U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Standards and Conformity Assessment Program
  5. ASCA-Accredited Testing Laboratories
  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 the ASCA Pilot 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 the ASCA Pilot. Please check the Recognized Consensus Standards database for the currently recognized versions.
  • Some FDA-recognized consensus standards included in the ASCA Pilot have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). For the standards included in the ASCA Pilot, the identical U.S. adoptions to ISO and IEC standards will also be accepted.
Some table information

Filters

ASCA ID# Organization Name ASCA Category Expiration Date State / Country Point of Contact Current Scope of ASCA Accreditation
TL-10 UL JAPAN, INC. Basic safety and essential performance 09/30/2022 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 CertifiGroup Inc. Basic safety and essential performance 09/30/2022 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 60601-1-6 
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 60601-2-52 
IEC 60601-2-65
IEC 61010-1 
TL-12 UL INTERNATIONAL POLSKA SP. Z.O.O. Basic safety and essential performance 09/30/2022 Poland Pamela Gwynn
Pamela.K.Gwynn@ul.com
RÓWNOLEGŁA 4, WARSZAWA 02-235, REPUBLIC OF POLAND

ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
IEC 60601-1-11
IEC 60601-1-6
IEC 60601-2-10
IEC 60601-2-18
IEC 60601-2-52
IEC 60601-2-57
IEC 61010-1
IEC 80601-2-60
ISO 80601-2-74 
TL-13 UL International Germany GmbH Basic safety and essential performance 09/30/2022 Germany Pamela Gwynn
Pamela.K.Gwynn@ul.com
Admiral Rosendahl Strasse 23, Neu Isenburg 62263, Germany

ANSI/AAMI ES60601-1
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-10 *
IEC 60601-2-18
IEC 60601-2-2
IEC 60601-2-25
IEC 60601-2-28
IEC 60601-2-43
IEC 60601-2-47
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-14 TÜV SÜD America, Inc. - Peabody Basic safety and essential performance 09/30/2022 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 09/30/2022 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 60601-1-10 *
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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 60601-1-6
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 60601-2-44
IEC 60601-2-47
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
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
TL-24 UL LLC - Melville Basic safety and essential performance 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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

* Standards include exclusions on the scope of accreditation from the accrediting body. Contact the test lab for more information.
TL-28 UL LLC - Fremont Basic safety and essential performance 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 /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 09/30/2022 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 09/30/2022 California / United States sdsales@nemko.com
2210 Faraday Ave, Suite 150, Carlsbad, CA 92008

ANSI/AAMI ES60601-1
IEC 60601-1-10
IEC 60601-1-12
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 09/30/2022 Texas / United States Stephanie Gruhn
stephanie.gruhn@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 09/30/2022 Maryland / United States Stephanie Gruhn
stephanie.gruhn@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 09/30/2022 California / United States Stephanie Gruhn
stephanie.gruhn@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 09/30/2022 California / United States Abdool Azaad
abdool.azaad@csagroup.org
34 Bunsen, Irvine, CA 92618

IEC 60601-1-11
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 60601-2-27
IEC 60601-2-31
IEC 60601-2-37
IEC 61010-1
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 09/30/2022 Japan Abdool Azaad
abdool.azaad@csagroup.org
5-40-6 Koishikawa, Tokyo, 112-0002, Japan

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 09/30/2022 Canada Abdool Azaad
abdool.azaad@csagroup.org
865 Ellingham Avenue, Pointe-Claire, Quebec H9R5E8, Canada

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 
TL-50 CSA Group Testing & Certification Inc. - Richmond Basic safety and essential performance 09/30/2022 Canada Abdool Azaad
abdool.azaad@csagroup.org
13799 Commerce Parkway, Richmond, British Columbia V6V 2N9, Canada

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 09/30/2022 Canada Abdool Azaad
abdool.azaad@csagroup.org
178 Rexdale Blvd., Toronto, ON, M9W 1R3, Canada

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 09/30/2022 South Korea Abdool Azaad
abdool.azaad@csagroup.org
52 Chungmin-Ro, Songpa-Gu, Seoul, 05839, Republic of Korea

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 60601-2-33
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 60601-2-54
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 09/30/2022 China Abdool Azaad
abdool.azaad@csagroup.org
Floor1 , Bldg. 4, 889 Yishan Road, Qilai Industrial City, Shanghai, China

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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 Massachusetts / United States Barry Wyshogrod
barry.wyshogrod@philips.com
3000 Minuteman Road, Suite 201, Andover, MA 01810

IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-23 EMC testing only as per sub-clauses 201.17 and 202;
IEC 60601-2-25
IEC 60601-2-27
IEC 60601-2-34
IEC 60601-2-37 EMC testing only as per sub-clauses 201.17 and 202.6;
IEC 60601-2-47
IEC 80601-2-30 *
ISO 80601-2-55
ISO 80601-2-56 *
ISO 80601-2-61 *
ANSI/AAMI HA60601-1-11 *
IEC 60601-1-11 *
IEC 60601-1-12 *
IEC 60601-1-2 *
ANSI/AAMI ES60601-1*

* 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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-68 UL Verification Services (Guangzhou) Co., Ltd., Song Shan
Lake Branch		 Basic safety and essential performance 09/30/2022 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  09/30/2022 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  09/30/2022 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  09/30/2022 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  09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 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 09/30/2022 California/United States Jeff Klinger
jeff@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 09/30/2022 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 09/30/2022 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 10993-10     Dermal Irritation
ISO 10993-10     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 09/30/2022 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

09/30/2022

 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 09/30/2022 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 09/30/2022 China Laura Cortes
Laura.cortes@baclcorp.com
No 12, Pulong East 1st Road
Tangxia Town
Dongguan, Guangdong 523719
People's Republic of China

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 09/30/2022 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 09/30/2022 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 60601-1-2
IEC 60601-1-3
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 60601-2-2
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 60601-2-36
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 09/30/2022 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 09/30/2022 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 09/30/2022 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 9/30/2022 Israel Michael Brun
brun@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 9/30/2022 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 IEC 60601-1-8
ANSI/AAMI HA 60601-1-11
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2-2
ANSI AAMI 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
ANSI AAMI IEC 60601-2-27
IEC 60601-2-37
IEC 60601-2-47
ANSI AAMI IEC 60601-2-47
IEC 60601-2-52
IEC 60601-2-57
IEC 60601-2-62
IEC 61010-1
IEC 80601-2-30
IEC 80601-2-60
ISO 80601-2-61
TL-97 TÜV Rheinland (China) Ltd. Basic safety and essential performance 9/30/2022 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
TL-99 VPI Laboratories, Inc. Basic safety and essential performance 9/30/2022 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 9/30/2022 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 9/30/2022 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 9/30/2022 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.
Back to Top