ISO质量认证 首个ISO中医药国际标准发布 《一次性使用无菌针灸针》国际标准正式出版
The ISO quality certification first ISO Chinese medicine international standards issued "disposable acupuncture needle" international standard officially published
2月3日，国际标准化组织（ISO）发布信息：由中国专家担任项目提案人制定的《一次性使用无菌针灸针》国际标准正式出版，成为国际标准化组织中医药技术委员会（暂定名）（ISO/TC249）首个发布的中医药国际标准。
In February 3rd, the international organization for Standardization (ISO) issued by the information: China experts as project proposals formulated "disposable acupuncture needle" international standard officially published, becomes the Chinese medicine technical committee of the international organization for Standardization (tentative name) (ISO/TC249) first published in Chinese Medicine International standard.
目前，世界卫生组织已确认64种针灸适应症，并推荐43种病症采用针灸治疗，全球针灸针的年使用量已突破20亿支，并以每年5%～10%左右的环比速度递增。为保证中医针灸的安全性和有效性，满足和适应针灸研究和临床发展需要， ISO/TC249制定了《一次性使用无菌针灸针》国际标准。
At present, WHO has confirmed that 64 kinds of acupuncture indications, and recommend the 43 diseases by acupuncture acupuncture needle, global annual usage has exceeded 2000000000, and increases in year 5% ~ 10% monthly rate. In order to ensure the safety and effectiveness of traditional Chinese medicine and acupuncture, meet and adapt to the research and clinical development of acupuncture and moxibustion, ISO/TC249 developed a "disposable acupuncture needle" international standard.
该标准包括针灸针的名词术语；针灸针的结构和材质要求；针灸针针尖形状要求；针体直径及长度规格；合理的针体硬度与弹性要求；针尖穿刺力的范围要求；针体与针柄的连接牢固度要求；检测针尖的强度、锐度和穿刺力的试验方法等；耐腐蚀性要求；消毒灭菌和无菌要求；针灸针产品包装、标签及储存运输；针灸针的生物相容性要求与相关医疗器械国际标准的协调等12项指标。
This standard includes terms of acupuncture needle; the structure and material of the requirements of needles; acupuncture needle tip shape requirements; needle diameter and length specifications; reasonable needle body hardness and elasticity of demand; the range of needle puncture force; firm connection request the needle body and the needle handle; detection tip sharpness and strength, the penetration test methods; corrosion resistance requirements; sterilization and aseptic requirements; acupuncture needle product packaging, labeling and storage and transportation; 12 indexes of acupuncture needle biocompatibility requirements and related medical equipment international harmonization of standards etc..
《一次性使用无菌针灸针》是我国在ISO/TC249首批重点提出的国际标准提案，历经2年多的时间，在项目负责人苏州医疗用品厂有限公司董事长曹煬，针灸针质量与安全工作组（WG3）召集人、中国中医科学院针灸研究所副所长黄龙祥，及中方团队的共同努力下，在ISO相关成员国的参与和支持下，率先完成ISO国际标准各阶段论证。
"Disposable acupuncture needle" is put forward in our country the first batch of key ISO/TC249 international standard proposal, after more than 2 years of time, person in charge of medical supplies factory in Suzhou of Cao Yang of president of limited company in the project, the acupuncture needle quality and safety working group (WG3) Convenor, Chinese Academy of traditional Chinese Medicine Acupuncture Institute Vice Director Huang Longxiang, joint efforts and China team, the ISO member states related to participate in and support, to complete the various stages of the ISO international standard argument.
2009年，在国家标准化管理委员会和国家中医药管理局共同努力下，ISO正式成立中医药技术委员会（暂定名）（ISO/TC249），中国担任秘书处。ISO目前出版各领域国际标准已超过1.95万余项，对国际贸易有着极大的促进作用。
In 2009, the National Standardization Management Committee and the State Administration of traditional Chinese medicine under the joint efforts, ISO was formally established TCM Technical Committee (tentative name) (ISO/TC249), Chinese served as secretary. ISO currently publishes international standards in all areas have more than 19500 items, the promotion of international trade.
2010年，在国家标准化管理委员会和国家中医药管理局的支持下，中国中医科学院中医临床基础医学研究所成为ISO/TC249国内技术对口单位。我国在ISO/TC249的专家和项目数量逐年递增，目前有中方注册专家89人，已立项项目12项。
In 2010, the National Standardization Management Committee and the State Administration of traditional Chinese medicine's support, China basic research in clinical medicine Academy of traditional Chinese medicine has become ISO/TC249 domestic technical counterparts. In our country, the number of ISO/TC249 experts and project is increasing year by year, at present China has 89 registered experts, item 12.
ISO质量认证 首个ISO中医药国际标准发布 《一次性使用无菌针灸针》国际标准正式出版
The ISO quality certification first ISO Chinese medicine international standards issued "disposable acupuncture needle" international standard officially published