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Certifications

Certification

Description

FDA The United States Food & Drug Administration's Center for Devices and Radiological Health has granted full approval based on safety and performance certifications that is substantially equivalent to the original. For more information, visit wikipedia.

For your information, the U.S. FDA’s new policy is quoted below:

“These transducers are generally those that are manufactured by a party other than the original equipment manufacturer (OEM) and are intended to replace a transducer originally provided by the system manufacturer.  They can be either new transducers or original equipment transducers that have been modified or remanufacturedA new 510(k) premarket notification should be submitted for all non-OEM transducers.………………………………………………………………………………………………………………………………….”

--Draft version of Appendix A in “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers”, Issued by FDA, U.S.A.

CE0197 CE marking granted by EU, including 0197 for medical devices. Certifications of conformity with EU directives. For more information, visit wikipedia.
EN 60601-1:1990+A1+A2+A13
IEC 60601-1:1988+A1+A2
General safety requirements for medical equipment. Included are test requirements, documentation, protection from electrical hazards, protection from mechanical hazards, protection against excessive or unwanted radiation, protection against temperature, fire prevention, ingress of liquids, disinfection, biocompatibility etc. For more information, visit the IEC.
EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment, including Temperature Rise. For more information, visit the IEC.
EN 61157:1994 Declaration of Acoustic Output. For more information, visit the IEC.
ISO 10993 Declaration of Bio-compatibility. For more information, visit wikipedia.
EN ISO 13485:2003 Quality Management System for Medical Equipment. For more information, visit wikipedia.
EN ISO 9001:2000 Quality Management System. For more information, visit wikipedia.
IPX7 Protection of the equipment inside the enclosure against harmful ingress (submersion) of water. For more information, visit wikipedia.
ALARA Radiation Protection. For more information, visit wikipedia.
Shock protection Type BF Electric Shock Protection. For more information, visit this resource.
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