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Volume 6 · Issue 6 · June 2001


Page 34...

Medical Devices Draft Standard to Circulate for Balloting

TC 210 met in Tokyo April 9-13, 2001, at which a committee draft of ISO 13485, Quality management systems–Medical devices–System requirements for regulatory purposes, was completed by WG 1 and endorse by TC 210. ISO/CD 13485 will circulate among TC 210 P-members for balloting and comment. ISO/CD 13485 is only partially aligned with ISO 9001:2000, a development connected to the regulatory nature of the medical devices sector. Among other things, this article discusses the Tokyo meeting, the differences from ISO 9001:2000 in the CD and the reasons for TC 176’s acceptance of these exceptions for medical devices.