Quality Standards
ISO 13485:2003 certification for medical devices,
ANSI/AAMI EC-53 ECG cable and Leadwires
EN 980:2003 Graphical symbols for use in the labelling of medical devices
EN 1041:1998 Information supplied by the manufacturer with medical devices
EN ISO 14971:2000+A1:2003 Risk Analysis
ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity；
EN 12470-4:2000 Performance of electrical thermometers for continuous measurements
IEC 60601-2-34:2000 Medical electrical equipment-Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
IEC 601-1-1988 Medical electrical equipment-Part 1: General requirements for safety
ISO9919:2005(E) Medical electrical equipment--Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
BS EN 550:1994 Sterilization of medical device--Validation and routine control of ethylene oxide sterilization
IEC60601-2-30:1999 Medical electrical equipment--Part2-30:Particular requirements for safety including essential performance of automatic cycling non-invasive blood pressure monitoring equipment.
Quality Systems
MED-LINKET provides OEM and private labeling business worldwide. Doing business on a worldwide basis requires to fulfill international quality system standards ISO9000.
MED-LINKET operates the manufacturing plants under ISO13485:2003 system and has been certified (ISO 9001 and ISO13485) by TUV since Feb. 2005.
Engineering
MED-LINKET's extensive in-house testing and highly experienced team of Product Development Engineers offer our OEM customers a turn key advantage. MED-LINKET boasts a well-educated and experienced R&D team maintain close interaction with our customers' engineering professionals to guarantee their designs are made utilizing the best materials, improved manufacturing efficiencies, and user friendly designs. The ability to be a well-rounded supplier allows OEM customers to expect efficient turn-around on prototypes, pilot and production runs.
In-House Testing
MED-LINKET conducts a variety of tests on the items they design and manufacture
Electrical testing
Insulation resistance, ●Resistance, Conductivity, ●Inductance, Capacitance, Impedance, ●Failure analysis, ●Multi-point continuity, Including components, ●Hi-Pot withstand to d.c.5kv, a.c.5kv., ●Digital storage Oscilloscope, ●Multi-point isolation to d.c.1kv, ●SpO2 simulate
Mechanical testing
Flex Life cycling, ●Flexibility, ●Durometer, ●Insertion/Extraction Life cycle, ●Pull / Push Force, ●Coordinate Measurement with Video Photo Capabilities
Environmental testing
Temperature cycling, ●Immersion Leak, ●Humidity cycling, ●Heat or Cold Soak, ●Chemical Resitance
