收藏本站   设为首页
当前位置:国外标准化动态 > 中欧 > 正文

CEN-CENELEC医疗保健标准咨询委员会(ABHS)战略规划修订至2020年

发布时间: 2017-12-27 14:55:11   审校:睿智  

按照最近出版的《医疗器械(MDR)和体外医疗器械(IVDR)法规》所示,欧洲标准化委员会(CEN)和欧洲电工标准化委员会(CENELEC)的医疗保健标准咨询委员会(ABHS)的战略规划已修订至2020年。修订后的战略显示,ABHS将力图支持CEN和CENELEC技术委

员会作出明智的决策,并为医疗行业制定适当的技术政策。

在距离2020年的剩余时间内,以下将是ABHS的工作重点:

1.   支持推进标准化工作,为病人、用户利益与安全提供更好的服务。

2.   围绕MDR和IVDR法规,积极支持行业向新阶段过渡,包括未来的标准化要求。

3.   积极鼓励欧盟官方公报(OJEU)及时引用最新的受国际认可的符合标准的医疗器械标准,这是避免医疗器械市场分散的关键措施,并鼓励其他工作支持这些目标的达成,如医疗器械BT工作组的工作。

4.   努力扩充ABHS成员,并积极鼓励所有利益攸关者群体共享知识,尤其是技术委员会(TC)、制造商、保健专业人员、主管部门、合格评定机构和欧盟委员会。

5.   随时掌握CEN 医疗保健服务专项小组(Healthcare Services Focus Group)的发展情况。

 

CEN-CENELEC Advisory Board for Healthcare Standards (ABHS) updates its Strategy to 2020

In view of the recently published Medical Devices (MDR) and In Vitro Medical Devices (IVDR) Regulations, the CEN and CENELEC Advisory Board for Healthcare Standards (ABHS) has revised its Strategy to 2020. With its updated strategy, ABHS seeks to support the

CEN and CENELEC Technical Boards in taking well-informed decisions and in shaping appropriate technical policies in the healthcare sector.

In the remaining period to 2020, the following areas will be a key focus for ABHS:

6.       Support standardization work towards advancing patient, and user-benefit & safety.

7.       Actively support the transition to the new landscape under the MDR and IVDR, including the future standardization requests.

8.       Actively encourage timely citation in the Official Journal of the European Union (OJEU) of up-to-date internationally recognized standards for medical devices providing presumption of conformity, which is essential to avoid fragmentation of the medical devices

market, as well as encourage other work to support these objectives, such as the work of the Medical Devices BT Task Group.

9.       Strive to increase ABHS’ membership and actively encourage the sharing of knowledge across all stakeholder groups, particularly Technical Committees (TCs), manufacturers, healthcare professionals, competent authorities, conformity assessment bodies and

the European Commission.

10.    Stay informed about developments made in the CEN Healthcare Services Focus Group.

 

 


来源: CEN 官网
京ICP备09001239号
网站管理:国家标准化管理委员会标准信息中心
地址:北京海淀区马甸东路9号 邮编:100088 邮箱:info@sac.gov.cn
客服热线:010-82261056 QQ号:3433774297
  • 版权所有 侵权必究
  • 主管:国家标准化管理委员会
  • 主办:国家标准化管理委员会标准信息中心
  • 运营:北京中标赛宇科技有限公司
  • 经营许可证编号 京ICP证 号
  • 盗版侵权 举报热线:400-650-6190
  • 关于我们
  • 技术团队
  • 合作伙伴
  • 法律声明
  • 知识产权