This page lists ASCA-recognized accreditation bodies and their respective scopes of recognition. To see the current status and historical record for each accreditation body's scope of recognition, click the plus (+) button beside the ASCA ID#.
Note: 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.
ASCA ID#
Accreditation Body Name
ASCA Category
State
Point of Contact
Current Scope of ASCA recognition
AB-11
A2LA
Biocompatibility, Basic safety and essential performance
Maryland
Megan McConnellmmcconnell@a2la.org
5202 Presidents CT, Suite 220
Frederick, MD 21703
ANSI/AAMI ES60601-1 - All test methods;
ANSI/AAMI HA60601-1-11 - All test methods;
IEC 60601-1-10 - All test methods;
IEC 60601-1-11 - All test methods;
IEC 60601-1-12 - All test methods;
IEC 60601-1-2 - All test methods;
IEC 60601-1-3 - All test methods;
IEC 60601-1-6 - All test methods;
IEC 60601-1-8 - All test methods;
IEC 60601-2-1 - All test methods;
IEC 60601-2-10 - All test methods;
IEC 60601-2-11 - All test methods;
IEC 60601-2-16 - All test methods;
IEC 60601-2-17 - All test methods;
IEC 60601-2-18 - All test methods;
IEC 60601-2-19 - All test methods;
IEC 60601-2-2 - All test methods;
IEC 60601-2-20 - All test methods;
IEC 60601-2-21 - All test methods;
IEC 60601-2-22 - All test methods;
IEC 60601-2-23 - All test methods;
IEC 60601-2-25 - All test methods;
IEC 60601-2-27 - All test methods;
IEC 60601-2-28 - All test methods;
IEC 60601-2-29 - All test methods;
IEC 60601-2-31 - All test methods;
IEC 60601-2-33 - All test methods;
IEC 60601-2-34 - All test methods;
IEC 60601-2-36 - All test methods;
IEC 60601-2-37 - All test methods;
IEC 60601-2-43 - All test methods;
IEC 60601-2-44 - All test methods;
IEC 60601-2-45 - All test methods;
IEC 60601-2-47 - All test methods;
IEC 60601-2-5 - All test methods;
IEC 60601-2-50 - All test methods;
IEC 60601-2-52 - All test methods;
IEC 60601-2-54 - All test methods;
IEC 60601-2-57 - All test methods;
IEC 60601-2-6 - All test methods;
IEC 60601-2-62 - All test methods;
IEC 60601-2-63 - All test methods;
IEC 60601-2-64 - All test methods;
IEC 60601-2-65 - All test methods;
IEC 60601-2-68 - All test methods;
IEC 60601-2-8 - All test methods;
IEC 61010-1 - All test methods;
IEC 80601-2-30 - All test methods;
IEC 80601-2-35 - All test methods;
IEC 80601-2-59 - All test methods;
IEC 80601-2-60 - All test methods;
IEC 80601-2-77 - All test methods;
IEC/TR IEC 60601-4-2 - All test methods;
ISO 10993-10 - Dermal Irritation, Intracutaneous Reactivity Irritation, and 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 all test types;
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 80601-2-12 - All test methods;
ISO 80601-2-13 - All test methods;
ISO 80601-2-55 - All test methods;
ISO 80601-2-56 - All test methods;
ISO 80601-2-61 - All test methods;
ISO 80601-2-69 - All test methods;
ISO 80601-2-70 - All test methods;
ISO 80601-2-72 - All test methods;
ISO 80601-2-74 - All test methods;
ISO 80601-2-79 - All test methods;
ISO 80601-2-80 - All test methods
AB-12
ANSI National Accreditation Board (ANAB)
Biocompatibility, Basic safety and essential performance
Indiana
Jason Stinejstine@anab.org
11617 Coldwater Road
Ft. Wayne, IN 46845
ANSI/AAMI ES60601-1 - All test methods;
ANSI/AAMI HA60601-1-11 - All test methods;
IEC 60601-1-10 - All test methods;
IEC 60601-1-11 - All test methods;
IEC 60601-1-12 - All test methods;
IEC 60601-1-2 - All test methods;
IEC 60601-1-3 - All test methods;
IEC 60601-1-6 - All test methods;
IEC 60601-1-8 - All test methods;
IEC 60601-2-1 - All test methods;
IEC 60601-2-10 - All test methods;
IEC 60601-2-11 - All test methods;
IEC 60601-2-16 - All test methods;
IEC 60601-2-17 - All test methods;
IEC 60601-2-18 - All test methods;
IEC 60601-2-19 - All test methods;
IEC 60601-2-2 - All test methods;
IEC 60601-2-20 - All test methods;
IEC 60601-2-21 - All test methods;
IEC 60601-2-22 - All test methods;
IEC 60601-2-23 - All test methods;
IEC 60601-2-25 - All test methods;
IEC 60601-2-27 - All test methods;
IEC 60601-2-28 - All test methods;
IEC 60601-2-29 - All test methods;
IEC 60601-2-31 - All test methods;
IEC 60601-2-33 - All test methods;
IEC 60601-2-34 - All test methods;
IEC 60601-2-36 - All test methods;
IEC 60601-2-37 - All test methods;
IEC 60601-2-43 - All test methods;
IEC 60601-2-44 - All test methods;
IEC 60601-2-45 - All test methods;
IEC 60601-2-47 - All test methods;
IEC 60601-2-5 - All test methods;
IEC 60601-2-50 - All test methods;
IEC 60601-2-52 - All test methods;
IEC 60601-2-54 - All test methods;
IEC 60601-2-57 - All test methods;
IEC 60601-2-6 - All test methods;
IEC 60601-2-62 - All test methods;
IEC 60601-2-63 - All test methods;
IEC 60601-2-64 - All test methods;
IEC 60601-2-65 - All test methods;
IEC 60601-2-68 - All test methods;
IEC 60601-2-8 - All test methods;
IEC 61010-1 - All test methods;
IEC 80601-2-30 - All test methods;
IEC 80601-2-35 - All test methods;
IEC 80601-2-59 - All test methods;
IEC 80601-2-60 - All test methods;
IEC 80601-2-77 - All test methods;
IEC/TR IEC 60601-4-2 - All test methods;
ISO 10993-10 - Dermal Irritation, Intracutaneous Reactivity Irritation, and 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 all test types;
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 80601-2-12 - All test methods;
ISO 80601-2-13 - All test methods;
ISO 80601-2-55 - All test methods;
ISO 80601-2-56 - All test methods;
ISO 80601-2-61 - All test methods;
ISO 80601-2-69 - All test methods;
ISO 80601-2-70 - All test methods;
ISO 80601-2-72 - All test methods;
ISO 80601-2-74 - All test methods;
ISO 80601-2-79 - All test methods;
ISO 80601-2-80 - All test methods
AB-13
National Voluntary Laboratory Accreditation Program (NVLAP)
Basic safety and essential performance
Maryland
Amanda McDonaldAmanda.McDonald@NIST.gov
100 Bureau Drive MS2140
Gaithersburg MD 20899
ANSI/AAMI ES60601-1 - All test methods;
ANSI/AAMI HA60601-1-11 - All test methods;
IEC 60601-1-10 - All test methods;
IEC 60601-1-11 - All test methods;
IEC 60601-1-12 - All test methods;
IEC 60601-1-2 - All test methods;
IEC 60601-1-3 - All test methods;
IEC 60601-1-6 - All test methods;
IEC 60601-1-8 - All test methods;
IEC 60601-2-1 - All test methods;
IEC 60601-2-10 - All test methods;
IEC 60601-2-11 - All test methods;
IEC 60601-2-16 - All test methods;
IEC 60601-2-17 - All test methods;
IEC 60601-2-18 - All test methods;
IEC 60601-2-19 - All test methods;
IEC 60601-2-2 - All test methods;
IEC 60601-2-20 - All test methods;
IEC 60601-2-21 - All test methods;
IEC 60601-2-22 - All test methods;
IEC 60601-2-23 - All test methods;
IEC 60601-2-25 - All test methods;
IEC 60601-2-27 - All test methods;
IEC 60601-2-28 - All test methods;
IEC 60601-2-29 - All test methods;
IEC 60601-2-31 - All test methods;
IEC 60601-2-33 - All test methods;
IEC 60601-2-34 - All test methods;
IEC 60601-2-36 - All test methods;
IEC 60601-2-37 - All test methods;
IEC 60601-2-43 - All test methods;
IEC 60601-2-44 - All test methods;
IEC 60601-2-45 - All test methods;
IEC 60601-2-47 - All test methods;
IEC 60601-2-5 - All test methods;
IEC 60601-2-50 - All test methods;
IEC 60601-2-52 - All test methods;
IEC 60601-2-54 - All test methods;
IEC 60601-2-57 - All test methods;
IEC 60601-2-6 - All test methods;
IEC 60601-2-62 - All test methods;
IEC 60601-2-63 - All test methods;
IEC 60601-2-64 - All test methods;
IEC 60601-2-65 - All test methods;
IEC 60601-2-68 - All test methods;
IEC 60601-2-8 - All test methods;
IEC 61010-1 - All test methods;
IEC 80601-2-30 - All test methods;
IEC 80601-2-35 - All test methods;
IEC 80601-2-59 - All test methods;
IEC 80601-2-60 - All test methods;
IEC 80601-2-77 - All test methods;
IEC/TR IEC 60601-4-2 - All test methods;
ISO 80601-2-12 - All test methods;
ISO 80601-2-13 - All test methods;
ISO 80601-2-55 - All test methods;
ISO 80601-2-56 - All test methods;
ISO 80601-2-61 - All test methods;
ISO 80601-2-69 - All test methods;
ISO 80601-2-70 - All test methods;
ISO 80601-2-72 - All test methods;
ISO 80601-2-74 - All test methods;
ISO 80601-2-79 - All test methods;
ISO 80601-2-80 - All test methods
AB-14
International Acccreditation Service, Inc. (IAS)
Basic safety and essential performance
California
Dimitrios Katsierisdimitriosk@iasonline.org
3060 Saturn Street Suite 100
Brea CA 92821
ANSI/AAMI ES60601-1 - All test methods;
ANSI/AAMI HA60601-1-11 - All test methods;
IEC 60601-1-10 - All test methods;
IEC 60601-1-11 - All test methods;
IEC 60601-1-12 - All test methods;
IEC 60601-1-2 - All test methods;
IEC 60601-1-3 - All test methods;
IEC 60601-1-6 - All test methods;
IEC 60601-1-8 - All test methods;
IEC 60601-2-1 - All test methods;
IEC 60601-2-10 - All test methods;
IEC 60601-2-11 - All test methods;
IEC 60601-2-16 - All test methods;
IEC 60601-2-17 - All test methods;
IEC 60601-2-18 - All test methods;
IEC 60601-2-19 - All test methods;
IEC 60601-2-2 - All test methods;
IEC 60601-2-20 - All test methods;
IEC 60601-2-21 - All test methods;
IEC 60601-2-22 - All test methods;
IEC 60601-2-23 - All test methods;
IEC 60601-2-25 - All test methods;
IEC 60601-2-27 - All test methods;
IEC 60601-2-28 - All test methods;
IEC 60601-2-29 - All test methods;
IEC 60601-2-31 - All test methods;
IEC 60601-2-33 - All test methods;
IEC 60601-2-34 - All test methods;
IEC 60601-2-36 - All test methods;
IEC 60601-2-37 - All test methods;
IEC 60601-2-43 - All test methods;
IEC 60601-2-44 - All test methods;
IEC 60601-2-45 - All test methods;
IEC 60601-2-47 - All test methods;
IEC 60601-2-5 - All test methods;
IEC 60601-2-50 - All test methods;
IEC 60601-2-52 - All test methods;
IEC 60601-2-54 - All test methods;
IEC 60601-2-57 - All test methods;
IEC 60601-2-6 - All test methods;
IEC 60601-2-62 - All test methods;
IEC 60601-2-63 - All test methods;
IEC 60601-2-64 - All test methods;
IEC 60601-2-65 - All test methods;
IEC 60601-2-68 - All test methods;
IEC 60601-2-8 - All test methods;
IEC 61010-1 - All test methods;
IEC 80601-2-30 - All test methods;
IEC 80601-2-35 - All test methods;
IEC 80601-2-59 - All test methods;
IEC 80601-2-60 - All test methods;
IEC 80601-2-77 - All test methods;
IEC/TR IEC 60601-4-2 - All test methods;
ISO 80601-2-12 - All test methods;
ISO 80601-2-13 - All test methods;
ISO 80601-2-55 - All test methods;
ISO 80601-2-56 - All test methods;
ISO 80601-2-61 - All test methods;
ISO 80601-2-69 - All test methods;
ISO 80601-2-70 - All test methods;
ISO 80601-2-72 - All test methods;
ISO 80601-2-74 - All test methods;
ISO 80601-2-79 - All test methods;
ISO 80601-2-80 - All test methods
AB-15
Perry Johnson Laboratory Accreditation, Inc. (PJLA)
Biocompatibility, Basic safety and essential performance
Michigan
Tracy Szerszentszerszen@pjlabs.com
755 West Big Beaver Road, Suite 1325
Troy, MI 48084
ANSI/AAMI ES60601-1 - All test methods;
ANSI/AAMI HA60601-1-11 - All test methods;
IEC 60601-1-10 - All test methods;
IEC 60601-1-11 - All test methods;
IEC 60601-1-2 - All test methods;
IEC 60601-1-3 - All test methods;
IEC 60601-1-6 - All test methods;
IEC 60601-1-8 - All test methods;
IEC 60601-2-16 - All test methods;
IEC 60601-2-18 - All test methods;
IEC 60601-2-22 - All test methods;
IEC 60601-2-27 - All test methods;
IEC 60601-2-28 - All test methods;
IEC 60601-2-31 - All test methods;
IEC 60601-2-33 - All test methods;
IEC 60601-2-5 - All test methods;
IEC 60601-2-52 - All test methods;
IEC 60601-2-63 - All test methods;
IEC 60601-2-64 - All test methods;
IEC 60601-2-65 - All test methods;
IEC 61010-1 - All test methods;
IEC 80601-2-30 - All test methods;
IEC 80601-2-60 - All test methods;
IEC 80601-2-77 - All test methods;
ISO 10993-10 - Dermal Irritation, Intracutaneous Reactivity Irritation, and 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 all test types;
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 80601-2-56 - All test methods;
ISO 80601-2-61 - All test methods;
3/12/2021 - ISO 80601-2-80 - All test methods;
3/12/2021 - ISO 80601-2-79 - All test methods;
3/12/2021 - ISO 80601-2-74 - All test methods;
3/12/2021 - ISO 80601-2-72 - All test methods;
3/12/2021 - ISO 80601-2-70 - All test methods;
3/12/2021 - ISO 80601-2-69 - All test methods;
3/12/2021 - IEC 60601-2-2 - All test methods;
3/12/2021 - IEC 60601-2-47 - All test methods;
3/12/2021 - ISO 80601-2-55 - All test methods;
3/12/2021 - ISO 80601-2-13 - All test methods;
3/12/2021 - ISO 80601-2-12 - All test methods;
3/12/2021 - IEC 60601-2-45 - All test methods;
3/12/2021 - IEC 60601-2-44 - All test methods;
3/12/2021 - IEC 60601-2-43 - All test methods;
3/12/2021 - IEC 60601-2-37 - All test methods;
3/12/2021 - IEC 60601-2-36 - All test methods;
3/12/2021 - IEC 60601-2-34 - All test methods;
3/12/2021 - IEC 60601-2-19 - All test methods;
3/12/2021 - IEC 60601-2-1 - All test methods;
3/12/2021 - IEC/TR IEC 60601-4-2 - All test methods;
3/12/2021 - IEC 60601-2-29 - All test methods;
3/12/2021 - IEC 60601-1-12 - All test methods;
3/12/2021 - IEC 80601-2-59 - All test methods;
3/12/2021 - IEC 80601-2-35 - All test methods;
3/12/2021 - IEC 60601-2-11 - All test methods;
3/12/2021 - IEC 60601-2-25 - All test methods;
3/12/2021 - IEC 60601-2-8 - All test methods;
3/12/2021 - IEC 60601-2-68 - All test methods;
3/12/2021 - IEC 60601-2-23 - All test methods;
3/12/2021 - IEC 60601-2-10 - All test methods;
3/12/2021 - IEC 60601-2-21 - All test methods;
3/12/2021 - IEC 60601-2-62 - All test methods;
3/12/2021 - IEC 60601-2-6 - All test methods;
3/12/2021 - IEC 60601-2-57 - All test methods;
3/12/2021 - IEC 60601-2-54 - All test methods;
3/12/2021 - IEC 60601-2-20 - All test methods;
3/12/2021 - IEC 60601-2-50 - All test methods;
Content current as of:
01/13/2023