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Tel: +86-13543302450
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Shenzhen Upnmed Equipment Co.,Ltd
Factory Address:5th Floor,6th Building, Rongtaijia Industrial Park,Lisonglang Villiage,GongMing Town,Shenzhen of China 
Contact:Jane Zhang
Zip code:518106
Tel:+86-0755-29728789
Cel:+86-13543302450
Fax:+86-0755-29423789
E-mail:order@upnmed.org
Skype:janezhang6698
Website: www.upnmed.com & www.upnmed.org

Home > Quality Standards

Quality Standards

Quality Standards

ISO13485:2003 certification for medical devices ANSI/AAMIEC-53ECG cables and Lead wires

EN980:2003 Graphical symbols for use in the labeling o medical devices EN 1041:1998 Information supplied by the manufacturer with medical devices

ENISO 14971:2000+A1:2003 Risk Analysis ISO 10993-5 Biological evaluation of medical devices --Part 5:Tests for vitro cytotoxicity;

ISO 10993-10 Bioogical evaluation of medical devices--Part 10:Tests for irritation and delayed-type hypersensitivity;

EN 12470-4:200 Performance of electrical termometers for continuous measurements IEC 60601-2-34:2000 Medical electrical-Part  2-34:Particular requirements for the safety,including essential performance of invasive blood pressure monitoring equipment IEC 604-1-1988 Medical electrical equipment-Part: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 devices--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. GB/T 9001-2008  YZB(粤)0025-2013   YZB(粤)1188-2013

 

Quality Systems

UPNMED provids OEM and private labeling business worldwide. Doing business on a worldwide basis requires to fulfill international quality system standards ISO 9000.

UPNMED operates the manufacturing plants under ISO 13485:2003 system and has been certified(ISO 9001 and ISO13485)by NQA since August 2014.

 

Engineering

UPNMED’s extensive in-house testing and highly experienced team of Product Development Engineers offer our OEM customers a turn key advantage. UPNMED boasts a well-educaed and cxperienced R&D team maintain close interaction with our customer’s engineering professionals to guarantee their designs and made utilizing the best materisls, improved manufacturing efficiency, and use friendly designs. The ability to be a well-rounded supplier allows OEM customers to expect efficient turn-around on prototypes, pilot and prodction runs.

 

In-House Testing

UPNMED conducts a variety of tests on the items they design and manufacture


Electrical Testing

Insulation resistance; Resistance, Condctivity; Inductance, Capacitance, Impedance; Failure Analysis; Multi-point Continuity, Including components; Hi-Pot withstand to D.C.5kv;

Digital Storage Oscilloscope; Multi-point isolation to D.C.1kv; SpO2simulate.

 

Mechanical Testing

Flex Life Cycling; Flexibility; Durometer; Insertion/Extraction Life Cycle; Pul/Push Force; Coordinate Measurement with Video Photo Capabilities

 

Environmental Testing

Temperature Cycling; Immersion Leak; Humidity Cycling; Heat or Cold Soak; Chemical Resistances; Rohs Testing.