Preface

The standard ofWorld Federation of Acupuncture-Moxibustion Societies,which is put forward byWorld Federation of Acupuncture-Moxibustion Societies in accordance with the general requirements of sterile acupuncture needles for single use(refers to Filiform Needles),of clinical practice,and ofmedical devices.

The adjusted standard is based on WFAS standard 001:2011 and the recommendations from Standard committeemembers.Themain change is to delete the contents of the un-sterilized acupuncture needles(reusable acupuncture needles that a practitionermust sterilize before each use).

Details of themodifications are as follows:

1. Deleting the relevant contents of the un-sterilized acupuncture needles in the first paragraph in the “Introduction”.

2. Revising“1 Scope”,deleted the relevant contents of the un-sterilized acupuncture needles.The standard applies to the sterile acupuncture needles for single use(refers to Filiform Needles).

3. Deleting the original clause 4.2:“The varieties ofacupuncture needles include un-sterilized acupuncture needles(reusable acupuncture needles that a practitionermust sterilize before each use)and sterile acupuncture needles(acupuncture needles for single use).”

4. Revising TABLE 5“Hardness of the Needle Body”,TABLE 7“Appearance Quality and Ra Value”and TABLE 8“Pulling Force”,deleted the relevant contents of the un-sterilized acupuncture needles.

5. Revising the original clause 8.1:“Primary package:the information of Sterile Acupuncture Needle for single use should be on the label of the sterile primary package.”

6. Revising the original clause 8.2:“Secondary package:the labels should be on the secondary package of Sterile Acupuncture Needles for single use.”

7. Serial numbers of the chapterswere re-adjusted.

Annex A,Annex B and Annex C of this standard are normative.

Annex D of this standard is informative.

The drafting Units:Suzhou Medical Appliance Factory,China.

Main drafters:Cao Yang,Xu Aimin,Jiang Xinsui.

Members of the International working group:James Flowers(Australia),Wu Binjiang(Canada),Cao Yang(China),Huang Longxiang(China),Liu Baoyan(China),Tan Yuansheng(China),Denis Colin (France),Francois Dumont(France),Andreas Rinnoessel(Germany),Sergio Bangrazi(Italy),Cho Geun Sik(Korea),Liao Chunhua(Malaysia),Liu Yun(USA).

International observers:Naoto Ishizaki(Japan).