Mike,
For Australia, some of the standards you may wish to check include:
Safety - AS/NZS 3200.X.X suite of standards (Approval and Test
Specifications - Medical electrical equipment). These are based on the IEC
601-X-X suite of standards.
EMC - AS/NZS 2064 (equivalent to CISPR 11 and EN55011)
Best regards,
Kevin Richardson
Stanimore Pty Limited
Compliance Advice & Solutions for Technology (including Australian Agent
Services)
(Legislation/Regulations/Standards)
Ph: 02-4329-4070 (Int'l: +61-2-4329-4070)
Fax: 02-4328-5639 (Int'l: +61-2-4328-5639)
Mobile: 04-1224-1620 (Int'l: +61-4-1224-1620)
Email: k...@compuserve.com
(kevin.richard...@ieee.org - alternate email)
The material transmitted in this message or contained in attachments to this
message may contain confidential and/or privileged material and is intended
only for the addressee. Any use of or reliance upon this material by persons
or entities other than the addressee is prohibited. If you receive this in
error, please notify the sender and destroy any copies of the material
immediately.
-----Original Message-----
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Mike Cantwell
Sent: Friday, 25 January 2002 6:24 AM
To: emc-pstc (E-mail)
Subject: Medical Devices in Japan and Australia
Does anyone know:
1) Standards for medical devices in Japan and Australia?
2) Approval procedure for medical devices in Japan and Australia?
Any help/direction would be appreciated.
Thanks,
Mike Cantwell
-------------------------------------------
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.
Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/
To cancel your subscription, send mail to:
majord...@ieee.org
with the single line:
unsubscribe emc-pstc
For help, send mail to the list administrators:
Michael Garretson: pstc_ad...@garretson.org
Dave Heald davehe...@mediaone.net
For policy questions, send mail to:
Richard Nute: ri...@ieee.org
Jim Bacher: j.bac...@ieee.org
All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server.
-------------------------------------------
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.
Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/
To cancel your subscription, send mail to:
majord...@ieee.org
with the single line:
unsubscribe emc-pstc
For help, send mail to the list administrators:
Michael Garretson: pstc_ad...@garretson.org
Dave Heald davehe...@mediaone.net
For policy questions, send mail to:
Richard Nute: ri...@ieee.org
Jim Bacher: j.bac...@ieee.org
All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server.
