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China

TUV Rheinland (China)

Room 401, 4th Floor, Block C, Building 1, No. 139, Jinghai 3rd Road, Beijing Economic-Technological Development Area, Beijing, 100176, People's Republic of China, Beijing, China

A2LA|6386.01ISO/IEC 17025Register refreshed 2026-09-25
Certificates
1
Scope items
5
Standards
20
Locations
1

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A2LARefreshed
6386.01Active

Accredited standards

20

Our reading of the A2LA scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

IEC 60601 series

IEC 60601-1-3Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-1-6Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-1-8Name not checked yet
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-2Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-18Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-22Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-37Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-43Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-44Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-47Name not checked yet
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-52Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-54Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 60601-2-63Name not checked yet
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC

IEC 60825-1Name not checked yet
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 3 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021

IEC 62304Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

IEC 62366-1Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

IEC 80601-2-77Name not checked yet
As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 61010 series

IEC 61010-1Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

As written on the certificate · Line 4 (A2LA 6386.01)

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07

IEC 61010-2-081Name not checked yet
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

IEC 61010-2-101Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
As written on the certificate · Line 1 (A2LA 6386.01)

GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021

As written on the certificate · Line 2 (A2LA 6386.01)

YY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021

Scope as published by A2LA

5 lines
A2LA

ISO/IEC 17025

Active

6386.01

The scope document we hold says it was valid until 2026-07-31. That date has passed, so our copy may be out of date. We downloaded it from the A2LA register on 2026-03-14. Check the A2LA register for the current scope.

View scope

Accredited scope, certificate 6386.01

LineDisciplineMethodMatrixRange
1electricalGB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-1 Edition 3.1 2017-01; GB 9706.1:2020; GB 9706.222-2022; GB 9706.237-2020; GB 9706.218-2021; GB 9706.202-2021; YY/T 0664-2020; IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021; IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601-2-18:2009; EN 60601-2-18:2015; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; IEC 60601-1-6 Edition 3.2 2020-07; EN 60601-1-6:2010+A1:2015+A2:2021; IEC 62366-1:2015+A1:2020; EN 62366-1:2015+A1:2020; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.103-2020; IEC 60601-1-3:2008+A1:2013+A2:2021; EN 60601-1-3:2008+A1:2013+A2:2021Electrical equipment-
2electricalYY/T 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017+A2:2019; EN 60601-2-43:2010+A1:2018+A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; IEC 60601-2-54:2022; GB 9706.263-2020; IEC 60601-2-63:2012+A1:2017+A2:2021; EN 60601-2-63:2015+A1:2019+A2:2021; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; YY 9706.277-2023; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; IEC 60825-1:2014; EN 60825-1:2014+A11:2021; GB 4793.1:2007; IEC 61010-1:2010 (ed. 3); EN 61010-1:2010 (ed. 3); IEC 61010-2-081:2019; EN IEC 61010-2-081:2020; IEC 61010-2-101:2018; EN 61010-2-101:2017; IEC 61010-1 Ed 3.1 2017-01; GB 9706.222-2022; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; GB 9706.1:2020; IEC 60601-1:2005+A1:2012+A2:2020; EN 60601-1:2006+A1:2013+A12:2014+A2:2021--
3-ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; GB 9706.237-2020; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; GB 9706.202:2021; IEC 60601-2-2:2017+A1:2023; EN IEC 60601-2-2:2018; YY 9706.108-2021; IEC 60601-1-8:2006+A1:2012+A2:2020; EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021; GB 9706.243-2021; IEC 60601-2-43:2010+A1:2017 +A2:2019; EN 60601-2-43:2010+A1:2018 +A2:2020; GB 9706.244-2020; IEC 60601-2-44:2009+A1:2012+A2:2016; EN 60601-2-44:2009+A1:2012+A2:2016; GB 9706.254-2020; IEC 60601-2-54:2022; IEC 60601-2-54:2009+A1:2015+A2:2018; EN 60601-2-54:2009+A1:2015+A2:2019; YY 9706.247-2021; IEC 60601-2-47:2012; EN 60601-2-47:2015; IEC 60825-1:2014; EN 60825-1:2014+A11:2021--
4electricalANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1 Edition 3.2 2020-08; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-52 Edition 1.1 2015-03; IEC 61010-1 Edition 3.1 2017-01; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-8 Edition 2.2 2020-07; IEC 60601-2-43 Edition 2.2 2019-10; IEC 60601-2-44 Edition 3.2: 2016; IEC 60601-2-54 Edition 2.0 2022-09; IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-47 Edition 2.0 2012-02; IEC 80601-2-77 Edition 1.0 2019-07Medical Electrical Equipment; Medical Electrical Systems; Laboratory Medical Equipment-
5electrical
For the tests to which this accreditation applies, please refer to the laboratory’s Electrical Scope of Accreditation. Accredited Laboratory A2LA has accredited TÜV RHEINLAND (CHINA) LTD. Beijing, People’s Republic of China for technical competence in the field of Electrical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This laboratory also meets A2LA R256 - Specific Requirements - FDA ASCA Program. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 3rd day of October 2024. __ _____________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 6386.01 Valid to July 31, 2026

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