Volume 6 · Issue 6 · June 2001
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 systemsMedical
devicesSystem 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 176s acceptance of these exceptions
for medical devices.