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  7. ASCA-Accredited Testing Laboratories
  1. Division of Standards and Conformity Assessment

ASCA-Accredited Testing Laboratories

This page lists ASCA-accredited testing laboratories and their respective scopes of accreditation. To see the current status and historical record for each testing laboratory's scope of ASCA Accreditation, select the plus (+) button beside the ASCA ID#.

Notes:

  • Testing laboratories who wish to participate in ASCA should demonstrate that they have been accredited by an ASCA-recognized accreditation body to the currently FDA-recognized versions of the standards and test methods included in ASCA. Please check the Recognized Consensus Standards database for the currently recognized versions.
  • Some FDA-recognized consensus standards included in ASCA have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). For the standards included in ASCA, the identical U.S. adoptions to ISO and IEC standards will also be accepted.
  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.
Some table information

Filters

ASCA ID# Organization Name ASCA Category State / Country Point of Contact Current Scope of ASCA Accreditation
TL-118 DEKRA Testing and Certification (Shanghai) Ltd. Guangzhou Branch Basic safety and essential performance China Johnson Liu
johnson.liu@dekra.com
Block 5, No.3, Qiyun Road, 
Huangpu District, 
Guangzhou, Guangdong | China

ANSI/AAMI ES60601-1
ANSI AAMI HA60601-1-11
IEC 60601-1-2 
IEC 60601-1-3 
IEC 60601-1-6 
IEC 60601-1-8 
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-2 
IEC 60601-2-10 
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-34 
IEC 60601-2-36 
IEC 60601-2-37 
IEC 60601-2-43 
IEC 60601-2-44 
IEC 60601-2-45 
IEC 60601-2-47 
IEC 60601-2-52 
IEC 60601-2-54 
IEC 60601-2-57 
IEC 60601-2-62 
IEC 60601-2-63 
IEC 60601-2-65
IEC 61010-1 
IEC 80601-2-30
ISO 80601-2-55  
ISO 80601-2-56 
IEC 80601-2-59 
IEC 80601-2-60 
ISO 80601-2-61
ISO 80601-2-69
IEC 80601-2-77 
TL-10 UL JAPAN, INC. Basic safety and essential performance Japan Pamela Gwynn
Pamela.K.Gwynn@ul.com
4383-326 ASAMA-CHO, ISE-SHI MIE-KEN 516-0021, JAPAN

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-18
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-63
IEC 60601-2-65
IEC 80601-2-30
IEC 61010-1
TL-11 Eurofins Electrical & Electronic Testing NA, Inc. (Eurofins E&E) dba CertifiGroup Basic safety and essential performance North Carolina / United States Bill Bisenius
billb@CertifiGroup.com
901 Sheldon Drive, Cary, NC 27513

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-2
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-52
IEC 60601-2-65
IEC 61010-1
TL-12 UL INTERNATIONAL POLSKA SP. Z.O.O. Basic safety and essential performance Poland Pamela Gwynn
Pamela.K.Gwynn@ul.com
RÓWNOLEGŁA 4, WARSZAWA 02-235, REPUBLIC OF POLAND

ANSI/AAMI ES60601-1
IEC 60601-1-6
IEC 60601-2-52
IEC 61010-1
IEC 80601-2-60
TL-15 TÜV SÜD America, Inc. - New Brighton Basic safety and essential performance Minnesota / United States Barry Quinlan
Barry.Quinlan@tuvsud.com
141 14th St NW, New Brighton MN 55112

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-2*
IEC 60601-1-10 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-1-6 *
IEC 60601-1-8 *
IEC 60601-2-10 *
IEC 60601-2-18 *
IEC 60601-2-2 *
IEC 60601-2-31 *
IEC 61010-1 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-16 TÜV SÜD America, Inc. - Tampa Basic safety and essential performance Florida / United States Barry Quinlan
Barry.Quinlan@tuvsud.com
5610 West Sligh Ave Ste 100, Tampa, FL 33634

ANSI/AAMI ES60601-1
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 61010-1 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-17 TÜV SÜD America, Inc. - San Diego Basic safety and essential performance California / United States Barry Quinlan
Barry.Quinlan@tuvsud.com
10040 Mesa Rim Rd, San Diego, CA 92121

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-10 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-1-2 *
IEC 60601-1-6 *
IEC 60601-1-8 *
IEC 60601-2-10 *
IEC 60601-2-18 *
IEC 60601-2-19 *
IEC 60601-2-2 *
IEC 60601-2-20 *
IEC 60601-2-21 *
IEC 60601-2-22 *
IEC 60601-2-23 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-29 *
IEC 60601-2-31 *
IEC 60601-2-34 *
IEC 60601-2-36 *
IEC 60601-2-47 *
IEC 60601-2-52 *
IEC 61010-1 *
IEC 80601-2-30 *
IEC 80601-2-60 *
ISO 80601-2-12 *
ISO 80601-2-55 *
ISO 80601-2-56 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-19 TÜV SÜD Canada, Inc. Basic safety and essential performance Canada Barry Quinlan
Barry.Quinlan@tuvsud.com
11 Gordon Collins Dr, Gormley, Ontario L0H 1G0

ANSI/AAMI ES60601-1 *
IEC 60601-1-2
IEC 60601-2-2 *
IEC 60601-2-22 *
IEC 61010-1 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-20 Cook Research Incorporated Basic safety and essential performance Indiana / United States Ray Boudreaux
Ray.Boudreaux@CookMedical.com
1 Geddes Way, West Lafayette, IN 47906

ANSI/AAMI ES60601-1
IEC 60601-2-18
IEC 60601-2-2 
TL-21 F2 Labs - Maryland Basic safety and essential performance Maryland / United States Ken Littell
klittell@f2labs.com
26501 Ridge Rd., Damascus, MD 20872

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-2
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-57
IEC 60601-2-6
IEC 61010-1
IEC 80601-2-35
IEC 80601-2-59
IEC 80601-2-60
ISO 80601-2-56
ISO 80601-2-69
ISO 80601-2-74 
TL-22 F2 Labs - Ohio Basic safety and essential performance Ohio / United States Ken Littell
klittell@f2labs.com
16740 Peters Rd. Middlefield, Ohio 44062

IEC 60601-1-2
IEC 60601-2-1 Only including section(s) 201.17/202 ;
IEC 60601-2-10 Only including section(s) 201.17/202;
IEC 60601-2-11 Only including section(s) 201.17/202;
IEC 60601-2-16 Only including section(s) 201.17/202;
IEC 60601-2-18 Only including section(s) 201.17/202;
IEC 60601-2-19
IEC 60601-2-2 Only including section(s) 201.17/202 ;
IEC 60601-2-20 Only including section(s) 201.17/202 ;
IEC 60601-2-21
IEC 60601-2-22 Only including section(s) 201.17/202 ;
IEC 60601-2-23 Only including section(s) 201.17/202 ;
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28 Only including section(s) 201.17/202 ;
IEC 60601-2-29 Only including section(s) 201.17/202 ;
IEC 60601-2-31 Only including section(s) 201.17/202 ;
IEC 60601-2-33 Only including section(s) 201.17/202 ;
IEC 60601-2-34 Only including section(s) 201.17/202 ;
IEC 60601-2-36 Only including section(s) 201.17/202 ;
IEC 60601-2-37 Only including section(s) 201.17/202 ;
IEC 60601-2-43 Only including section(s) 201.17/202 ;
IEC 60601-2-44 Only including section(s) 201.17/202 ;
IEC 60601-2-45 Only including section(s) 201.17/202 ;
IEC 60601-2-47
IEC 60601-2-5 Only including section(s) 201.17/202 ;
IEC 60601-2-50 Only including section(s) 201.17/202 ;
IEC 60601-2-52 Only including section(s) 201.17/202 ;
IEC 60601-2-54 Only including section(s) 201.17/202 ;
IEC 60601-2-57 Only including section(s) 201.17/202 ;
IEC 60601-2-6 Only including section(s) 201.17/202 ;
IEC 60601-2-64 Only including section(s) 201.17/202 ;
IEC 80601-2-59 Only including section(s) 201.17/202 ;
IEC 80601-2-60 Only including section(s) 201.17/202 ;
ISO 80601-2-12 Only including section(s) 201.17/202 ;
ISO 80601-2-55 Only including section(s) 201.17/202 ;
ISO 80601-2-56 Only including section(s) 201.17/202 ;
ISO 80601-2-61 Only including section(s) 201.17/202 ;
ISO 80601-2-69 Only including section(s) 201.17/202 ;
ISO 80601-2-70 Only including section(s) 201.17/202 ;
ISO 80601-2-80 Only Section(s) 201.17/202
TL-23 ITL Product Testing Ltd. Basic safety and essential performance Israel Ilan Cohen
icohen@itlglobal.org
1 Bat Sheva Street, Lod, Israel, 7120101

ANSI/AAMI ES60601-1 *
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-2
IEC 60601-2-5
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-33
IEC 60601-2-34
IEC 60601-2-36
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-54
ISO 80601-2-56
IEC 60601-2-57
IEC 61010-1 *
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-60
IEC 80601-2-62
IEC 80601-2-64
IEC 80601-2-68
IEC 80601-2-77
ISO 80601-2-12
ISO 80601-2-61
ISO 80601-2-70
ISO 80601-2-72
ISO 80601-2-79
ISO 80601-2-80

*Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-24 UL LLC - Melville Basic safety and essential performance New York / United States Pamela Gwynn
Pamela.K.Gwynn@ul.com
1285 WALT WHITMAN ROAD, MELVILLE, NEW YORK 11747

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-1
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-16
IEC 60601-2-17
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-22
IEC 60601-2-23
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-31
IEC 60601-2-33
IEC 60601-2-36
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-6
IEC 60601-2-63
IEC 60601-2-65
IEC 60601-2-8
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-60 
TL-25 UL LLC - Mounds View Basic safety and essential performance Minnesota / United States Pamela Gwynn
Pamela.K.Gwynn@ul.com
2222 WOODALE DRIVE, SUITE 300, MOUNDS VIEW, MN 55112

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-31
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-52
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-60
ISO 80601-2-55
ISO 80601-2-61
ISO 80601-2-70
ISO 80601-2-74 
TL-26 Medical Equipment Compliance Associates, LLC Basic safety and essential performance Wisconsin / United States Alex Grob
ag@60601-1.com
140 E. Rawson Ave, Suite 301, Oak Creek, WI 53154

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-36
IEC 60601-2-47
IEC 60601-2-52
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61
TL-27 Certification Entity for Renewable Energies, S.L. Basic safety and essential performance Spain Miguel Martinez
miguel.martinez@cerecertification.com
C/ Monturiol, 15, 28906, Getafe, Madrid

ANSI/AAMI ES60601-1
IEC 60601-1-2 
IEC 61010-1
IEC 60601-1-6
IEC 60601-2-22
IEC 60601-2-57
IEC 60601-1-11
TL-28 UL LLC - Fremont Basic safety and essential performance California / United States Pamela Gwynn
Pamela.K.Gwynn@ul.com
47173 Benicia Street, Fremont, CA 94538

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-1
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-16
IEC 60601-2-17
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-2
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-37
IEC 60601-2-44
IEC 60601-2-5
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-6
IEC 60601-2-8
IEC 61010-1
IEC 80601-2-60
ISO 80601-2-61 
TL-30 Intertek Testing Services NA, Inc. - Arlington Heights Basic safety and essential performance Illinois / United States John Quigley
john.quigley@intertek.com
545 E. Algonquin Road, Arlington Heights, IL 60005

IEC 61010-1 
TL-31 Intertek Testing Services NA, Inc. - Boxborough Basic safety and essential performance Massachusetts / United States John Quigley
john.quigley@intertek.com
70 Codman Hill Road, Boxborough, MA 01719

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-10 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-1-2 *
IEC 60601-1-3 *
IEC 60601-1-6 *
IEC 60601-1-8 *
IEC 60601-2-18 *
IEC 60601-2-19 *
IEC 60601-2-2 *
IEC 60601-2-21 *
IEC 60601-2-22 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-28 *
IEC 60601-2-33 *
IEC 60601-2-34 *
IEC 60601-2-37 *
IEC 60601-2-43 *
IEC 60601-2-44 *
IEC 60601-2-45 *
IEC 60601-2-47 *
IEC 60601-2-52 *
IEC 60601-2-54 *
IEC 60601-2-57 *
IEC 60601-2-6 *
IEC 60601-2-63 *
IEC 60601-2-65 *
IEC 60601-2-8 *
IEC 61010-1 *
IEC 80601-2-30 *
IEC 80601-2-35 *
IEC 80601-2-60 *
ISO 80601-2-12 *
ISO 80601-2-55 *
ISO 80601-2-56 *
ISO 80601-2-61 *
ISO 80601-2-69 *
ISO 80601-2-70 *
ISO 80601-2-72 *
ISO 80601-2-74 *
ISO 80601-2-80 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-32 Intertek Testing Services NA, Inc. - Duluth Basic safety and essential performance Georgia / United States John Quigley
john.quigley@intertek.com
1950 Evergreen Boulevard, Suite 100, Duluth, GA 30096

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-10 *
IEC 60601-1-11 *
IEC 60601-1-2 *
IEC 60601-1-6 *
IEC 60601-1-8 *
IEC 60601-2-10 *
IEC 60601-2-18 *
IEC 60601-2-2 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-34 *
IEC 60601-2-36 *
IEC 60601-2-37 *
IEC 60601-2-5 *
IEC 60601-2-50 *
IEC 60601-2-52 *
IEC 61010-1 *
IEC 80601-2-30 *
IEC 80601-2-35 *
IEC 80601-2-60 *
ISO 80601-2-61 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-33 Intertek Testing Services NA, Inc. - Kentwood Basic safety and essential performance Michigan / United States John Quigley
john.quigley@intertek.com
4700 Broadmoor SE, Suite 200, Kentwood, MI 49512

IEC 60601-1-2
TL-34 Intertek Testing Services NA, Inc. - Lake Forest Basic safety and essential performance California / United States John Quigley
john.quigley@intertek.com
25800 Commercentre Drive, Lake Forest, CA 92630

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-10 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-1-2
IEC 60601-1-3 *
IEC 60601-1-6 *
IEC 60601-1-8 *
IEC 60601-2-10 *
IEC 60601-2-16 *
IEC 60601-2-18 *
IEC 60601-2-2 *
IEC 60601-2-22 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-34 *
IEC 60601-2-50 *
IEC 60601-2-57 *
IEC 60601-2-6 *
IEC 61010-1 *
IEC 80601-2-30 *
IEC 80601-2-60 *
ISO 80601-2-12 *
ISO 80601-2-55 *
ISO 80601-2-56 *
ISO 80601-2-61 *
ISO 80601-2-69 *
ISO 80601-2-72 *
ISO 80601-2-74 *
ISO 80601-2-79 *
ISO 80601-2-80 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-35 Intertek Testing Services NA, Inc. - Lexington Basic safety and essential performance Kentucky / United States John Quigley
john.quigley@intertek.com
731 Enterprise Drive Lexington, KY 40510

IEC 60601-1-2 
TL-36 Intertek Testing Services NA, Inc. - Menlo Park Basic safety and essential performance California / United States John Quigley
john.quigley@intertek.com
1365 Adams Court, Menlo Park, CA 94025

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-10 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-1-2 *
IEC 60601-1-6 *
IEC 60601-1-8 *
IEC 60601-2-1 *
IEC 60601-2-10 *
IEC 60601-2-18 *
IEC 60601-2-2 *
IEC 60601-2-22 *
IEC 60601-2-27 *
IEC 60601-2-37 *
IEC 60601-2-5 *
IEC 60601-2-6 *
IEC 61010-1 *
IEC 80601-2-60 *
ISO 80601-2-56 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-37 Intertek Testing Services NA, Inc. - Fridley Basic safety and essential performance Minnesota / United States John Quigley
john.quigley@intertek.com
40 51st Way NE, Suite 100, Fridley, MN 55421

ANSI/AAMI ES60601-1
IEC 60601-1-10
IEC 60601-1-11 *
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-1
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-17
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-33
IEC 60601-2-37
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-6
IEC 60601-2-63
IEC 60601-2-68
IEC 60601-2-8
IEC 61010-1
ISO 80601-2-12
ISO 80601-2-55
ISO 80601-2-61
ISO 80601-2-69

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-38 Intertek Testing Services NA, Inc. - Plano Basic safety and essential performance Texas / United States John Quigley
john.quigley@intertek.com
1809 10th Street, Suite 400, Plano, TX 75074

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-28
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-44
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-60 
TL-39 Intertek Testing Services Shanghai Basic safety and essential performance China John Quigley
john.quigley@intertek.com
Bldg. No. 86 1198 Qinzhou Road North, Shanghai, 200233, China

IEC 60601-1-11 *
IEC 60601-1-2 
IEC 60601-1-3 *
IEC 60601-1-8 *
IEC 60601-2-1 *
IEC 60601-2-10 *
IEC 60601-2-18 *
IEC 60601-2-22 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-28 *
IEC 60601-2-33 *
IEC 60601-2-37 *
IEC 60601-2-43 *
IEC 60601-2-44 *
IEC 60601-2-45 *
ANSI/AAMI ES60601-1 
ANSI/AAMI HA60601-1-11
IEC 60601-1
IEC 61010-1 
ANSI UL 61010-1
IEC 60601-2-1
IEC 60601-2-52 *
IEC 60601-2-57 *
IEC 60601-2-63 *
IEC 60601-2-65 *
IEC 60601-2-68 *
IEC 80601-2-30 *
IEC 80601-2-60 *
ISO 80601-2-56 *
ISO 80601-2-61 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-40 Intertek Japan K.K. Basic safety and essential performance Japan John Quigley
john.quigley@intertek.com
Yasuda Shibaura No.2 Bldg. 4F, 3-2-12, Kaigan, Minato-ku, Tokyo, 108-0022, Japan

ANSI/AAMI ES60601-1 *
ANSI/UL 61010-1  *
IEC 60601-1 *
IEC 60601-1-3 *
IEC 60601-1-6 *
IEC 60601-2-18 *
IEC 60601-2-28 *
IEC 60601-2-33 *
IEC 60601-2-37 *
IEC 60601-2-43 *
IEC 60601-2-44 *
IEC 60601-2-5 *
IEC 60601-2-52 *
IEC 60601-2-54 *
IEC 60601-2-63 *
IEC 61010-1 *
IEC 80601-2-60 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-41 Intertek Italia S.P.A. Basic safety and essential performance Italy John Quigley
john.quigley@intertek.com
Via Principe di Udine 114, Campoformido, Udine 33030, Italy

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-47
IEC 61010-1
IEC 80601-2-35
IEC 80601-2-60 
TL-42 Timco Engineering, Inc., an IIA Company Basic safety and essential performance Florida / United States testing@timcoengr.com
849 NW State Road 45, Newberry, FL 32699

IEC 60601-1-2 
TL-43 Nemko USA Inc. Basic safety and essential performance California / United States sdsales@nemko.com
2210 Faraday Ave, Suite 150, Carlsbad, CA 92008

ANSI/AAMI ES60601-1
IEC 60601-1-10
IEC 60601-1-11
ANSI AAMI HA60601-1-11
IEC 60601-1-12
IEC 60601-1-2 *
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-20
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-37
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-52
IEC 60601-2-57
IEC 60601-2-62
IEC 61010-1
IEC 80601-2-60
ISO 80601-2-12
ISO 80601-2-72

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-44 Eurofins Electrical and Electronic Testing NA, Inc. - Austin Basic safety and essential performance Texas / United States Sandi Mullins 
sandi.mullins@metlabs.com
13501 McCallen Pass, Austin, TX 78753

ANSI/AAMI ES60601-1 *
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-22
IEC 60601-2-23
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-52
IEC 60601-2-57
IEC 61010-1 *
IEC 80601-2-35

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-45 Eurofins Electrical and Electronic Testing NA, Inc. - Baltimore Basic safety and essential performance Maryland / United States Sandi Mullins 
sandi.mullins@metlabs.com
914 West Patapsco Avenue, Baltimore, MD 21230

ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-54
IEC 61010-1 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-46 Eurofins Electrical and Electronic Testing NA, Inc. - Union City Basic safety and essential performance California / United States Sandi Mullins 
sandi.mullins@metlabs.com
33439 Western Avenue, Union City, CA 94587

ANSI/AAMI ES60601-1 *
IEC 60601-1-2
IEC 60601-2-18
IEC 60601-2-37
IEC 61010-1 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-47 CSA America Testing & Certification LLC - Irvine Basic safety and essential performance California / United States John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11 
IEC 60601-1-12
IEC 60601-1-6 
IEC 60601-1-8 
IEC 60601-2-10 
IEC 60601-2-18 
IEC 60601-2-2 
IEC 60601-2-22 
IEC 60601-2-31 
IEC 60601-2-37 
IEC 61010-1 
ISO 80601-2-12
IEC 80601-2-35 
IEC 80601-2-60 
ISO 80601-2-55 
ISO 80601-2-61 
ISO 80601-2-72
TL-48 CSA Group Japan Ltd. Basic safety and essential performance Japan John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-28
IEC 60601-2-33
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-54
IEC 61010-1 
TL-49 CSA Group Testing & Certification Inc. - Point Claire Basic safety and essential performance Canada John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8 *
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-2
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-33
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-63
IEC 60601-2-65
IEC 60601-2-8
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-60
ISO 80601-2-56
ISO 80601-2-61 
* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-50 CSA Group Testing & Certification Inc. - Richmond Basic safety and essential performance Canada John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-50
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
ISO 80601-2-56
ISO 80601-2-61 
TL-51 CSA Group Testing & Certification Inc. - Toronto Basic safety and essential performance Canada John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 61010-1
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-1
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-16
IEC 60601-2-17
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-2
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-23
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-31
IEC 60601-2-33
IEC 60601-2-34
IEC 60601-2-36
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-62
IEC 60601-2-63
IEC 60601-2-64
IEC 60601-2-65
IEC 60601-2-68
IEC 60601-2-8
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-59
IEC 80601-2-60
ISO 80601-2-13
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61
ISO 80601-2-69
ISO 80601-2-70
ISO 80601-2-72 
TL-52 CSA Group - Korea Basic safety and essential performance South Korea John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-63
IEC 60601-2-65
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-60
ISO 80601-2-61 
TL-53 CCIC - CSA International Certification Co., Ltd. Shanghai Branch Basic safety and essential performance China John A. Sena
john.sena@csagroup.org
8501/8801 E. Pleasant Valley Road
Cleveland, Ohio 44131-5516

ANSI/AAMI ES60601-1 *
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-1
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-63
IEC 60601-2-64
IEC 60601-2-65
IEC 60601-2-68
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-60
IEC 80601-2-77
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61
ISO 80601-2-70

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-54 Element Materials Technology Dallas-Plano Basic safety and essential performance Texas / United States Renee Walker
renee.walker@element.com
3801 E. Plano Pkwy, Suite 150, Plano, TX 75074

IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-50
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-61 
TL-55 Element Materials Technology Irvine Basic safety and essential performance California / United States Renee Walker
renee.walker@element.com
41 Tesla Ave, Irvine, CA 92618

IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-50
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-61
TL-56 Element Materials Technology Portland – Evergreen, Inc Basic safety and essential performance Oregon / United States Renee Walker
renee.walker@element.com
6775 NE Evergreen Parkway, Suite 400, Portland, OR 97124

IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-50
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-61 
TL-57 Element Materials Technology Minneapolis – Brooklyn Park Basic safety and essential performance Minnesota / United States Renee Walker
renee.walker@element.com
9349 W Broadway Ave. Brooklyn Park, MN 55445

IEC 60601-1-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-50
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-61 
TL-59 Philips Medical Systems - Andover Standards and Reliability Center Basic safety and essential performance Massachusetts / United States

Leonard Kay 
leonard.kay@philips.com
3000 Minuteman Road, Suite 201, Andover, MA 01810

ANSI/AAMI ES60601-1 *
IEC 60601-1-2 *
IEC 60601-1-6
IEC 60601-1-8
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-2-18
IEC 60601-2-23 *
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-47
IEC 80601-2-30 *
ISO 80601-2-55
ISO 80601-2-56 *
ISO 80601-2-61 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-60 Intertek Testing Services Shenzhen Ltd. Guangzhou Branch Basic safety and essential performance China John Quigley
john.quigley@intertek.com
No. 7-2 Chapin Road, Science City, GETDD, Guanzhou, Guangdong Province 510663, China

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-52
IEC 60601-2-57
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-60
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61 
TL-66 Dekra Certification, Inc. Basic safety and essential performance Virginia / United States Domingo Gálvez
domingo.galvez@dekra.com
405 Glenn Dr. Suite 11&12, Sterling, VA 20164

IEC 60601-1-2 
TL-67 Element Materials Technology Seattle-Bothell 120th Basic safety and essential performance Washington / United States Renee Walker
renee.walker@element.com
19201 120th Ave. NE, Suite 104, Bothell, WA 98011

IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-47
IEC 60601-2-50
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-61 
TL-8 UL LLC - Northbrook Basic safety and essential performance Illinois / United States Pamela Gwynn
Pamela.K.Gwynn@ul.com 333
Pfingsten Rd. Northbrook, Illinois 60062

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-2
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-23
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-34
IEC 60601-2-36
IEC 60601-2-37
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-5
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-62
IEC 60601-2-63
IEC 60601-2-65
IEC 60601-2-8
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-59
IEC 80601-2-60
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61
ISO 80601-2-69 
TL-9 UL LLC - Research Triangle Park Basic safety and essential performance North Carolina / United States Pamela Gwynn
Pamela.K.Gwynn@ul.com
12 Laboratory Drive, Research Triangle Park, North Carolina 27709

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-22
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-34
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-65
IEC 60601-2-8
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-60
IEC 80601-2-77
ISO 80601-2-61
TL-64 Acertara Acoustic Laboratories, LLC Basic safety and essential performance Colorado / United States Callie Moore
cmoore@acertaralabs.com
1950 Lefthand Creek Lane,
Longmont, CO 80501

IEC 60601-2-5*
ISO 60601-2-37*

*Standards only include some clauses on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-65 Nelson Laboratories, LLC  Biocompatibility Utah / United States James Porch
ASCA@nelsonlabs.com
6280 S Redwood Road
Salt Lake City, UT 84123 

ISO 10993-5 MEM Elution Cytotoxicity
ISO 10993-12 Sample preparation for the above test methods
TL-68 UL Verification Services (Guangzhou) Co., Ltd., Song Shan
Lake Branch		 Basic safety and essential performance China Summer Xiao
summer.xiao@ul.com
Building 10, Innovation Technology Park,
Song Shan Lake Hi tech Development Zone,
Dongguan, 523808, China 

IEC 60601-1-2
TL-71 3M Company, Hardgoods Regulatory Laboratory (HRE) Basic safety and essential performance  Minnesota / United States Yuriy Litvinov
ylitvinov@mmm.com
3M Center
Building 220-6E-E04
St. Paul, MN 55144-1000

ANSI/AAMI ES60601-1
IEC 60601-1-2*
IEC/TR 60601-4-2*
IEC 61010-1
IEC 80601-2-35

*Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information."
TL-72 Retlif Testing Laboratories - New Hampshire Basic safety and essential performance  New Hampshire / United States Scott Wentworth
swentworth@retlif.com
101 New Boston Road
Goffstown, NH 03045

IEC 60601-1-2
IEC 60601-1-11 - Only including clause 12
IEC 60601-1-12 - Only including clause 11
IEC 60601-2-25 - Only including clauses 201.17 and 202
IEC 60601-2-18 - Only including clauses 201.17 and 202
IEC 60601-2-21 - Only including clauses 201.17 and 202
IEC 60601-2-20 - Only including clauses 201.17 and 202
IEC 60601-2-19 - Only including clauses 201.17 and 202
IEC 60601-2-37 - Only including clauses 201.17 and 202
IEC 60601-2-44 - Only including clauses 201.17
IEC 60601-2-47- Only including clauses 201.17 and 202
IEC 60601-2-52 - Only including clauses 201.17
IEC 60601-2-10 - Only including clauses 201.17 and 202
IEC 60601-2-65 - Only including clauses 201.17 and 202
TL-73 Retlif Testing Laboratories - New York  Basic safety and essential performance  New York / United States Robert Bernius
rbernius@retlif.com
795 Marconi Avenue
Ronkonkoma, NY 11779

IEC 60601-1-2
IEC 60601-1-11 - Only including clause 12
IEC 60601-1-12 - Only including clause 11
IEC 60601-2-25 - Only including clauses 201.17 and 202
IEC 60601-2-18 - Only including clauses 201.17 and 202
IEC 60601-2-21 - Only including clauses 201.17 and 202
IEC 60601-2-20 - Only including clauses 201.17 and 202
IEC 60601-2-19 - Only including clauses 201.17 and 202
IEC 60601-2-37 - Only including clauses 201.17 and 202
IEC 60601-2-44 - Only including clauses 201.17
IEC 60601-2-47- Only including clauses 201.17 and 202
IEC 60601-2-52 - Only including clauses 201.17
IEC 60601-2-10 - Only including clauses 201.17 and 202
IEC 60601-2-65 - Only including clauses 201.17 and 202
TL-74  Retlif Testing Laboratories - Pennsylvania Basic safety and essential performance  Pennsylvania / United States Richard Reitz
rreitz@retlif.com
3131 Detwiler Road
Harleysville, PA 19438

IEC 60601-1-2
IEC 60601-1-11 - Only including clause 12
IEC 60601-1-12 - Only including clause 11
IEC 60601-2-25 - Only including clauses 201.17 and 202
IEC 60601-2-18 - Only including clauses 201.17 and 202
IEC 60601-2-21 - Only including clauses 201.17 and 202
IEC 60601-2-20 - Only including clauses 201.17 and 202
IEC 60601-2-19 - Only including clauses 201.17 and 202
IEC 60601-2-37 - Only including clauses 201.17 and 202
IEC 60601-2-44 - Only including clauses 201.17
IEC 60601-2-47- Only including clauses 201.17 and 202
IEC 60601-2-52 - Only including clauses 201.17
IEC 60601-2-10 - Only including clauses 201.17 and 202
IEC 60601-2-65 - Only including clauses 201.17 and 202
TL-75 UL-CCIC Company Limited Guangzhou Branch Basic safety and essential performance China Pamela Gwynn
Pamela.K.Gwynn@ul.com
ELECTRONIC BUILDING, PARAGE ELECTRONIC INDUSTRIAL PARK, NO.8, NANYUN ER ROAD,
GUANGZHOU SCIENCE PARK, GUANGZHOU 510670,
PEOPLE'S REPUBLIC OF CHINA

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-10
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-47
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61
TL-76 UL-CCIC Company Limited Basic safety and essential performance China Pamela Gwynn
Pamela.K.Gwynn@ul.com
NO. 2, CHENGWAN ROAD, SUZHOU INDUSTRIAL PARK
SUZHOU, 215122,
PEOPLE'S REPUBLIC OF CHINA

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-43
IEC 60601-2-45
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 61010-1
ISO 80601-2-69
TL-77 SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch Basic safety and essential performance China Bonnie Liao
Bonnie.liao@sgs.com
No.198 Kezhu Road, Science City
Economic & Technological Development Area
Guangzhou, Guangdong 510663
China

ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-10
IEC 60601-1-11
ANSI/AAMI HA60601-1-11
IEC 60601-1-12
IEC 60601-2-2
IEC 60601-2-5
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-33
IEC 60601-2-34
IEC 60601-2-36
IEC 60601-2-37
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-63
IEC 60601-2-65
IEC 61010-1
ISO 80601-2-12
ISO 80601-2-13
IEC 80601-2-30
ISO 80601-2-55
ISO 80601-2-56
IEC 80601-2-59
IEC 80601-2-60
ISO 80601-2-61
ISO 80601-2-69
ISO 80601-2-70
ISO 80601-2-72
ISO 80601-2-74
TL-78 Centre Testing International Group Co., Ltd. - Guangdong Basic safety and essential performance China Robin Zhang
robin.zhang@cti-cert.com
Building C, Hongwei Industrial Park, Block 70, 
Bao'an District, Shenzhen, Guangdong, 518101, 
People's Republic of China

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-2-2 
IEC 60601-2-5 
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-20
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-47
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-57
IEC 61010-1 
IEC 80601-2-30 
IEC 80601-2-35 
IEC 80601-2-59 
IEC 80601-2-60 
IEC 80601-2-77 
ISO 80601-2-56
ISO 80601-2-61
TL-79 Medical Engineering & Development Institute Incorporated dba MED Institute Basic safety and essential performance Indiana / United States Colleen Tennyson
ctennyson@medinstitute.com
1330 Win Hentschel Blvd. Ste. 100, 
West Lafayette, IN 47906

IEC 60601-2-2
Only including sub clause 201.8.8.3.104 (up to 2000V, 60 Hz)
TL-80 Compatible Electronics, Inc. - Brea Basic safety and essential performance California / United States Mike Christensen
mike@compatible-electronics.com
114 Olinda Drive
Brea, CA 92823

IEC 60601-1-2* 
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-81 Compatible Electronics, Inc. - Lake Forest Basic safety and essential performance California / United States Michael Clark
michael@compatible-electronics.com
20621 Pascal Way, 
Lake Forest, CA 92630

ANSI/AAMI ES60601-1
IEC 60601-1-2*
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11*
IEC 61010-1
*Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-82 Compatible Electronics, Inc. - Newbury Park Basic safety and essential performance California / United States Ruby Hall
ruby@compatible-electronics.com
1050 Lawrence Drive, 
Newbury Park, CA 9132

IEC 60601-1-2*
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-58 North American Science Associates (NAMSA) Biocompatibility Ohio / United States Dhruti Sheth
ASCA@namsa.com
6750 Wales Rd
Northwood,OH 43619

ISO 10993-4 Complement Activation using a U.S. marketed ELISA kit
ISO 10993-4 and ASTM F756 Direct and Indirect Hemolysis
ISO 10993-5 MEM Elution Cytotoxicity
ISO 10993-23 Dermal Irritation
ISO 10993-23 Intracutaneous Reactivity Irritation
ISO 10993-10 Closed Patch Sensitization 
ISO 10993-10 and ASTM F720 Guinea Pig Maximization Sensitization
ISO 10993-11 Acute Systemic Toxicity
ISO 10993-11 and USP <151> Material-Mediated Pyrogenicity
ISO 10993-12 Sample preparation for the above test methods
TL-62 TUV Rheinland of North America, Inc. - Pleasanton Basic safety and essential performance California/United States

Richard Decker
rdecker@us.tuv.com
1279 Quarry Lane, Suite A
Pleasanton, CA 94566

ANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-1-11
ANSI AAMI 60601-2-2
IEC 60601-2-2
IEC 60601-2-5
IEC 60601-2-6
IEC 60601-2-8
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-16
IEC 60601-2-17
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-23
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-34
IEC 60601-2-36
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-62
IEC 60601-2-63
IEC 60601-2-64
IEC 60601-2-65
IEC 60601-2-68
IEC 80601-2-30
ISO 80601-2-61
TL-86 TÜV SÜD PSB Pte Ltd Basic safety and essential performance Singapore Xin Pei Kee
Xin-Pei.KEE@tuvsud.com 
15 International Business Park
TÜV SÜD @ IBP
Singapore 609937
ANSI AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-2-6
IEC 60601-2-10
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-37
IEC 60601-2-57
IEC 61010-1*
IEC 80601-2-30
ISO 80601-2-12
ISO 80601-2-55
ISO 80601-2-61
ISO 80601-2-69
ISO 80601-2-70
ISO 80601-2-72
ISO 80601-2-74
ISO 80601-2-79
ISO 80601-2-80

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-85 Washington Laboratories, Ltd. Basic safety and essential performance Maryland / United States Steven Koster
stevek@wll.com
4840 Winchester Blvd., Ste 5
Frederick, MD 21703

ANSI AAMI ES60601-1
IEC 60601-1-2
ISO 80601-2-69
IEC TR 60601-4-2
IEC60601-1-6
IEC 60601-1-8
IEC 60601-1-10
IEC 60601-1-11
ANSI AAMI HA60601-1-11
IEC 60601-1-12
IEC 61010-1
TL-91 Underwriters Laboratories Taiwan Co., Ltd. Basic safety and essential performance Taiwan

Pamela Gwynn
Pamela.K.Gwynn@ul.com
1~6/F, 260, DA-YEH ROAD, 1ST, 2ND, 4TH, 5TH, 6TH FLOOR, 35, SEC. 2, CHUNGYANG S. ROAD, PEITOU
TAIPEI CITY, 112, TAIWAN REPUBLIC OF CHINA"

ANSI AAMI ES60601-1
ANSI AAMI HA60601-1-11
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-2
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-57
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-60
ISO 80601-2-55
ISO 80601-2-56
ISO 80601-2-61
ISO 80601-2-70
ISO 80601-2-74
TL-90 SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd Basic safety and essential performance China

Sally Shi
Sally.Shi@sgs.com
No. 588 West Jindu Road, Xinqiao, Songjiang,
Shanghai, 201612, China

ANSI AAMI ES60601-1*
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-8
IEC 60601-1-10
IEC 60601-1-6
IEC 60601-1-11
ANSI AAMI HA60601-1-11
IEC 60601-1-12
IEC 60601-2-1
IEC 60601-2-2
IEC 60601-2-5
IEC 60601-2-6
IEC 60601-2-8
IEC 60601-2-10
IEC 60601-2-11
IEC 60601-2-16
IEC 60601-2-17
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-23
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-28
IEC 60601-2-29
IEC 60601-2-31
IEC 60601-2-33
IEC 60601-2-34
IEC 60601-2-35
IEC 60601-2-36
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-62
IEC 60601-2-63
IEC 60601-2-64
IEC 60601-2-65
IEC 60601-2-68
IEC /TR 60601-4-2
IEC 61010-1*
ISO 80601-2-12
ISO 80601-2-13
IEC 80601-2-30
IEC 80601-2-35
ISO 80601-2-55
ISO 80601-2-56
IEC 80601-2-59
IEC 80601-2-60
ISO 80601-2-61
ISO 80601-2-69
ISO 80601-2-70
ISO 80601-2-72
ISO 80601-2-74
IEC 80601-2-77
ISO 80601-2-79
ISO 80601-2-80

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-89 The Standard Institution of Israel Basic safety and essential performance Israel

Irina Antonov
antonovi@sii.org.il
42 Chaim Levanon Street,
Tel Aviv, 69977 ISRAEL 

ANSI AAMI ES60601-1 *
IEC 61010-1
IEC 60601-1-2 *
IEC 60601-1-3 
IEC 60601-1-6 
IEC 60601-1-8 
IEC 60601-1-10 
IEC 60601-1-11 *
ANSI AAMI HA60601-1-11
IEC 60601-1-12
IEC 60601-2-2 *
IEC 60601-2-5
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-19
IEC 60601-2-20
IEC 60601-2-21
IEC 60601-2-22
IEC 60601-2-25 *
IEC 60601-2-27
IEC 60601-2-33 *
IEC 60601-2-34
IEC 60601-2-37
IEC 60601-2-43
IEC 60601-2-44 *
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-50
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-62
IEC 60601-2-63
IEC 60601-2-65
IEC 60601-2-68
ISO 80601-2-12
ISO 80601-2-13
IEC 80601-2-30 *
IEC 80601-2-35
ISO 80601-2-55
ISO 80601-2-56
IEC 80601-2-60
ISO 80601-2-61 *
ISO 80601-2-69
ISO 80601-2-70
ISO 80601-2-72
ISO 80601-2-74
IEC 80601-2-77
ISO 80601-2-79
ISO 80601-2-80

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-92 UL LLC - Research Triangle Park EMC Lab Basic safety and essential performance North Carolina / United States

Michael Ferrer
michael.ferrer@ul.com
12 LABORATORY DRIVE
RESEARCH TRIANGLE PARK, NORTH CAROLINA 27709

IEC 60601-1-2
IEC 60601-2-2 *
IEC 60601-2-5 *
IEC 60601-2-6 *
IEC 60601-2-10 *
IEC 60601-2-16 *
IEC 60601-2-18 *
IEC 60601-2-19 *
IEC 60601-2-20 *
IEC 60601-2-21 *
IEC 60601-2-23 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-31 *
IEC 60601-2-33 *
IEC 60601-2-34 *
IEC 60601-2-36 *
IEC 60601-2-37 *
IEC 60601-2-44 *
IEC 60601-2-45 *
IEC 60601-2-47 *
IEC 60601-2-50 *
IEC 60601-2-54 *
IEC 60601-2-62 *
IEC 60601-2-63 *
IEC 60601-2-65 *
IEC 80601-2-77 *

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-88 UL LLC - Northbrook EMC Lab Basic safety and essential performance Illinois / United States

Daniel Cieplik
dan.cieplik@ul.com
333 Pfingsten Rd.
Northbrook, IL 60062

IEC 60601-1-2
IEC 60601-2-2 *
IEC 60601-2-5 *
IEC 60601-2-6 *
IEC 60601-2-10 *
IEC 60601-2-16 *
IEC 60601-2-18 *
IEC 60601-2-19 *
IEC 60601-2-20 *
IEC 60601-2-21 *
IEC 60601-2-23 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-31 *
IEC 60601-2-33 *
IEC 60601-2-34 *
IEC 60601-2-36 *
IEC 60601-2-37 *
IEC 60601-2-44 *
IEC 60601-2-45 *
IEC 60601-2-47 *
IEC 60601-2-50 *
IEC 60601-2-54 *
IEC 60601-2-62 *
IEC 60601-2-63 *
IEC 60601-2-65 *
IEC 80601-2-77 *

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-94 Hermon Laboratorties, Ltd. Basic safety and essential performance Israel George Shleimovich
george@hermonlabs.com
66 Hatachana St., POB 23
Binyamina 3055001, Israel

ANSI AAMI ES60601-1*
ANSI AAMI HA60601-1-11*
IEC 60601-1-11*
IEC 60601-1-12*
ANSI AAMI IEC 60601-1-2
IEC 60601-1-2
IEC 60601-1-3*
IEC 60601-1-6*
IEC 60601-1-8*
ANSI AAMI IEC 60601-1-8*
ANSI UL 61010-1
IEC 60601-2-2*
IEC 60601-2-5*
IEC 60601-2-22*
IEC 60601-2-25*
IEC 60601-2-27*
IEC 60601-2-34*
IEC 60601-2-37*
IEC 60601-2-47*
IEC 60601-2-57*
IEC 60601-2-62*
IEC 61010-1*
IEC 80601-2-60*
ISO 80601-2-61*
ISO 80601-2-74*
IEC 80601-2-77

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-96 Eurofins E&E Taiwan Co., Ltd. Basic safety and essential performance Taiwan Koen Ke
KoenKe@eurofins.com
18F. No.716, Zhongzheng Rd., Zhonghe Dist.
New Taipei City 235, Taiwan (R.O.C.)

ANSI AAMI ES60601-1
IEC 60601-1-6
IEC 60601-1-8
ANSI/AAMI HA 60601-1-11
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-2
IEC 60601-2-5
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-37
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-57
IEC 60601-2-62
IEC 61010-1
IEC 80601-2-30
ISO 80601-2-56
IEC 80601-2-60
ISO 80601-2-61
TL-97 TÜV Rheinland (China) Ltd. Basic safety and essential performance China Jingming Zhao
Jingming.zhao@tuv.com
Room 401, 4F,Block C, Building 1, No.139
JingHai 3rd Road, Economic Technological Development Area
Beijing 100176, P.R. China

ANSI AAMI ES60601- 1*
IEC 60601-1-6
IEC 60601-2-2*
IEC 60601-2-18*
IEC 60601-2-22*
IEC 60601-2-37*
IEC 60601-2-52*
IEC 61010-1*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-98 MEQUIPE S.r.l. Basic safety and essential performance Italy Alessandro Melzi
alessandro.melzi@mequipe.it
Via XXV Aprile, 11-20097
San Donato Milanese, ITALY

ANSI/AAMI ES60601-1 *
IEC 60601-1-6 
IEC 60601-1-8 
IEC 60601-1-10 
IEC 60601-1-11*
IEC 60601-1-12*
IEC 60601-2-2*
IEC 60601-2-5* 
IEC 60601-2-6 
IEC 60601-2-10
IEC 60601-2-16* 
IEC 60601-2-18  
IEC 60601-2-19  
IEC 60601-2-20 
IEC 60601-2-21  
IEC 60601-2-22 
IEC 60601-2-25* 
IEC 60601-2-27* 
IEC 60601-2-33  
IEC 60601-2-36* 
IEC 60601-2-37* 
IEC 80601-2-30
IEC 60601-2-47* 
IEC 61010-1 * 

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-99 VPI Laboratories, Inc. Basic safety and essential performance Utah / United States Jason Stewart
jasons@vpitech.com
313 W 12800 S, Suite 311
Draper, UT 84020

ANSI AAMI ES60601-1*
IEC 60601-1-11
IEC 60601-1-2*
IEC 61010-1*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-100 INTERTEK SEMKO AB Basic safety and essential performance Sweden John Quigley
john.quigley@intertek.com
Torshamnsgatan 43
Stockholm 16440, Sweden

ANSI AAMI ES60601-1
IEC 60601-1-6
IEC 60601-1-8
IEC 61010-1
ISO 80601-2-12
ISO 80601-2-13
ISO 80601-2-55
TL-101 Intertek Japan K.K Matsuda Laboratory Basic safety and essential performance Japan John Quigley
john.quigley@intertek.com
1283 Yadoriki, Matsuda
Ashigarakami-gun, Kanagawa 258-0001
Japan

IEC 60601-1-2*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-102 Intertek Japan K.K Kashima Laboratory Basic safety and essential performance Japan John Quigley
john.quigley@intertek.com
298-6, Sada
Kashima, Ibaraki 314-0027
Japan

IEC 60601-1-2*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-103 UL International Italia S.r.l. Basic safety and essential performance Italy Pamela Gwynn
Pamela.K.Gwynn@ul.com
Via delle Industrie, 5 & 6 
20061 Carugate (MI)
Italy

ANSI AAMI ES60601-1*
IEC 60601-1-2
IEC 60601-1-6
IEC 61010-1*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-104 Elettra S.r.l. Basic safety and essential performance Italy Lorenzo Spinelli
l.spinelli@elettrasrl.eu
via Matteucci, 10,
50041 Calenzano (FI)
Italy

IEC 60601-1-6
IEC 60601-2-5
IEC 60601-2-6
IEC 60601-2-16
IEC 60601-2-57
ISO 80601-2-12
ISO 80601-2-13
ISO 80601-2-59
ISO 80601-2-72
ISO 80601-2-79
ISO 80601-2-80

TL-107

UL Japan, Inc. – Ise EMC Laboratory

Basic safety and essential performance

Japan

Masanori Nishiyama
Masanori.Nishiyama@ul.com
4383-326 ASAMA-CHO
ISE-SHI, MIE 516-0021
JAPAN

IEC 60601-1-2
TL-108 DLS Electronic Systems, Inc. Basic safety and essential performance Illinois / United States Blair Gannegan
bgannegan@dlsemc.com
1250 Peterson Drive
Wheeling, Illinois 60090

IEC 60601-1-2
IEC 61010-1

TL-114

Sigma Scientific Services LLC

Basic safety and essential performance

Florida / United States

Jorge Millan
jmillan@sigmabiomedical.com
7737 N University Drive Suite 101
Tamarac, Florida 33321

ANSI AAMI ES60601- 1*
ANSI/AAMI HA60601-1-11*
IEC 60601-1-11*
IEC 60601-2-5*
IEC 60601-2-37*
IEC 60601-2-62*
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.

TL-111

TÜV Rheinland Taiwan Ltd.

Basic safety and essential performance

Taiwan

Jon S.C. Lin
jon.lin@tuv.com
11F., No. 758, Sec. 4, Bade Rd., Songshan Dist., Taipei 105,
Taiwan

ANSI AAMI ES60601-1*
IEC 60601-1-6*
IEC 60601-1-8*
IEC 60601-1-10*
IEC 60601-1-11*
IEC 60601-2-10*
IEC 60601-2-18*
IEC 60601-2-22*
IEC 60601-2-25*
IEC 60601-2-27*
IEC 60601-2-47*
IEC 60601-2-52*
IEC 60601-2-57*
IEC 80601-2-30*
IEC 80601-2-35*
ISO 80601-2-56*
IEC 80601-2-60*
ISO 80601-2-61*
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.

TL-115

TÜV Rheinland (Shanghai) Co., Ltd.

Basic safety and essential performance

China

Audrey Zhao
Audrey.Zhao@tuv.com
Shanghai TUV Rheinland Building, 1/F. of No.10,
No.153 / 165 / 177 / 178 / 179 / 182 / 189 / 192 / 198,
Lane 777 Guangzhong West Road, Jing'an District
Shanghai, People's Republic of China 200072

ANSI AAMI ES60601-1*
IEC 60601-1-3*
IEC 60601-1-6*
IEC 60601-1-8*
IEC 60601-1-11*
ANSI AAMI HA60601-1-11*
IEC 60601-2-10*
ISO 80601-2-13*
IEC 60601-2-16*
IEC 60601-2-18*
IEC 60601-2-22*
IEC 60601-2-25*
IEC 60601-2-27*
IEC 60601-2-28*
IEC 80601-2-30*
IEC 60601-2-33*
IEC 60601-2-37*
IEC 60601-2-43*
IEC 60601-2-44*
IEC 60601-2-45*
IEC 60601-2-52*
IEC 60601-2-54*
ISO 80601-2-56*
IEC 80601-2-60*
IEC 60601-2-63*
IEC 60601-2-65*
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-116 TÜV SÜD Japan Ltd. Tokyo Testing Center Basic safety and essential performance Japan Toshiyuki Tamori
Toshiyuki.Tamori@tuvsud.com
NF Park Bldg, 4F 2-9-15 Futaba,
Shinagawa-ku, Tokyo 142-0043 | Japan

ANSI AAMI ES60601-1*
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11*
IEC 60601-2-5
IEC 60601-2-16*
IEC 60601-2-18
IEC 60601-2-19*
IEC 60601-2-20*
IEC 60601-2-21*
IEC 60601-2-22
IEC 60601-2-25*
IEC 60601-2-27*
IEC 60601-2-37*
IEC 60601-2-47
IEC 80601-2-60
ISO 80601-2-74*
IEC 61010-1*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-117 Eurofins E&E Wireless Taiwan Co., Ltd. Basic safety and essential performance Taiwan Misty Wu
mistywu@eurofins.com
No.140-1, Changan Street, Bade District
Taoyuan City, 334025, Taiwan (R.O.C.)

EMC Testing Only:

IEC 60601-1-2
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-2
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-47
IEC 80601-2-30
IEC 80601-2-60
ISO 80601-2-61
TL-105 TÜV Rheinland (Shenzhen) Co., Ltd. Basic safety and essential performance China Gina Yang
Gina.yang@tuv.com
1601-1604, 17-18F, Tower A Building 2, 
Shenzhen International Innovation Valley, 
Dashi 1st Road, Xili Street, Xili Community, 
Nanshan District, Shenzhen 518052
 

ANSI AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-10
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-1-2*
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-10
IEC 60601-2-16
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-22
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-37
IEC 60601-2-45
IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-54
IEC 60601-2-57
IEC 60601-2-63
IEC 60601-2-65
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-35
IEC 80601-2-60
IEC 80601-2-77
ISO 80601-2-12
ISO 80601-2-56
ISO 80601-2-61
ISO 80601-2-69
ISO 80601-2-70
ISO 80601-2-72
ISO 80601-2-74
ISO 80601-2-79
ISO 80601-2-80
TL-95 Eurofins Biolab Srl Biocompatibility Italy Francesca Salvatori, PhD
InfoMedicalDevice@eurofins.com
Via Bruno Buozzi, 2
20055 - VIMODRONE (MI)
Italy

ISO 10993-5 MEM Elution Cytotoxicity
ISO 10993-12 Sample preparation for the above test methods

TL-106

WuXi AppTec St. Paul

Biocompatibility

United States

Gabe J. Lebrun
Gabe.LeBrun@wuxiapptec.com
2540 Executive Drive, St. Paul, MN 55120

ISO 10993-5 MEM Elution Cytotoxicity
ISO 10993-12 Sample preparation for the above test methods

TL-83

WuXi AppTec Suzhou

Biocompatibility

China

Shirley Chan
ASCA@wuxiapptec.com
No. 818 Wusong Road, Wuzhong District
Suzhou, Jiangsu, China 215124

ISO 10993-4 and ASTM F756 Direct and Indirect Hemolysis
ISO 10993-5 MEM Elution Cytotoxicity
ISO 10993-12 Sample preparation for the above test methods

TL-123

Eurofins Electrical and Electronic Testing NA, Inc. - Irvine

Basic safety and essential performance

California / United States

Greg Kovolenko
greg.kovolenko@metlabs.com
33439 Western Avenue
Union City, CA 94587

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] *
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)  *
ANSI AAMI HA60601-1-11:2015 
ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] 
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 
IEC 60601-1-10 Edition 1.1 2013-11 
IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION 
IEC 60601-1-11 Edition 2.0 2015-01 
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 
IEC 60601-1-12 Edition 1.0 2014-06 
IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION 
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 
IEC 60601-1-3 Edition 2.1 2013-04 
IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION 
IEC 60601-1-6 Edition 3.1 2013-10 
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION 
IEC 60601-1-8 Edition 2.1 2012-11 
IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 
IEC 60601-2-1 Edition 3.1 2014-07 
IEC 60601-2-1 Edition 4.0 2020-10 
IEC 60601-2-10 Edition 2.1 2016-04 
IEC 60601-2-16 Edition 5.0 2018-4 
IEC 60601-2-18: Edition 3.0 2009-08 
IEC 60601-2-2 Edition 6.0 2017-03 *
IEC 60601-2-22 Edition 3.1 2012-10 
IEC 60601-2-25 Edition 2.0 2011-10 
IEC 60601-2-27 Edition 3.0 2011-03 
IEC 60601-2-34 Edition 3.0 2011-05 
IEC 60601-2-37 Edition 2.1 2015 *
IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION 
IEC 60601-2-43 Edition 3.0 2022-12 
IEC 60601-2-44 Edition 3.2: 2016 
IEC 60601-2-45 Edition 3.1 2015 
IEC 60601-2-47 Edition 2.0 2012-02 
IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION 
IEC 60601-2-54 Edition 2.0 2022-09 
IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION 
IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION 
IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION 
IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION 
IEC 60601-2-68 Edition 1.0 2014-09 
IEC 80601-2-30: Edition 2.0 2018-03 
IEC 80601-2-35 Edition 2.1 2016-04 
IEC 80601-2-58 Edition 2.0 2014-09 
IEC 80601-2-60 Edition 2.0 2019-06 *
IEC 80601-2-77 Edition 1.0 2019-07 -
ISO 80601-2-12 First edition 2011-04-15 
ISO 80601-2-12 Second edition 2020-02 
ISO 80601-2-55 Second edition 2018-02 
ISO 80601-2-56 Second edition 2017-03 
ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) 
ISO 80601-2-69 First edition 2014-07-15 *
ISO 80601-2-69 Second edition 2020-11 *
ISO 80601-2-70 First Edition 2015-01-15 
ISO 80601-2-70 Second edition 2020-11 
ISO 80601-2-72 First edition 2015-04-11 
ISO 80601-2-74 First edition 2017-05 *
ISO 80601-2-79 First edition 2018-07 
ISO 80601-2-80 First edition 2018-07 
ISO 80601-2-84 First edition 2020-07 
ISO 80601-2-87 First edition 2021-04 
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-120 UL Verification Services, Inc.  (Fremont - EMC Lab) Basic safety and essential performance California / United States Edgard Rincand
edgard.rincand@ul.com 
47173 BENICIA STREET
Fremont, CA 94538 
 

IEC 60601-1-2 Edition 4.0 2014-02
IEC /TR 60601-4-2 Edition 1.0 2016-05
IEC 60601-1-2 Edition 4.1 2020-09 
IEC 60601-2-2 Edition 6.0 2017-03*
IEC 60601-2-5: Edition 3.0 2009-07*
IEC 60601-2-6 Edition 2.1 2016-04*
IEC 60601-2-10 Edition 2.1 2016-04*
IEC 60601-2-16 Edition 5.0 2018-4*
IEC 60601-2-18: Edition 3.0 2009-08* 
IEC 60601-2-19 Edition 3.0 2020-09* 
IEC 60601-2-20 Edition 3.0 2020-09* 
IEC 60601-2-21 Edition 3.0 2020-09* 
IEC 60601-2-23 Edition 3.0 2011-02* 
IEC 60601-2-25 Edition 2.0 2011-10* 
IEC 60601-2-27 Edition 3.0 2011-03* 
IEC 60601-2-31 Edition 2.1 2011-09* 
IEC 60601-2-33 Ed. 3.2 b:2015*
IEC 60601-2-34 Edition 3.0 2011-05* 
IEC 60601-2-36 Edition 2.0 2014-04* 
IEC 60601-2-37 Edition 2.1 2015*
IEC 60601-2-44 Edition 3.2: 2016* 
IEC 60601-2-45 Edition 3.1 2015* 
IEC 60601-2-47 Edition 2.0 2012-02* 
IEC 60601-2-50 Edition 3.0 2020-09* 
IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION* 
IEC 60601-2-62 Edition 1.0 2013-07* 
IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION *
IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION *
IEC 80601-2-77 Edition 1.0 2019-07*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-121 MEDTRONIC PLC. (RELIABILITY ASSURANCE & DESIGN ASSURANCE LABORATORIES) Basic safety and essential performance Minnesota / United States Michael Simpeh, Sr
michael.simpeh@medtronic.com
7000 Central Ave NE
Fridley Minnesota 55432

IEC 60601-1*
ANSI AAMI ES60601-1 *
*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-122 Eurofins Electrical Testing Service (Shanghai) Co., Ltd. Basic safety and essential performance Shanghai / China June Fan
june.fan@cpt.eurofinscn.com
Building 18, No. 2168 Chenghang Highway
Shanghai China

IEC 61010-1 Edition 3.1 2017-01 *
IEC 60601-1 Edition 3.2 2020-08 *
ANSI UL 61010-1 3rd Ed. *
ISO 80601-2-61 Second edition 2017-12 *
ISO 80601-2-69 First edition 2014-07-15*
ISO 80601-2-12 Second edition 2020-02 *
IEC 60601-1-6 Edition 3.2 2020-07 
IEC 60601-2-20 Edition 3.0 2020-09 *
IEC 60601-2-50 Edition 2.1 2016-04*
IEC 60601-2-65 Edition 1.1 2017-05 *
ANSI AAMI ES60601-1*
IEC 60601-2-54 Edition 1.2 2018-06*
IEC 60601-2-54 Edition 2.0 2022-09*
ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021]*
ANSI AAMI HA60601-1-11:2015*
IEC 60601-2-19 Edition 2.1 2016-04*
IEC 60601-1-11 Edition 2.0 2015-01
IEC 60601-2-20 Edition 2.1 2016-04 *
IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION
IEC 60601-2-52 Edition 1.0 2009-12*
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
IEC 60601-1-6 Edition 3.1 2013-10 
IEC 60601-1-8 Edition 2.2 2020-07 
IEC 60601-1-8 Edition 2.1 2012-11
IEC 60601-2-2 Edition 6.0 2017-03 *
IEC 60601-2-19 Edition 3.0 2020-09*
IEC 60601-2-21 Edition 2.1 2016-04 *
IEC 60601-2-21 Edition 3.0 2020-09 *
ISO 80601-2-69 Second edition 2020-11*
IEC 60601-2-18: Edition 3.0 2009-08*
IEC 60601-2-47 Edition 2.0 2012-02*
ISO 80601-2-74 First edition 2017-05*
IEC 60601-2-63 Edition 1.2 2021-05 *
IEC 60601-2-50 Edition 3.0 2020-09*
ISO 80601-2-12 First edition 2011-04-15*
IEC 60601-2-27 Edition 3.0 2011-03*
ISO 80601-2-56 Second edition 2017-03*
IEC 60601-2-63 Edition 1.1 2017-07 *
IEC 80601-2-30: Edition 2.0 2018-03*
IEC 60601-2-28 Edition 3.0 2017-06*
IEC 80601-2-60 Edition 2.0 2019-06*
IEC 60601-2-25 Edition 2.0 2011-10*
IEC 60601-2-45 Edition 3.1 2015*
IEC 60601-2-44 Edition 3.2: 2016*
IEC 60601-2-37 Edition 2.1 2015*
ISO 80601-2-55 Second edition 2018-02* 
IEC 60601-2-65 Edition 1.2 2021-05 *
IEC 60601-2-10 Edition 2.1 2016-04 *
IEC 60601-2-57 Edition 1.0 2011-01*
IEC 60601-2-22 Edition 3.1 2012-10*
IEC 60601-2-34 Edition 3.0 2011-05*

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-119 Eurofins Electrical and Electronic Testing NA, Inc. - Santa Clara Basic safety and essential performance California / United States Greg Kovolenko
greg.kovolenko@metlabs.com
33439 Western Avenue
Union City, CA 94587

IEC 60601-1-2
TL-124 Criterion, a Biotex, Inc. Service Basic safety and essential performance Texas / United States Nathan Slota
nathan.slota@biotexmedical.com
114 Holmes Rd.
Houston, Texas 77045

ANSI AAMI ES60601-1 *
IEC 60601-1 *
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8 *
ANSI AAMI HA60601-1-11 *
IEC 60601-1-12 *
IEC 60601-2-18
IEC 60601-2-22
IEC 80601-2-56

*Standard includes exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
 
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