Status |
Status Date
|
Category
|
Biocompatibility Test Method
|
Recognition Number
|
Standards Development Organization |
Standard Designation Number and Date |
Title |
Exclusions |
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
1-139
|
ISO
|
80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
|
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
|
|
| Accreditation Granted |
11/21/2025 |
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
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
1-184
|
ISO
|
80601-2-55 Second edition 2018-02 [Including AMD1:2023]
|
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
|
|
| 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
17-22
|
IEC
|
60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
19-19
|
IEC
|
TR 60601-4-2 Edition 1.0 2016-05
|
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
|
|
| 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
19-41
|
ANSI, UL
|
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
|
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
19-47
|
AAMI, ANSI
|
HA60601-1-11:2015 [Including AMD1:2021]
|
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
19-49
|
IEC
|
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
19-50
|
IEC
|
TS 60601-4-2 Edition 1.0 2024-03
|
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
|
|
| 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
|
| Accreditation Granted |
11/21/2025 |
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
|
|
| Accreditation Granted |
11/21/2025 |
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
|
|
| Accreditation Granted |
11/21/2025 |
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
|
|
| Accreditation Granted |
11/21/2025 |
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)]
|
|
| Accreditation Granted |
11/21/2025 |
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
|
|
| 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
|
| Accreditation Granted |
11/21/2025 |
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)].
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
6-461
|
IEC
|
60601-2-19 Edition 3.0 2020-09
|
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
6-462
|
IEC
|
60601-2-20 Edition 3.0 2020-09
|
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
|
|
| Accreditation Granted |
11/21/2025 |
Basic safety and essential performance |
|
6-463
|
IEC
|
60601-2-21 Edition 3.0 2020-09
|
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
|
|
| 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: Abrasion Resistance Test, Bottom Fire Enclosure (Hot Flaming Oil), Cathode Ray Tubes, Concentration of Flammable Vapors, CRT Strength, Hand-Transmitted Vibration, High Vacuum Devices, Human Exposure to UV Radiation, Integrated Circuit (IC) Current Limiters, Ionizing Radiation, Laser (including laser diodes), Light Emitting Diodes (LEDs), Mandrel Test, Materials Group, Classification, Microwave Radiation, Partial Discharge Test, Pressure Vessels, Prevention of Electrostatic Charges, Resistance to Environmental Stress, Softening Temperature (ISO 306), Tracking Index CTI, Ultrasonic Pressure, UV Radiation, Oscillating Hoop IP Test, Dust Test, Shock and Vibration Test, Oxygen Bomb Test, & Altitude Test.
|
|