen altered,therewill be an additional coating(such as Lubricant)on the surface of the needle body or there will be evidence indicating that it can cause harmful side effects to the human body.In such circumstances,in accordance with ISO 10993-1:2009 for guidance on biocompatibility,it is necessary to perform biological evaluation of thematerial and the final product.The basic evaluation and testing are:

a.Cytotoxicity;

b.Sensitization;

c.Intracutaneous Reactivity;

d.Ethylene oxide sterilization residuals(ifusing EO.to sterilize).

5.3　The hardness of the needle body should comply with the specifications in Table 5.

5.4　The intensity and puncture performance of the needle tip.

5.4.1　The tip of the acupuncture needle should be round and without defects,and it should have good strength.The needle tip should not have any hooks or bends after a set amount of pressure has been applied.The puncture force should not exceed the values set forth in Table 6.

5.4.2　The tip of the acupuncture needle should be round and without defects,and it should have good puncture performance.

5.5　The acupuncture needle should be of sufficient toughness,and it should not exhibit any cracks,breaks or separation of layers after the winding test.

5.6　The needle surface should be smooth,clean and free of any defector foreignmatter produced during the metal processing course and its appearance quality and coarseness parameter(Ra value)should comply with Table 7.

5.7　The point atwhich the needle handle and body connects should be firm and sturdy,and both axial displacements should be nomore than 3 mm during the pulling test by the force values shown in Table 8.

5.8　If the needle handle ismade with winding coils,the spiral loop should be arranged symmetrically without obvious gaps.

5.9　The needle handle should not have any protuberances.

5.10　The acupuncture needle should be straight and without obvious bends or curves.

5.11　The color and luster of the surface of the needle handle should be even.If the handle ismadewith plating,it should not exhibit layering or shedding.

5.12　No visiblemicrosphere is formed on the surface of needlewhen observed with normal or corrected visual acuity if lubricant is applied to the needle body.

5.13　The needle body should have good corrosion resistance.

5.14　Sterile Acupuncture Needles should be sterilized through a confirmed sterilization procedure in order to assure that the products are sterile.

Note:For appropriate sterilizationmethods,see Annex D.The Requirementsfor validation and routine control ofa sterilization process formedical devices are provided in ISO 11135-1:2007,ISO 11137-1:2006 and ISO 17665-1:2006 should apply.