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  1. Standards and Conformity Assessment Program

ASCA-Recognized Accreditation Bodies

This page lists ASCA-recognized accreditation bodies along with 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: For the standards included in the ASCA Pilot, the identical United States (U.S.) adoptions to ISO and IEC standards will be accepted. There are FDA-recognized consensus standards included in the ASCA Pilot that have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). For the complete list of identical U.S. adoptions included in the ASCA pilot, refer to the recognized standards database. ASCA standards are listed by the standards development organization.

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
Gaithersburng 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
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