China

TUV Rheinland (Shenzhen) Co.,

2-3F, 101 & 102, No.2, Nuclear Power Industrial Park, Fuming Community, Fucheng Street, Longhua District, Shenzhen, 518000, People's Republic of China, Shenzhen, China

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A2LARefreshed 2026-09-25: 5162.01Active

Accredited standards

Our reading of the A2LA scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

IEC 60601 series

IEC 60601-1-2Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

As written on the certificate · Line 5 (A2LA 5162.01)

FCC OET 65, Supplement C; Australian Communications Authority “Radio communications” (Electromagnetic Radiation-Human Exposure) Standard 2001; IEEE 1528; IEC/IEEE 62209-1528; RSS-102; RSS-102.SAR.MEAS; RSS-102.NS.MEAS; EN 50360; EN 50364; EN 50383; EN 50384; EN 50385; EN 50566; EN 62311; EN 62369-1; EN 62479; EN 62209-1; EN 62209-2; IEC 62209-1; IEC 62209-2; EN 50663; EN 50401; ACMA Radio Communications Standard; MIC Notification No.324; IEC 60601-1-2; EN 60601-1-2; ANSI/AAMI IEC 60601-1-2; YY 0505; YY 9706.102; IEC TS 60601-4-2; ANSI C63.4:2014

As written on the certificate · Line 12 (A2LA 5162.01)

ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

IEC 60601-1-3Name not checked yet

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IEC 60601-1 Edition 3.2 2020-08; ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1-10 Edition 1.2 2020-07; IEC 60601-1-11 Edition 2.1 2020-07; ANSI/AAMI HA60601-1-11:2015; IEC 60601-1-12 Edition 1.1 2020-07; ANSI/AAMI IEC 60601-1-12:2016; IEC 60601-1-3 Edition 2.2 2021-01; IEC 60601-1-6 Edition 3.2 2020-07; IEC 60601-1-8 Edition 2.2 2020-07; ANSI/AAMI IEC 60601-1-8:2006; IEC 60601-2-10 Edition 2.1 2016-04; ISO 80601-2-13 Second edition 2022-04; ISO 80601-2-13 First edition 2011-08-11; IEC 60601-2-16 Edition 5.0 2018-4; ANSI/AAMI IEC 60601-2-16:2018; IEC 60601-2-18 Edition 3.0 2009-08; IEC 60601-2-19 Edition 3.0 2020-09; IEC 60601-2-2 Edition 6.0 2017-03; ANSI/AAMI IEC 60601-2-2:2017; IEC 60601-2-20 Edition 3.0 2020-09; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-22 Edition 3.1 2012-10; IEC 60601-2-25 Edition 2.0 2011-10; ANSI/AAMI IEC 60601-2-25:2011/(R)2016; IEC 60601-2-27 Edition 3.0 2011-03; ANSI/AAMI IEC 60601-2-27:2011(R)2016; IEC 60601-2-28 Edition 3.0 2017-0

IEC 60601-1-6Name not checked yet

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IEC 60601-1-8Name not checked yet

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IEC 60601-1-10Name not checked yet

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IEC 60601-1-11Medical 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

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IEC 60601-1-12Name not checked yet

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IEC 60601-2-2Name not checked yet

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IEC 60601-2-10Name not checked yet

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IEC 60601-2-16Name not checked yet

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IEC 60601-2-18Name not checked yet

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IEC 60601-2-19Name not checked yet

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IEC 60601-2-20Name not checked yet

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IEC 60601-2-22Name not checked yet

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IEC 60601-2-25Name not checked yet

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IEC 60601-2-27Name not checked yet

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IEC 60601-2-28Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

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IEC 60601-2-35Name not checked yet

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ISO 80601-2-55; IEC 60601-2-57; IEC 60601-2-63; IEC 60601-2-65; IEC 61010-1; ANSI/UL 61010-1; IEC 80601-2-30; ANSI/AAMI IEC 80601-2-30:2018; IEC 60601-2-35; IEC 80601-2-60; ISO 80601-2-56; ISO 80601-2-61; IEC 80601-2-77; ANSI/AAMI IEC 80601-2-77:2020; ISO 80601-2-12; ISO 80601-2-69; ISO 80601-2-70; ISO 80601-2-72; ISO 80601-2-74; IEC 80601-2-78; ISO 80601-2-79; ISO 80601-2-80; ISO 80601-2-84; ISO 80601-2-87; ISO 7494-1; ISO 7494-2; ISO 10079-1; ISO 10079-2; ISO 10079-3; ISO 10079-4; ISO 80369-1; IEC 80369-5; ANSI/AAMI ISO 80369-5:2016; ISO 9168; ISO 14457; ANSI/ADA Standard No. 35-2019; ISO 3964; ANSI/ADA Standard No. 158-2020

IEC 60601-2-57Name not checked yet

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IEC 60601-2-63Name not checked yet

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IEC 60601-2-65Name not checked yet

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ISO 80601 series

ISO 80601-2-12Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

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ISO 80601-2-13Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

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ISO 80601-2-55Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

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ISO 80601-2-56Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

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ISO 80601-2-61Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

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ISO 80601-2-69Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

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ISO 80601-2-70Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

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ISO 80601-2-72Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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ISO 80601-2-74Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

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ISO 80601-2-79Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

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ISO 80601-2-80Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

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ISO 80601-2-84Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

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ISO 80601-2-87Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators

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ISO

ISO 3964Dentistry - Coupling dimensions for handpiece connectors

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ISO 7494-1Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements

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ISO 7494-2Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems

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ISO 9168Dentistry - Hose connectors for air driven dental handpieces

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ISO 10650Dentistry - Powered polymerization activators

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 11195Gas mixers for medical use - Stand-alone gas mixers

As written on the certificate · Line 12 (A2LA 5162.01)

ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 14457Dentistry - Handpieces and motors

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ISO 80369-1Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

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ISO 80369-5Name not checked yet

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EN

EN 50360Name not checked yet

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EN 50364Name not checked yet

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EN 50383Name not checked yet

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EN 50384Name not checked yet

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EN 50385Name not checked yet

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EN 50401Name not checked yet

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EN 50566Name not checked yet

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EN 50663Generic standard for assessment of low power electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (10 MHz - 300 GHz)

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IEC

IEC 61010-1Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

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IEC 62209-1Name not checked yet

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IEC 62209-2Name not checked yet

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IEC 62311Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz)Certificate says EN 62311. Probably the same standard; not checked against the EN document.

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IEC 62369-1Name not checked yet

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IEC 62479Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz)

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IEC 80369-5Name not checked yet

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CISPR

CISPR 11Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurementCertificate says AS CISPR 11, EN 55011. Probably the same standard; not checked against the EN document.

As written on the certificate · Line 1 (A2LA 5162.01)

FCC 47 CFR Part 15, Subpart B (using ANSI C63.4:2014); FCC 47 CFR Part 18 (using MP-5:1986); AS CISPR 11; AS CISPR 14.1; AS CISPR 15; CISPR 11; CISPR 12; CISPR 14-1; CISPR 15; CISPR 22; CISPR 32; AS/NZS CISPR 15; AS/NZS CISPR 32; EN 55011; EN 55012; EN 55014-1; EN 55015; EN 55032; EN IEC 55014-1; EN IEC 55015; BS EN 55011; BS EN 55012; BS EN 55014-1; BS EN 55015; BS EN 55032; BS EN IEC 55014-1; BS EN IEC 55015; GB 14023; GB 4343.1; GB 4824; GB/T9254.1; ICES-001; ICES-002; ICES-003; ICES-005; J55014-1; J55015; J55011; J55032; SANS 212; SANS 214-1; SANS 215; SANS 2332; AS/NZS 61000.3.2; IEC 61000-3-2; EN 61000-3-2; EN IEC 61000-3-2; BS EN 61000-3-2; BS EN IEC 61000-3-2; EN 61000-3-12; BS EN 61000-3-12; IEC 61000-3-12; GB 17625.1; IEC 61000-3-3; EN 61000-3-3; BS EN 61000-3-11; BS EN 61000-3-3; BS EN IEC 61000-3-11; GB/T 17625.2; IEC 61000-3-11; EN 61000-3-11; EN IEC 61000-3-11

CISPR 12Vehicles, boats and devices with internal combustion engines or traction batteries - Radio disturbance characteristics - Limits and methods of measurement for the protection of off-board receiversCertificate says EN 55012. Probably the same standard; not checked against the EN document.

As written on the certificate · Line 1 (A2LA 5162.01)

CISPR 14-1Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: EmissionCertificate says EN 55014-1, IEC 55014-1. Probably the same standard; not checked against the EN document.

As written on the certificate · Line 1 (A2LA 5162.01)

CISPR 15Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipmentCertificate says EN 55015, IEC 55015. Probably the same standard; not checked against the EN document.

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CISPR 32Electromagnetic compatibility of multimedia equipment - Emission requirementsCertificate says EN 55032. Probably the same standard; not checked against the EN document.

As written on the certificate · Line 1 (A2LA 5162.01)

IEC 61000 series

IEC 61000-3-2Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)

As written on the certificate · Line 1 (A2LA 5162.01)

IEC 61000-3-3Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection

As written on the certificate · Line 1 (A2LA 5162.01)

IEC 61000-3-11Electromagnetic compatibility (EMC) - Part 3-11: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems - Equipment with rated current ≤ 75 A and subject to conditional connection

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IEC 61000-3-12Electromagnetic compatibility (EMC) - Part 3-12: Limits - Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current >16 A and ≤ 75 A per phaseCertificate says EN 61000-3-12. Probably the same standard; not checked against the EN document.

As written on the certificate · Line 1 (A2LA 5162.01)

IEC 80601 series

IEC 80601-2-30Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

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IEC 80601-2-60Name not checked yet

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IEC 80601-2-77Name not checked yet

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IEC 80601-2-78Name not checked yet

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ISO 10079 series

ISO 10079-1Medical suction equipment - Part 1: Electrically powered suction equipment

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ISO 10079-2Medical suction equipment - Part 2: Manually powered suction equipment

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ISO 10079-3Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source

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ISO 10079-4Medical suction equipment - Part 4: General requirements

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ISO 7176 series

ISO 7176-5Wheelchairs - Part 5: Determination of dimensions, mass and manoeuvring space

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 7176-7Wheelchairs - Part 7: Measurement of seating and wheel dimensions

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 7176-9Wheelchairs - Part 9: Climatic tests for electric wheelchairs

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 7176-25Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 8600 series

ISO 8600-1Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements

As written on the certificate · Line 12 (A2LA 5162.01)

ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 8600-3Endoscopes - Medical endoscopes and endotherapy devices - Part 3: Determination of field of view and direction of view of endoscopes with optics

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 8600-4Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

ISO 8600-5Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics

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ISO 10650; ANSI/ADA Standard No. 48; ISO 7176-5; ISO 7176-7; ISO 7176-9; ISO 7176-25; ISO 11195; ISO 8600-1; ISO 8600-3; ISO 8600-4; ISO 8600-5; IEC 60601-1-2; ANSI/AAMI IEC 60601-1-2:2014

Other standards

FCC MP-5:1986Name not checked yet

As written on the certificate · Line 6 (A2LA 5162.01)

FCC MP-5:1986; ANSI C63.10:2020; FCC KDB 905462 D02 (v02); ANSI/TIA-603-E; TIA-102.CAAA-E; ANSI C63.26:2015; IEEE Std 1528:2013

FCC PART 15Radio Frequency Devices

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RSS-102Name not checked yet

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Scope as published by A2LA

13 lines

A2LA

ISO/IEC 17025

Active

5162.01

The scope document we hold says it is valid until 2027-03-31.

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