Status |
Status Date
|
Category
|
Biocompatibility Test Method
|
Recognition Number
|
Standards Development Organization |
Standard Designation Number and Date |
Title |
Exclusions |
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-105
|
ISO
|
80601-2-72 First edition 2015-04-11
|
Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-138
|
ISO
|
80601-2-74 First edition 2017-05
|
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
|
|
Accreditation Granted |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
Basic safety and essential performance |
|
1-141
|
ISO
|
80601-2-13 First edition 2011-08-11
|
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-143
|
ISO
|
80601-2-79 First edition 2018-07
|
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-144
|
ISO
|
80601-2-80 First edition 2018-07
|
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-146
|
ISO
|
80601-2-12 Second edition 2020-02
|
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-148
|
ISO
|
80601-2-69 Second edition 2020-11
|
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-151
|
ISO
|
80601-2-70 Second edition 2020-11
|
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-152
|
ISO
|
80601-2-87 First edition 2021-04
|
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
1-160
|
ISO
|
80601-2-84 First edition 2020-07
|
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
10-126
|
IEC
|
80601-2-58 Edition 2.0 2014-09
|
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-205
|
IEC
|
60601-2-5: Edition 3.0 2009-07
|
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-242
|
IEC
|
60601-2-57 Edition 1.0 2011-01
|
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-255
|
IEC
|
60601-2-11 Edition 3.0 2013-01
|
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-272
|
IEC
|
60601-2-17 Edition 3.0 2013-11
|
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-281
|
IEC
|
60601-2-62 Edition 1.0 2013-07
|
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-293
|
IEC
|
60601-2-37 Edition 2.1 2015
|
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-294
|
IEC
|
60601-2-45 Edition 3.1 2015
|
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-295
|
IEC
|
60601-2-33 Ed. 3.2 b:2015
|
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-301
|
IEC
|
60601-2-8 Edition 2.1 b:2015
|
Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-302
|
IEC
|
60601-2-44 Edition 3.2: 2016
|
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-309
|
IEC
|
60601-2-28 Edition 3.0 2017-06
|
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-318
|
IEC
|
60601-2-64 Edition 1.0 2014-09
|
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-319
|
IEC
|
60601-2-68 Edition 1.0 2014-09
|
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-329
|
IEC
|
60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-336
|
IEC
|
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-338
|
IEC
|
60601-2-1 Edition 4.0 2020-10
|
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-339
|
IEC
|
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-340
|
IEC
|
60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
|
|
Accreditation Granted |
12/27/2023 |
Basic safety and essential performance |
|
12-347
|
IEC
|
60601-2-33 Edition 4.0 2022-08
|
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
|
|
Accreditation Granted |
12/27/2023 |
Basic safety and essential performance |
|
12-348
|
IEC
|
60601-2-54 Edition 2.0 2022-09
|
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
12-351
|
IEC
|
60601-2-43 Edition 3.0 2022-12
|
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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 |
02/02/2024 |
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 subclauses 12.5.2, 13.2.3
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
19-46
|
ANSI, AAMI
|
ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
|
Excluding subclauses 8.8.4.2, Cl. 9.5.2, Cl. 11.7, Annex G (these also apply to related collaterals and particulars in scope)
|
Accreditation Granted |
02/02/2024 |
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 |
12/27/2023 |
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.
|
Excluding subclauses 8.8.4.2, Cl. 9.5.2, Cl. 11.7, Annex G
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
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
|
|
Accreditation Granted |
12/27/2023 |
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
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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)]
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
6-405
|
IEC
|
80601-2-59 Edition 2.0 2017-09
|
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
|
|
Accreditation Granted |
02/02/2024 |
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 |
02/02/2024 |
Basic safety and essential performance |
|
6-423
|
IEC
|
60601-2-6 Edition 2.1 2016-04
|
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
6-438
|
IEC
|
80601-2-77 Edition 1.0 2019-07
|
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
6-450
|
IEC
|
60601-2-50 Edition 3.0 2020-09
|
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
|
|
Accreditation Granted |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
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 |
02/02/2024 |
Basic safety and essential performance |
|
6-483
|
IEC
|
60601-2-35 Edition 2.0 2020-09
|
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
6-489
|
IEC
|
60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
|
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
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
|
|
Accreditation Granted |
02/02/2024 |
Basic safety and essential performance |
|
9-121
|
IEC
|
60601-2-16 Edition 5.0 2018-4
|
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
|
|