This is to attest that

UL JAPAN, INC.

4383-326 ASAMA-CHO
ISE-SHI MIE-KEN 516-0021, JAPAN
Testing Laboratory TL-449
has met the requirements of AC89, IAS Accreditation Criteria for Testing Laboratories as well as the FDA ASCA
Program specifications, and has demonstrated compliance with ISO/IEC Standard 17025:2017, General
requirements for the competence of testing and calibration laboratories. This organization is accredited to provide theservices specified in the scope of accreditation.
Effective Date August 28, 2024

Issued under the authority of IAS management

UL JAPAN, INC.
www.ul.com

Contact Name Mamoru Murabayashi

Contact Phone +81-596-24-7191

Accredited to ISO/IEC 17025:2017
FDA ASCA Program

Effective Date August 28, 2024

FDA ASCA Program Scope
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical
Systems and Laboratory Medical Equipment
ANSI AAMI ES60601Medical electrical equipment - Part 1: General requirements for basic safety and
1:2005/(R)2012 &essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2
A1:2012,(2021)]
C1:2009/(R)2012 &A2:2010/(R)2012(Cons. Text) [Incl.
AMD2:2021][19-46]ANSI AAMI HA60601Medical Electrical Equipment -- Part 1-11: General requirements for basic safety
1-11:2015 [Including
and essential performance -- Collateral Standard: Requirements for medical
AMD1:2021]
electrical equipment and medical electrical equipment and medical electrical[19-47]systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
[Including Amendment1 (2021)]
ANSI AAMI IEC 60601- Medical Electrical Equipment - Part 1-8: General requirements for basic safety
1-8:2006 and A1:2012
and essential performance ¿ Collateral Standard: General requirements, tests[Including AMD 2:2021] and guidance for alarm systems in medical electrical equipment and medical[5-131]electrical systems [Including Amendment 2 (2021)]
ANSI AAMI IEC
Medical electrical equipment – Part 2-25: Particular requirements for the basic
60601-2safety and essential performance of electrocardiographs
25:2011/(R)2016[3-105]ANSI AAMI IEC 60601- Medical electrical equipment - Part 2-27: Particular requirements for the basic
2-27:2011(R)2016
safety and essential performance of electrocardiographic monitoring equipment[3-126]ANSI AAMI IEC
Medical electrical equipment - Part 2-47: Particular requirements for the basic
60601-2-47:
safety and essential performance of ambulatory electrocardiographic systems
2012/(R)2016[3-155]ANSI AAMI IEC
Medical electrical equipment - part 2-30: particular requirements for the basic
80601-2-30:2018safety and essential performance of automated non- invasive[3-123]
sphygmomanometers
IEC 60601-1-3 Edition
Medical electrical equipment - Part 1-3: General requirements for basic safety and2.2 2021-01
essential performance - Collateral Standard: Radiation protection in diagnostic XCONSOLIDATED
ray equipment
VERSION
TL-449UL JAPAN, INC.

Effective Date August 28, 2024

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IAS/ TL- FDA ASCA /100-1[12-336]
IEC 60601-1-6
Edition 3.2 2020-07
CONSOLIDATEDVERSION[5-132]
IEC 60601-1-8
Edition 2.2 2020-07
CONSOLIDATEDVERSION
5-131]IEC 60601-1-11
Edition 2.1 2020-07
CONSOLIDATEDVERSION[19-38]
IEC 60601-2-18:
Edition 3.0 2009-08[9-114]
IEC 60601-2-25
Edition 2.0 2011-10[3-105]
IEC 60601-2-27
Edition 3.0 2011-03[3-126]
IEC 60601-2-28
Edition 3.0 2017-06[12-309]
IEC 60601-2-34
Edition 3.0 2011-05[3-115]
IEC 60601-2-47
Edition 2.0 2012-02[3-155]
IEC 60601-2-63 Edition
1.2 2021-05
CONSOLIDATEDVERSION[12-339]
IEC 60601-2-65 Edition
1.2 2021-05
CONSOLIDATEDVERSION[12-340]
IEC 61010-1
Edition 3.1 2017-01
CONSOLIDATEDVERSION[19-34]TL-449UL JAPAN, INC.

Effective Date August 28, 2024

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IAS/ TL- FDA ASCA /100-1

Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability

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
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
Medical electrical equipment - part 2-18: particular requirements for the basic
safety and essential performance of endoscopic equipment
Medical electrical equipment – Part 2-25: Particular requirements for the basic
safety and essential performance of electrocardiographs
Medical electrical equipment - Part 2-27: Particular requirements for the basic
safety and essential performance of electrocardiographic monitoring equipment[Including: Corrigendum 1 (2012)]
Medical electrical equipment - part 2-28: particular requirements for the basic
safety and essential performance of x-ray tube assemblies for medical
diagnosis
Medical electrical equipment - part 2-34: particular requirements for the basic
safety and essential performance of invasive blood pressure monitoring
equipment
Medical electrical equipment - Part 2-47: Particular requirements for the basic
safety and essential performance of ambulatory electrocardiographic systems
Medical electrical equipment - Part 2-63: Particular requirements for the basic
safety and essential performance of dental extra-oral X-ray equipment

Medical electrical equipment - Part 2-65: Particular requirements for the basic
safety and essential performance of dental intra-oral-X-ray equipment

Safety requirements for electrical equipment for measurement, control, andlaboratory use - Part 1: General requirements

IEC 80601-2-30:
Edition 2.0 2018-03[3-123]

Medical electrical equipment - part 2-30: particular requirements for the basic
safety and essential performance of automated non- invasive
sphygmomanometers

Regular Scope
Electronic
Energy Star
ENERGY STAR program requirements product specification for audio/video
ENERGY STAR program requirements product specification for computers
ENERGY STAR program requirements product specification for displays
ENERGY STAR program requirements, product specification for imaging equipment
ENERGY STAR program requirements product specification for televisions
16 CFR 1263
Button cell and coin batteries and consumer products containing such batteries
ANIS/AAMI ES60601- Medical electrical equipment - part 1: general requirements for basic safety and1essential performance
ANSI/AAMI HA60601- Medical electrical equipment – part 1-11: general requirements for basic safety
1-11
and essential performance – collateral standard: requirements for medical
electrical equipment and medical electrical systems used in the home healthcare
environment
ANSI/AAMI/IEC
Medical electrical equipment - Part 1-8: General requirements for basic safety and60601-1-8
essential performance - Collateral Standard: General requirements, tests andguidance for alarm systems in medical electrical equipment and medical electricalsystems
ANSI/AAMI/IEC
Medical electrical equipment – part 2-25: particular requirements for the basic
60601-2-25
safety and essential performance of electrocardiographs
ANSI/AAMI/IEC
Medical electrical equipment – part 2-27: particular requirements for the basic
60601-2-27
safety and essential performance of electrocardiographic monitoring equipment
ANSI/AAMI/IEC
Medical electrical equipment – part 2-47: particular requirements for the basic
60601-2-47
safety and essential performance of ambulatory electrocardiographic systems
ANSI/AAMI/IEC 62304 Medical device software – Software life cycle processes
ANSI AAMI IEC
Medical electrical equipment - part 2-30: particular requirements for the basic
80601-2-30
safety and essential performance of automated non- invasive
sphygmomanometers
EN 50563
External a.c.. d.c. and a.c.. a.c. power supplies. Determination of no-load power
and average efficiency of active modes
EN 50564
Electrical and electronic household and office equipment – measurement of low
power consumption
EN 50564 2011
Electrical and electronic household and office equipment – measurement of low
power consumption
EN 60034-5
Rotating electrical machines – Part 5: Degrees of protection provided by the
integral design of rotating electrical machines (IP code) – Classification (IPX1,
IPX2, IPX3, IPX4, IPX5, IPX6, IPX7, IPX8, IP1X, IP2X, IP3X, IP4X, IP5X, IP6X)
EN 62087-1 2016
Audio, video, and related equipment – Determination of power consumption –Part 1: General
EN 62087-2 2016
Audio, video, and related equipment – Determination of power consumption –Part 2: Signals and media
EN 62087-3 2016
Audio, video, and related equipment – Determination of power consumption –Part 3: Television sets

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EN 62087-6 2016
ES 7993
IEC 60034-5
IEC 60068-2-1
IEC 60068-2-2
IEC 60068-2-6
IEC 60068-2-11
IEC 60068-2-13
IEC 60068-2-14
IEC 60068-2-27
IEC 60068-2-30
IEC 60068-2-31
IEC 60068-2-38
IEC 60068-2-52
IEC 60068-2-64
IEC 60068-2-78
IEC 60335-1
IEC 60335-2-84
IEC 60601-1
IEC 60601-1-11

IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-18
IEC 60601-2-28
IEC 60601-2-34

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Audio, video and related equipment – Determination of power consumption – Part
6: Audio equipment
Energy Efficiency Label for Television and Displays
Rotating electrical machines – Part 5: Degrees of protection provided by the
integral design of rotating electrical machines (IP code) – Classification (IPX1,
IPX2, IPX3, IPX4, IPX5, IPX6, IPX7, IPX8, IP1X, IP2X, IP3X, IP4X, IP5X, IP6X)
Environmental testing – Part 2-1: Tests – Test A: Cold
Environmental testing – Part 2-2: Tests – Test B: Dry heat
Environmental testing – Part 2-6: Tests – Test Fc: Vibration (sinusoidal)
Environmental testing – Part 2: Tests – Test Ka: Salt Mist
Basic environmental Testing procedures – Part 2-13: Tests - Test M: Low airpressure
Environmental testing – Part 2-14: Tests – Test N: Change of temperature –Edition 6.0 (Exception: Clause 9)
Environmental testing – Part 2-27: Tests – Test Ea and guidance: ShockEnvironmental testing – Part 2-30: Tests – Test Db: Damp heat, cyclic (12 h + 12
h cycle)Environmental testing – Part 2-31: Tests – Test Ec: Rough handling shocks,
primarily for equipment-type specimens
Environmental testing – Part 2-38: Tests – Test Z/AD: Composite
temperature/humidity cyclic test
Environmental testing – Part 2-52: Tests – Test Kb: Salt mist, cyclic (sodium
chloride solution) - Edition 3.0
Environmental testing – Part 2-64: Test methods – Test Fh – Vibration, broadband random (digital control) and guidance
Environmental testing – Part 2-78: Tests – Test Cab: Damp heat, steady state
Household and similar electrical appliances – Safety – Part 1: General
requirements
Household and similar electrical appliances – Safety – Part 2-84: Particularrequirements for toilet appliances
Medical electrical equipment – part 1: general requirements for basic safety andessential performance
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
Medical electrical equipment – Part 1-3: General requirements for basic safety
and essential performance – Collateral Standard: Radiation protection indiagnostic X-ray equipment
Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability
Medical electrical equipment – Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic equipment
Medical electrical equipment – Part 2-28: Particular requirements for the basic
safety and essential performance of X-ray tube assemblies for medical diagnosis
Medical electrical equipment – part 2-34: particular requirements for the basic
safety and essential performance of invasive blood pressure monitoring
equipment

IEC 60601-2-37
IEC 60601-2-51
IEC 60601-2-63
IEC 60601-2-65
IEC 61010-1
IEC 62087-1 2015 Ed
1.0
IEC 62087-2 2015 Ed
1.0
IEC 62087-3 2015 Ed
1.0
IEC 62087-6 2015 Ed
1.0
IEC 62301
IEC 62301 2011 Ed
2.0
IEC 62304
IEC 80601-2-30
IEC 80601-2-49
IEC 80601-2-60
IEC/EN 60065
IEC/EN 60086-1
IEC/EN 60086-2
IEC/EN 60086-4
IEC/EN 60086-5
IEC/EN 60204-1
IEC/EN 60529
IEC/EN 60950-1
IEC/EN 60950-22
IEC/EN 61960
IEC/EN 62087
IEC/EN 62368-1
IEC/EN 62368-3

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Medical electrical equipment – Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
Medical electrical equipment – part 2-51: particular requirements for safety,
including essential performance, of recording and analysing single channel andmultichannel electrocardiographs
Medical electrical equipment – Part 2-63: Particular requirements for the basic
safety and essential performance of dental extra-oral X-ray equipment
Medical electrical equipment – Part 2-65: Particular requirements for the basic
safety and essential performance of dental intra-oral X-ray equipment
Safety requirements for electrical equipment for measurement, control, andlaboratory use – Part 1: General requirements
Audio, video, and related equipment – Determination of power consumption –Part 1: General
Audio, video, and related equipment – Determination of power consumption –Part 2: Signals and media
Audio, video, and related equipment – Determination of power consumption –Part 3: Television sets
Audio, video and related equipment – Determination of power consumption – Part
6: Audio equipment
Household electrical appliances – measurement of standby power
Household electrical appliances – measurement of standby power
Medical device software – Software life cycle processes
Medical electrical equipment – part 2-30: particular requirements for the basic
safety and essential performance of automated non-invasive
sphygmomanometers
Medical electrical equipment – Part 2-49: Particular requirements for the basic
safety and essential performance of multifunction patient monitors
Medical electrical equipment – Part 2-60: Particular requirements for the basic
safety and essential performance of dental equipment
Audio, video and similar electronic apparatus – safety requirements
Primary batteries – general
Primary batteries – physical and electrical specifications
Primary batteries – part 4: safety of lithium batteries
Primary batteries – part 5: safety of batteries with aqueous electrolyte
Safety of machinery – Part 1: General requirements
Degrees of protection provided by enclosures (IP code) (IPX1, IPX2, IPX3, IPX4,
IPX5, IPX6, IPX7, IPX8, IP1X, IP2X, IP3X, IP4X, IP5X, IP6X)
Information technology equipment – safety – part 1: general requirements
Information technology equipment – Safety – Part 22: Equipment to be installed
outdoors
Secondary cells and batteries containing alkaline or other non-acid electrolytes secondary lithium cells and batteries for portable applications
Methods of measurement for the power consumption of audio, video and related
equipment
Audio/video, information and communication technology equipment – part 1:
safety requirements
Audio/video, information and communication technology equipment – Part 3:
Safety aspects for DC power transfer through communication cables and portsIEC/EN 62133
IEC/EN 62133-1
IEC/EN 62133-2
IEC/EN 62281
ISO 16750-1
ISO 16750-3
ISO 16750-4
ISO 16750-5
ISO 20653
MS 2576
PNS 378: 2000
UL 4200A

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Secondary cells and batteries containing alkaline or other non-acid electrolytes –safety requirements for portable sealed secondary cells, and for batteries madefrom them, for use in portable applications
Secondary cells and batteries containing alkaline or other non-acid electrolytes –safety requirements for portable sealed secondary cells, and for batteries madefrom them, for use in portable applications – Part 1: Nickel systems
Secondary cells and batteries containing alkaline or other non-acid electrolytes –safety requirements for portable sealed secondary cells, and for batteries madefrom them, for use in portable applications – Part 2: Lithium systems
Safety of primary and secondary lithium cells and batteries during transport
Road vehicles - Environmental conditions and testing for electrical and electronicequipment – Part 1: General
Road vehicles – Environmental conditions and testing for electrical and electronicequipment – Part 3: Mechanical loads – Third Edition
Road vehicles – Environmental conditions and testing for electrical and electronicequipment – Part 4: Climatic loads – Third Edition (Exception: Clause 5.8)
Road vehicles - Environmental conditions and testing for electrical and electronicequipment - Part 5: Chemical loads - Second Edition
Road vehicles – Degrees of protection (IP code) – Protection of electricalequipment against foreign objects, water and access – Second Edition
Minimum energy performance standards (MEPS) for television
Television Receivers and Video Monitors - Viewing Screen Dimensions - Methodof Measurement
Products incorporating button batteries or coin cell batteries