|
| Home > 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 remanufactured. A 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. |
|
|
|
