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  1. Standards and Conformity Assessment Program

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.
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-14 TÜV SÜD America, Inc. - Peabody Basic safety and essential performance Massachusetts / United States Barry Quinlan
Barry.Quinlan@tuvsud.com
10 Technology Dr, Peabody, MA 01960

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 60601-2-19 *
IEC 60601-2-20 *
IEC 60601-2-21 *
IEC 60601-2-25 *
IEC 60601-2-27 *
IEC 60601-2-34 *
IEC 60601-2-47 *
IEC 61010-1 *
IEC 80601-2-30
IEC 80601-2-60
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-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 *
IEC 60601-2-52 *
IEC 60601-2-54 *
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 *
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 60601-1-11
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 60601-2-54
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-7 UL LLC - Brea Basic safety and essential performance California / United States Pamela Gwynn
Pamela.K.Gwynn@ul.com
1075 West Lambert Road, Unit B, Brea, California 92821

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-6
IEC 60601-2-10
IEC 60601-2-57
IEC 61010-1
IEC 80601-2-60
ISO 80601-2-74 *

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
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-87 Bay Area Compliances Laboratories Corporation (Dongguan) Basic safety and essential performance China Laura Cortes
Laura.cortes@baclcorp.com
No 12, Pulong East 1st Road
Tangxia Town
Dongguan, Guangdong 523719
People's Republic of China

This test lab and all standards below are suspended as of March 28, 2022

ANSI AAMI ES60601-1
ANSI AAMI HA60601-1-11
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-47
IEC 80601-2-30
ISO 80601-2-56
ISO 80601-2-61
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*
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 60601-2-36*
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*

*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 Riccardo Pitteri, 8
20134 Milano (MI) 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-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-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 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.
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