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我国医疗器械出口欧将面临新的环保壁垒--亲稳舆论引导监测室
2012-08-09

  近日,欧盟议会和理事会在官方公报上正式公布新的WEEE(报废电子电器设备指令2012/19/EU。该指令将于2012年8月13日生效。据了解,WEEE指令规定了电气电子设备(EEE)生命周期内涉及的所有经营者(例如生产商、经销商和消费者)的环保责任。我国医疗器械出口欧盟将面对新的环保壁垒。

recently,The European parliament and to the council official in the bulletin of the officially announced new WEEE(Discarded electronic electrical equipment)EU directive 2012/19 /。The instructions will be on August 13, 2012 effect。According to understand,The WEEE directive contains provisions for electrical and electronic equipment(EEE)Life cycle all operators involved(Such as producers、Dealers and consumers)Environmental responsibility。China's medical equipment export the eu will face new environmental barriers。

  新WEEE指令还规定了适用的电气电子设备范围。从2012年8月13日~2018年8月14日为过渡期,在这一时期内新指令适用的医疗器械包括了放射治疗设备、心血管相关的设备、透析设备、肺部通气机、核医学设备、体外诊断用实验设备、分析仪、冷冻仪、授精测试仪器以及其他用于检测、预防、监控、治疗、缓解疾病伤痛或残疾的器具等,但不包括植入型的以及可感染的产品。从2012年8月15日开始,新指令将涵盖所有外部直径大于50cm的大型医疗器械以及所有外部直径小于50cm的小型医疗器械,但不包括在使用寿命结束之前可能具有感染性、引起潜在感染的医疗器械、体外诊断医疗器械。

New WEEE directive also provides the suitable for electrical and electronic equipment range。From August 13, 2012-August 14, 2018 for the transition,In the same period the new instructions applicable medical equipment including radiation treatment equipment、Cardiovascular related equipment、Dialysis machine、Lung ventilation machine、Nuclear medical equipment、With in vitro diagnostic test equipment、analyzer、Frozen instrument、Fertilization test equipment and other used to test、prevention、monitoring、treatment、Ease pain or blemish disease instruments, etc,But do not include the type and can affect implanted the products。From August 15, 2012 began,The new command will cover all external diameter than 50 cm of large medical equipment and all external diameter less than 50 cm of small medical equipment,But not included in the service life before the end of may have infectious、Potentially infected medical apparatus and instruments、In vitro diagnostic medical equipment。

  对此,检验检疫部门提醒相关企业:一是密切关注各类绿色壁垒法案,并深入了解法案要求和内容;二是加大科研力度,研发环保型的绿色产品,掌握先进技术,提升产品的核心竞争力;三是积极开发新兴国家市场,扩大产品出口地,规避单一目的地出口带来的风险。

this,Department of inspection and quarantine remind relevant enterprise:One is the pay close attention to all kinds of green barrier bill,And in-depth understanding of law requires and content;2 it is increased research efforts,Research and development of green environmental protection product,Master advanced technology,Improve the core competitiveness of the products;Three is to actively develop emerging market countries,Expand product exports,Avoid the risks of a single destination export。



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