EU-China High Level Forum on Standardisation
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Time
2010-10-29 | 09:00
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Venue:
Beijing
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Address:
Capital Hotel
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Fee:
Members:
FREE |
Non Members:
FREE
The objective of the forum is to exchange information, viewpoints, experience and concerns on standardization - with a specific focus on the IEC 60601-1 and its collaterals and product specific standards - in order to develop a common understanding of how to jointly promote the use of such documents considered to be state-of-the-art for medical electrical equipment. An overview of the rationale behind the development of the third edition of the IEC 60601-1 standard will be given by experts. Emphasis will be given on the changes between the second and third editions and on the benefits of the third edition, in order to understand how to move towards an even more efficient, processed-based regulatory framework. It will also be an opportunity to bring true experience from global industries who have been involved at early stages of the formulation and implementation of this international standard and who are currently working on its enforcement in their R&D and industrial processes. Chinese authorities are currently interested in gaining a better understanding on the European approach in order to further consider alternatives such as a risk management process versus a type-testing approach, and on how to supervise and ensure compliance to the IEC 60601-1 third edition. Chinese authorities and laboratories will also be able to further discuss current challenges and their vision on a cooperative way to move together with the European Commission to take advantage of what international standards can bring to support the development of an efficient regulatory framework.
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