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DEKRA Dekai Guangzhou Medical Laboratory Has Obtained CNAs Qualification to Expand the Recognition Scope of Medical Equipment

2023-10-18

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.

DEKRA Dekai Guangzhou Medical Laboratory Has Obtained CNAs Qualification to Expand the Recognition Scope of Medical Equipment 1

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