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  1. Standards and Conformity Assessment Program

ASCA-Recognized Accreditation Bodies

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 Expiration Date State Point of Contact Current Scope of ASCA recognition
AB-11 A2LA Biocompatibility, Basic safety and essential performance 09/30/2022 Maryland Terrianne Kohr
tkohr@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 09/30/2022 Indiana Jason Stine
jstine@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 09/30/2022 Maryland Amanda McDonald
Amanda.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) Biocompatibility, Basic safety and essential performance 09/30/2022 California Dimitrios Katsieris
dimitriosk@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 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-15 Perry Johnson Laboratory Accreditation, Inc. (PJLA) Biocompatibility, Basic safety and essential performance 09/30/2022 Michigan Tracy Szerszen
tszerszen@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;
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