IEC 60601-1-2 Accredited Testing Labs Worldwide

IEC 60601-1-2; TCVN 7317:2003; TCVN 7189:2009; TCVN 7317:2003 EMC for Radio Equipment and Services (Emissions Only, Excluding Harmonics, Flicker and Immunity) ETSI EN 301 489-1; ETSI EN 301 489-3; ETSI EN 301 489-4; ET

Test Technology: Test Method(s) 1: Immunity Electrostatic Discharge (ESD) AS/NZS IEC 61000.4.2; IEC/EN IEC/BS EN IEC 61000-4-2; GB 17626.2; GB/T 18287; GB/T24338.4; IEC/EN/BS EN 61960-3; EN/BS EN50155; EN/BS EN 50121-1; Ele

Test Technology: Test Method(s) 1: Medical (cont.) ANSI AAMI IEC 60601-2-20 Edition 2.1 2016-04 (Section(s) 201.17/202) 1; ANSI AAMI I

Test: Parameters: Test Method(s) 1: Temperature / Humidity (5 to 95) % RH BellCore GR-63-CORE 5.1.1.3 and 5.1.2; IEC 68-2-30, Test Db; MIL-STD-810E, Method 507.3; MIL-STD810F, Method 507.4; MIL-STD-810G, Method 507.5; MIL STD-

Przedmiot badań/wyrób Rodzaj działalności/badane cechy/metoda Dokumenty odniesienia Wymagania bezpieczeństwa dotyczące elektrycznych przyrządów pomiarowych, automatyki i urządzeń laboratoryjnych - Oznakowanie i dokumentacja - Ochr

Deutsche Akkreditierungsstelle DIN EN IEC 60601-2-39 : 2020-05 Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten (IEC 6060

IEC 60601-1-2:2014 + A1:2020); Deutsche Fassung EN 60601-1-2:2015 + A1:2021 VDE 0750-1-2:2022-01 DIN EN 60601-1-11 : 2021-12 Medizinische elektrisc he Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der we

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 19-36 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION 5-132 IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-

IEC 60601-1-2; EN 60601-1-2; SANS 60601-1-2 Radio Tests US/FCC ANSI C63.4; ANSI C63.10:2013; ANSI C63.10:2020; ANSI C63.26; ANSI/TIA-603E; ASTM E2213-03; ANSI/TIA-102.CAAA-E; FCC KDB 905462 D02v02; CFR 47 FCC Part 15 Subpart C; CF

IEC 60601-1-2; BS EN 60601-1-2; IEC 61000-6-1; AS/NZS 61000.6.1(Excluding -20, 21, 22, 34); EN IEC 61000-6-2; BS EN IEC 61000-6-2 (Excluding -20, 21, 22, 34); IEC 61000-6-2; AS/NZS 61000.6.2 (Excluding -20, 21, 22, 34); EN IEC 61000-

IEC 60601-1-2:2014 + A1:2020); Deutsche Fassung EN 60601-1-2:2015 + A1:2021 DIN EN 60601-1-2 : 2016-05 ⊗ - Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungs

DIN EN 60601-2-24 : 2016-04 Medizinische elektrisch e Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Infusionspumpen und Infusions reglern (IEC 60601-2-24:2012); Deutsc

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; SANS 60601-1-2; IEC TS 60601-4-2 ITE/Telecom CISPR 35; EN 55035; BS EN 55035; SANS 2335 Radio Equipment ETSI EN 301 489-1; ETSI EN 301 489-3; ETSI EN 301 489-17; ETSI EN 301 489-5

PRS LAB srl Unipersonale - Sede di Faloppio UNI CEI EN ISO/IEC 17025:2018 Allegato al certificato di accreditamento n. 00983 rev. 8 del 25/06/2025 Via Campagna, 92 22020 Faloppio CO Prove di emissioni/Emissions tests, Prove di immunità/

Test Technology: Test Method(s) 1,2: Product Family and Industry Specific Standards (includes Emissions and Immunity Tests and EN and IEC equivalents) ANSI C62.41; ANSI T1.315:2007; ANSI C63.27:2021; AS

Test Technology: Test Method(s) 1: Immunity (cont.) Conducted Immunity IEC/EN/BS EN 61000-4-6 Power Frequency Magnetic Field IEC/EN/BS EN 61000-4-8 Voltage Dips and Interrupts IEC/EN IEC/BS EN IEC 61000-4-11 Product Family S

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; ANSI/AAMI/IEC 60601-1-2; KS C IEC 60601-1-2

IEC 60601-1-2: 2001 (Withdrawn) IEC 62055-31:2005 (Withdrawn) IEC 62053-23 (2003) (Withdrawn) IEC 60695-2-10(2000) (Withdrawn) IEC 60695-2-11(2000) (Withdrawn) IEC 62059-32-1:2011 IEC 62053-24 (2014) + A1:2016 (Withdrawn) AS 62053.2

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2 (Excluding Proximity testing outlined in table 9)

IEC 60601-1-2:2014 EN 61000-6-1:2001 EN 61000-6-1:2007 EN 61000-6-1:2019 excluding EN 61000-4-34 IEC 61000-6-1:2005 EN 61000-6-2:2001 EN 61000-6-2:2005 EN 61000-6-2:2019 excluding EN 61000-4-34 IEC 61000-6

Test: Test Method(s)1: Temperature/Humidity2 (5 to 95) %RH (continued) MIL-STD-1576 (All); RTCA/DO-160 B, C, D, E, F, G, (Section 6); SAE/USCAR 24 (Inflator Requirements) June 2004; SAE/USCAR 28 (Initiator Requirements) June 2005;

3 Exclusions Table Standard Clause Measurement/testing IEC 60601-1 9.5 Expelled parts Hazard 9.5.2 Cathode ray tubes. 9.7.5 Pressure vessels 11.2.2 ME Equipment and ME systems used in conjunction with. 11.4 ME Equipment and ME System

Test(s): Test Method(s) 1,2: Medical devices - Application of usability engineering to medical devices IEC 62366; EN 62366; IEC 62366-1; EN 62366-1; CSA IEC 62366-1; ANSI/AAMI/IEC 62366-1 Medical electrical equipment - Part 1: Ge

IEC 60601-1-2; IEC/TR 60601-4-2 Edition 1.0 2016-05; IEC TS 60601-4-2 Edition 1.0 2024-03 Automotive EMC Automotive Radiated & Conducted Emissions CISPR 25 (2016, 2021) Section 6.5; CISPR 25 (2016, 2021) Sections 6.3 and 6.4;

Test Technology: Test Method(s)2 Household and Similar Equipment EN 60335-1; EN 60335-2-2; EN 60335-2-3; EN 60335-2-6; EN 60335-2-8; EN 60335-2-9; EN 60335-2-10; EN 60335-2-12; EN 60335-2-13; EN 60335-2-14; EN 60335-2-15; EN 60335-2-1

DEKRA Testing and Certification S.r.l. UNI CEI EN ISO/IEC 17025:2018 Allegato al certificato di accreditamento n. 00152 rev. 7 del 23/01/2025 Via della Fisica 20 36016 Thiene VI Revisione: 50 Sede A Data: 22/01/2026 pag. 6 di 7

The testing laboratory is permitted, without being required to inform and obtain prior approval from DAkkS, to use standards or equivalent testing methods listed here with different issue dates. The testing laboratory maintains a current

ISO/IEC 17025:2017 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pin e Tre e s, Ch e rts ey La n e , Sta ine s -u po n-Tha me s , TW18 3 HR, UK KP Acoustics Research Labs Ltd Issue No: 001

Testing Activities performed under the scope of the U.S FDA ASCA Pilot Program Specifications: Basic Safety and Essential Performance of Medical El ectrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standa

T290/A21/2025 Liite 1 / Appendix 1 Sivu / Page 10(24) Vaatimus/Requirement SFS-EN ISO/IEC 17025:2017 30.10.2025 Päätöksen päiväys / Date of decision 31.12.2029 Päätöksen viimeinen voimassaolopäivä / Date of expiry www.finas.fi Voimassaoleva

ISO/IEC 17025:2017 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pin e Tre e s, Ch e rts ey La n e , Sta ine s -u po n-Tha me s , TW18 3 HR, UK Kiwa Ltd t/a Kiwa Electrical Compliance Issue No:

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; EN 61326-1; EN 61326-2-1; EN 61326-2-2; EN 61326-2-3; EN 61326-2-4; EN 61326-2-5; EN 61326-2-6; EN IEC 61326-1; EN IEC 61326-2-1; EN IEC 61326-2-2; EN IEC 61326-2-3; EN IEC 61326-

(A2LA Certificate No. 3857.01) 11/13/2025 Page 7 of 9 Test Technology: Test Method(s)1,2: FIRA CONSORTIUM (Only UWB RF Power Measurement) FIRA CONSORTIUM UWB MAC TECHNICAL REQUIREMENTS; FiRa USB VCOM Technical Requirements

Przedmiot badań/wyrób Rodzaj działalności/badane cechy/metoda Dokumenty odniesienia Medyczne urządzenia elektryczne Szczeliny w ochronie przed  zagrożeniami mechanicznymi Zakres: (0,1 - 1000) mm Metoda: pomiar wielkości liniowych PN

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION 5-132 IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-131 IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSI

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 ELEMENT MATERIALS TECHNOLOGY – HULL Unit E, South Orbital Trading Park, Hedon Road Kingston upon Hull HU9 1NJ United Kingdom Richard White Phone: +44 (0)1482 800 20 Email: Richard.

IEC 60601-1-2 Laboratory Equipment IEC 61326-1; EN 61326-1

according DIN EN ISO/IEC 17025:2018 Valid from : 03 .05.2024 Date of issue : 09.05.2025 Page 24 of 42 This document is a translation. The definitive version is the original German annex to the accreditation certificate. DIN

Peritoneal Dialysis Equipment IEC 60601-2-39:20181; EN 60601-2-39:2019; GB 9706.239:2021; CSA C22.2 No. 60601-2- 39:2023; Electromyographs and Evoked Response Equipment IEC 60601-2-40:2016; CAN/CSA C22.2 No. 60601-2- 40:2017; E

Nemko S.p.A. a socio unico Via del Carroccio, 4 20853 Biassono MB Allegato al certificato di accreditamento n. 00036 rev. 4 del 23/01/2025 UNI CEI EN ISO/IEC 17025:2018 Revisione: 35 Sede A Data: 15/10/2025 pag. 9 di 40 EN IEC

IEC 60601-1-2; IEC 60601-1-2; ETSI EN 300 386; 47 CFR FCC Part 15B (using ANSI C63.4:2014); 47 CFR FCC 18 (using FCC MP- 5:1986); ICES-001; ICES-003; ICES-005; EN IEC 62040-2:2018; IEC 62040-2; IEC 62920; EN 62920; EN IEC 6105

IEC 60601-1-2:2014; EN 61000-6-1:2019; EN 61000-6-2:2019; EN 61000-6-3:2021; EN 61000-6-4:2019; EN 61326-1:2020; RESNA WC-2:2009 (Section 21); ETSI EN 301 489-1 V2.2.3; ETSI EN 301 489-3 V2.1.1; ETSI EN 301 489-17 V3.2.4; ETSI EN 3

IEC 60601-1-2:2014; IEC 60601-1-2:2014+A1:2020; EN 60601-1-2:2015; EN 60601-1-2:2015+A1:2021; ANSI/AAMI/IEC 60601-1-2:2014; ANSI/AAMI/IEC 60601-1-2:2014+A1:2021; IEC 60601-1-2; EN 60601-1-2; ANSI/AAMI/IEC 60601-1-2 Electrical equipm

Test Technology: Test Method(s): Medical Endoscopes (continued) Photography — Electronic still-picture imaging — Noise measurements ISO 15739 3rd Edition (2017-05) Photography — Electronic still picture imaging — Resolution

IEC 60601-1-2; KS C 9814-1:2020; KS C 9990; KS C 9814-2; KS X 3126; KS X 3128; KS X 3131; KS X 3127; KS X 3130; KS X 3135; KS X 3132; KS X 3136 ; KS X 3137; KS X 3134; KS X 3138; KS X 3139; KS C 9040-2; KS X 3129:2020; K

ISO/IEC 17025:2017 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pin e Tre e s, Ch e rts ey La n e , Sta ine s -u po n-Tha me s , TW18 3 HR, UK dB Technology (Cambridge) Limited Issue No: 010

Department Standard / in house procedure / Version Title of standard or in-house procedure (deviations / modifications of standard) Test area / reductions Medical Equipment # DIN EN 60601 -2-37:2016 VDE 0750-2-37:2016 Medica

IEC 60601-1-2; EN 60601-1-2; EN 301 489-1; EN 301 489-3; EN 301 489-5; EN 301 489-9; EN 301 489-13; EN 301 489-15; EN 301 489-17; EN 301 489-19; EN 301 489-34; EN 301 489-50; EN 301 489-52 (Excluding Audio Breakthrough) Radio

IEC 60601-1-2 EN / IEC 61000-6-1 EN / IEC 61000-6-2 EN / IEC 61000-6-3 EN / IEC 61000-6-4 EN / IEC 61000-6-5 EN / IEC 61000-6-7 EN / IEC 61000-6-8 EN / IEC 61131-2 EN / IEC 61204-3 EN / IEC 61326-1 EN / IEC 61326-2-X EN

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 WALTEK TESTING GROUP CO., LTD. No. 77, Houjie Section, Guantai Rd., Houjie Town Dongguan City, Guangdong, 523900, People’s Republic of China Ms. Joy Zhou Phone: 86-0769-22676998