ASCA-Accredited Testing Laboratories

This page lists ASCA-accredited testing laboratories and their respective scopes of accreditation.

Notes:

Testing laboratories who wish to participate in ASCA should demonstrate that they have been accredited by an ASCA-recognized accreditation body to the currently FDA-recognized versions of the standards and test methods included in ASCA. Please check the Recognized Consensus Standards database for the currently recognized versions.

Some FDA-recognized consensus standards included in ASCA have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). If a testing laboratory has an international (e.g., IEC, ISO) version of a standard in their scope of ASCA Accreditation, any identical US adoption associated with the FDA Recognition number is also considered included in the testing laboratory's scope. For example, if IEC 60601-2-47 with FDA Recognition number 3-155 is listed in a testing laboratory's scope of ASCA Accreditation, testing to the associated ANSI AAMI IEC version is also acceptable even if it is not explicitly listed in the testing lab's scope.

Some FDA-recognized international consensus standards (e.g., IEC, ISO) included in ASCA are recognized specifically with U.S. national differences applied (e.g., IEC 60601-1, IEC 61010-1). When U.S. national differences are applied to the international versions, they are considered equivalent to the corresponding U.S. adoptions of those standards (e.g., ANSI AAMI ES60601-1, ANSI UL 61010-1). For testing laboratories listed below with such standards in their scope, both the US adoptions and the international versions of the standards are considered as part of their scope of ASCA Accreditation.

As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.

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Test Lab: TUV SUD America, Inc. - San Diego [TL-17]

Accreditation Status: Accreditation Granted - Date: 04/12/2021

Accreditation Body Organization Name: A2LA

Test Lab Primary Contact: William Elliott, William.Elliott@tuvsud.com, 10040 Mesa Rim Rd San Diego CA US 92121

Status	Status Date	Category	Biocompatibility Test Method	Recognition Number	Standards Development Organization	Standard Designation Number and Date	Title	Exclusions
Accreditation Granted	04/12/2021	Basic safety and essential performance		1-140	ISO	80601-2-55 Second edition 2018-02	Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		1-87	IEC	60601-2-23 Edition 3.0 2011-02	Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		12-211	IEC	60601-2-29 Edition 3.0 2008-06	Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		12-268	IEC	60601-2-22 Edition 3.1 2012-10	Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		17-16	IEC	60601-2-10 Edition 2.1 2016-04	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		19-34	IEC	61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		19-36	IEC	60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		19-37	IEC	60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		19-38	IEC	60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		19-39	IEC	60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		3-102	IEC	60601-2-31 Edition 2.1 2011-09	Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		3-105	IEC	60601-2-25 Edition 2.0 2011-10	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		3-115	IEC	60601-2-34 Edition 3.0 2011-05	Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		3-123	IEC	80601-2-30: Edition 2.0 2018-03	Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		3-126	IEC	60601-2-27 Edition 3.0 2011-03	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		3-155	IEC	60601-2-47 Edition 2.0 2012-02	Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		4-262	IEC	80601-2-60 Edition 2.0 2019-06	Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		5-131	IEC	60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		5-132	IEC	60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		6-321	IEC	60601-2-52 Edition 1.0 2009-12	Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		6-389	IEC	60601-2-2 Edition 6.0 2017-03	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		6-421	ISO	80601-2-56 Second edition 2017-03 [Including AMD1:2018]	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		9-114	IEC	60601-2-18: Edition 3.0 2009-08	Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Accreditation Granted	04/12/2021	Basic safety and essential performance		9-119	IEC	60601-2-36 Edition 2.0 2014-04	Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.

Scope History

Action Type	ASCA Status	Effective Start Date	Biocompatibility Test Method	Recognition Number	Designation Number	Exclusions
Transition	Inactive	12/17/2023		19-14	60601-1-11 Edition 2.0 2015-01	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		19-15	60601-1-12 Edition 1.0 2014-06	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		19-16	HA60601-1-11:2015	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		19-4	ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
Transition	Inactive	12/17/2023		19-8	60601-1-2 Edition 4.0 2014-02	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		19-9	60601-1-10 Edition 1.1 2013-11	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		5-76	60601-1-8 Edition 2.1 2012-11	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		5-89	60601-1-6 Edition 3.1 2013-10	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		6-385	60601-2-19 Edition 2.1 2016-04	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		6-386	60601-2-20 Edition 2.1 2016-04	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	12/17/2023		6-388	60601-2-21 Edition 2.1 2016-04	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.
Transition	Inactive	07/09/2023		1-98	80601-2-12 First edition 2011-04-15	Excluding the following measurements: Abrasion Resistance Test, Steel Pin, Concentration of Flammable Vapors, Softening Temperature (ISO 306), Ultrasonic Pressure, Capacitors and RC-units, Insulated Winding Wires, Methylated Spirits and Pressure Apparatus, Coated Printed Circuit Boards Test Apparatus (IEC 60664-3), CRT Strength, Ageing Test Apparatus for Elastomeric Parts, Partial Discharge Test (§2.10.5.4), UV Radiation, Bottom Fire Enclosure (hot flaming oil), Resistance to Ultra-violet Radiation, Resistance to Heat and Fire - ISO 9772 Test Apparatus, Microwave Radiation, AC Power Cords, (IEC 60227 flex), Oxygen Bomb, Endurance Test Apparatus (IEC 60384-14), Test Apparatus for Flammable Refrigerants, AP APG Tests (§ 37, 39, 41), ¿20 *Autoclave Tests (§ 44)¿, EO Sterilisation (§ 44), Gamma Sterilisation (§ 44), Power Measurements, ECG Performance, IR Irradiance, Vibration Test, Resistance to Corrosion, Water-borne Contaminants ¿ Salt Spray Test, Mechanical Strength (§ 21), Water-sulfur Dioxide Test, Compression Test, & Oil Immersion Test.