Mon, 16 Sep 2019 09:00 GMT
Europe, OJ C 389 published on 17 November 2017 shows the latest harmonised Standards for the Medical Device Directive (MDD). Please note that from 25 May 2020, both the Medical Device Direcetive 93/42/EC and the directive on active implantable medical devices 90/385/EC will be fully replaced by the new Medical Device Regulation (MDR).
Fri, 25 May 2012 15:01 GMT
USA FCC, Office of Engineering and Technology about Medical Area Body Network First Report and Order.
Thu, 24 May 2012 15:00 GMT
USA FCC, Office of Engineering and Technology about Medical Area Body Network (MAB).
Fri, 11 Nov 2011 12:00 GMT
Industry Canada now permits UWB medical indoor communication devices in hospitals and health facilities (CB notice 2010-14) per updated section 6.5 of RSS-220 (UWB).
Mon, 18 Apr 2011 12:00 GMT
USA, 48 million US cases of food-borne illness in 2010 push industry toward RFID-enabled food safety systems. RFID systems with temperature sensors can contribute to less tainted produce and provide the same standards-based tracing, while delivering information that could prevent as much as $35 billion/year in wasted produce (source: medicalnewstoday)
Mon, 21 Mar 2011 16:00 GMT
Saudi Arabia, medical devices are about to require compliance with SASO EN 60601-1-2 (SAU/241, EMC) and EN 60601-1-6 (SAU/242, performance)and EN 60601-2-31 (SAU/243, cardic pacemakers).
Sun, 13 Feb 2011 16:00 GMT
Saudi Arabia, medical devices are about to require compliance with SASO EN 60601-1-2 (SAU/227, design and safety) and EN 60601-1-6 (SAU/228, EMC) and EN 60601-2-31 (SAU/229, performance).
Thu, 13 Jan 2011 11:00 GMT
USA, as more hospitals and clinics plug patient monitoring equipment and other devices into traditional data networks, the closer the U.S. Food and Drug Administration (FDA) comes to regulating the networks as medical devices.
Thu, 02 Dec 2010 12:00 GMT
The basic Industry Canada labeling requirements are specified in RSS Gen Issue 3 5.2 while User Manual information for licence exempt devices is specified in 7.1.3 and digital apparatus (ICES-003) in 7.1.4
Each specific RSS may have additional requirements, like RSS-210 issue 8 A4.2 (Medical Telemetry devices), A4.3 (216-217 MHz), A9.3 (5150-5250 devices "for indoor use only".
RSS-310 Issue 3 2.2 states that Cat. II devices must bear a label with manufacturer/brand name, model and text "Canada 310". RSS-310 2.3 requires to put the statement "This Category II Radiocommunication device complies with Industry Canada Standard RSS-310" in the user manual, both in English and French). Note: This article was again updated on 11 December after the issue of new revisions of the standards mentioned in this article. Contact Teleconformity for more information.
Sat, 25 Sep 2010 10:00 GMT
Europe, Analysis on compatibility of Low Power-Active Medical Implant (LP-AMI) applications within the frequency range 2360-3400 MHz, in particular for the band 2483.5-2500MHz, with incumbent services.
Thu, 5 Aug 2010 13:00 GMT
USA, FDA recongnizes IEC standards on Medical Safety (published in July 2010).
Wed, 4 Aug 2010 17:00 GMT
FCC, Investigation of the Spectrum Requirements for Advanced Medical Technologies; Amendment of Parts 2 and 95 of the Commission's Rules to Establish the Medical Device Radio-communication Service at 401-402 and 405-406 MHz (announced on 2010/07/27).
Sat, 27 Feb 2010 19:00 GMT
Industry Canada releases RSS-243 Issue 3 (minimum requirements for medical implant communication/telemetry/data service equipment using new and emerging technologies).