Technology solutions
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Standards
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ABS 2 REAL is well
acquainted with a number of international standards and
regulations within the fields of medical devices and Information
technology. Below is a list of some of these standards. |
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Sektor
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Standard or series of standards
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Description |
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Medical devices
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ISO 13485:2003
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specifies requirements for a quality management system where an
organisation needs to demonstrate its ability to provide medical
devices and related services that consistently meet customer
requirements and regulatory requirements applicable to medical
devices and related services |
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FDA; Recognition Number 12-66:
AIUM MUS; AMERICAN INSTITUTE OF ULTRASOUND IN MEDICINE
(AIUM) |
Medical Ultrasound Safety
regulations. (Radiology)
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FDA; Recognition Number 12-121:
IEC 61847: 1998, Ultrasonics - Surgical systems. |
Measurement and declaration of
the basic output characteristics of
Ultrasonics - Surgical systems.(Radiology) |
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FDA; Recognition Number 12-100; standard Developed by NEMA |
Standard for Real Time Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic Ultrasound Equipment |
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Information Technology |
ISO/IEC - 14443-1/2/3/4 and ISO/IEC
18092:2004,
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International standards describing the paramters for
identification cards as defined in ISO/IEC 7810 and the use of
such cards in international exchange.
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| ECMA-340 |
The Standard specifies the interface and protocol
for simple wireless communication between close coupled devices.
These Near Field Communication (NFC) devices communicate with data
rates of 106, 212, and 424 kbps. |
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IEEE 802 LAN/MAN standards and Specifications for High Rate
Wireless Personal Area Networks (WPANs) |
standards for the Ethernet family, Token
Ring, Wireless LAN, Bridging and Virtual Bridged LANs. |
| ECMA-368;
High Rate Ultra Wideband
PHY and MAC Standard |
Standard specifies the ultra
wideband (UWB) physical layer (PHY) and medium access control (MAC)
sublayer for a high-speed, short-range wireless network, utilizing
all or part of the spectrum between 3 and 10 GHz, supporting data
rates up to 480 kbps |
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OIF-SPI4-02.10
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Specifies the Optical Internetworking Forum's
recommended interface for the interconnection of Physical Layer (PHY)
devices to Link Layer devices for 10 Gb/s aggregate bandwidth
applications |
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