Recently, DEKRA Dekai Guangzhou Medical Laboratory successfully obtained the approval of China National Accreditation Commission for conformity assessment (CNAs), expanding the accreditation scope of medical equipment, including more than 80 standards such as IEC, en, BS, ISO, ANSI / AAMI, can / CSA, GB and YY.
CNAs is a member of ILAC and APLAC. The approval of the CNAs expansion fully affirmed the testing service technical ability of DEKRA Dekai Guangzhou Medical Laboratory, and improved the international mutual recognition of DEKRA Dekai Guangzhou Medical Laboratory. As an inspection, testing and certification institution with two notified bodies of EU medical directives (0344 in the Netherlands and 0124 in Germany), DEKRA Dekai can provide better and convenient services for the export trade of medical device enterprises.
CNAs accreditation scope of the laboratory
Include (but not limited to) the following medical equipment
General requirements for safety of medical electrical equipment IEC 60601-12012 a2:2020,
EN 60601-12013A12:2014,
ANSI/AAMI ES60601-1,
CAN/CSA-C22.2 NO. 60601-1:14,
Electromagnetic compatibility of medical electrical equipment
IEC 60601-1-22020,
EN 60601-1-2:2015,
BS EN 60601-1-2:2015
Availability of me equipment
IEC 60601-1-62013A2:2020,
EN 60601-1-62015,
CAN/CSA-C22.2 No. 60601-1-6A:11,
IEC 62366-12020,
EN 62366-12020,
CSA IEC 62366-1:15 (R2020),
ANSI/AAMI/IEC 62366-1: 2015A1:2020,
YY/T 1474-2016
Medical electrical equipment alarm system
IEC 60601-1-82012,
EN 60601-1-82013,
ANSI/AAMI/IEC 60601-1-82012,
CAN/CSAC22.2 No.60601-1-8-08A1:2014,
YY 0709-2009
Environmental awareness and design of medical electrical equipment
IEC 60601-1-92013A2:2020,
EN 60601-1-92013,
CAN/CSA C22.2 No. 60601-1-9:15
Physiological closed loop controller system for medical electrical equipment
IEC 60601-1-102013A2:2020,
EN 60601-1-102015,
CSA C22.2 No. 60601-1-10A:09 (R2020)
Medical electrical equipment household environment
IEC 60601-1-112020,
EN 60601-1-11:2015,
ANSI/AAMI HA60601-1-11:2015,
CSA-C22.2 No.60601-1-11:15
Medical electrical equipment emergency medical service environment
IEC 60601-1-122020,
EN 60601-1-122020,
ANSI/AAMI/IEC 60601-1-12:2016,
CSA-C22.2 No.60601-1-12:15(R2020)
nerve & muscle stimulator
IEC 60601-2-102016,
EN 60601-2-102016,
CAN/CSAC22.2 No.60601-2-102018
Endoscopic equipment
IEC 60601-2-18:2009,
EN60601-2-18:2015,
CAN/CSA-C22.2 No.60601-2-18:11
Automatic noninvasive sphygmomanometer
IEC 80601-2-30:2018,
EN IEC 80601-2-30:2019,
ANSI/AAMI/IEC 80601-2-30:2018,
CSA C22.2 No. 80601-2-30:19
Ultrasonic diagnosis and monitoring equipment
IEC 60601-2-372015,
EN 60601-2-372015,
CSA-C22.2 No. 60601-2-372019,
GB 9706.237-2020
Operating lamp and diagnostic lamp
IEC 60601-2-412013,
EN 60601-2-412011A1:2015
Multifunctional patient monitoring equipment
IEC 80601-2-49:2018,
EN IEC 80601-2-49:2019
Clinical thermometer
ISO 80601-2-562018,
EN ISO 80601-2-562020
Temperature screening equipment
IEC 80601-2-59:2017,
EN IEC 80601-2-59:2019,
CSA C22.2 No. 80601-2-59:10
Dental equipment
IEC 80601-2-60:2019,
EN IEC 80601-2-60:2020,
CSA C22.2 No. 80601-2-60:14
oxygenerator
ISO 80601-2-69:2014,
ISO 80601-2-69:2020,
EN ISO 80601-2-69:2014,
CAN/CSA-C22.2 No.80601-2-69:16
Rehabilitation robot
IEC 80601-2-78:2019,
EN IEC 80601-2-78:2020,
ANSI/AAMI/IEC 80601-2-78:2020,
CSA C22.2 No. 80601-2-78:19
Household phototherapy equipment IEC 60601-2-83:2019, en IEC 60601-2-83:2020 safety requirements for laboratory and in vitro diagnostic (IVD) equipment
IEC/EN 61010-1,
IEC/EN/CSA/UL 61010-2-010,
IEC/CSA 61010-2-051,
IEC/EN/CSA/UL 61010-2-081,
IEC/EN/CSA/UL 61010-2-101
Electromagnetic compatibility requirements for laboratory and in vitro diagnostic (IVD) equipment
IEC 61326-1:2012/EN 61326-1: 2013,
BS EN 61326-1:2013,
IEC 61326-1:2020,
IEC 61326-2-6:2012/EN 61326-2-6: 2013,
IEC 61326-2-6:2020,
BS EN 61326-2-6:2013
Why
DEKRA Dekai medical device service
Extensive testing services include electrical safety, performance, electromagnetic compatibility, wireless connection, functional safety, network security (IEC 62443-4-1 / 4-2, IEC 80001, UL 2900-2-1 and IEC / TR 60601-4-5), chemistry (RoHS / reach), etc. A wide range of certification services include Ce (MDR, IVDD and ivdr) certification (two bulletin bodies: Netherlands 0344 and Germany 0124), CB certification, Inmetro certification, NRTL certification, QMS quality system (ISO 1348, mdsap, TCP), etc. The qualification scope of MDR covers class III medical devices, and the qualification scope of ivdr covers class D in vitro diagnostic devices.
About DEKRA Dekai
DEKRA Dekai has been committed to safety for nearly 100 years. The German motor vehicle supervision Association, established in Berlin, Germany in 1925, is now a world-famous third-party professional testing and certification organization. In 2020, DEKRA Dekai's total business volume reached about 3.2 billion euros. Its business covers more than 60 countries and regions on six continents in the world, and more than 47000 employees are committed to providing independent expert services for safety on the road, at work and at home. These services include: vehicle inspection, claim settlement and expert evaluation, product testing, industrial inspection, consulting, audit, training and temporary employment. In 2025, DEKRA Dekai will celebrate its 100th anniversary. Its vision is to "become a global partner in a safe, reliable and sustainable world.