IEC 60601-1-2 Accredited Testing Labs Worldwide

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 GREEN MOUNTAIN ELECTROMAGNETICS, INC. 219 Blake Roy Road Middlebury, VT 05753 Kyle R. Kowalczyk Phone: 802 388 3390 email: gme@gmelectro.com Website: www.gmelectro.com

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 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSIO

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 MEDTECH TESTING SOLUTION CO., LTD. 9F., No.657-7, Zhongzheng Rd., Xinzhuang Dist., New Taipei City 24243, Taiwan (R.O.C.) Koen Ke Phone: 886-2-2901-6998 ELECTRICAL

T298/M23/2025 Liite 1 / Appendix 1 Sivu / Page 21(23) Vaatimus/Requirement SFS-EN ISO/IEC 17025:2017 17.12.2025 Päätöksen päiväys / Date of decision 22.07.2028 Päätöksen viimeinen voimassaolopäivä / Date of expiry www.finas.fi Voimas

IEC 60601-1-2:2014, modifiziert); Deutsche Fassung EN 60601-1-2:2015 VDE 0750-1-2: 2016-05 DIN EN 60601-1-2 : 2007-12 ⊗ - Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesent

Laboratorio EMC Sitael S.p.A. Via San Sabino 21 70042 Mola di Bari BA Allegato al certificato di accreditamento n. 02190 rev. 1 del 23/01/2025 UNI CEI EN ISO/IEC 17025:2018 Revisione: 3 Sede A Data: 19/12/2025 pag. 1 di 3 ELENC

Test Technology: Test Method(s) 2,3: Immunity Radiated Immunity IEC/EN 61000-4-3; AS/NZS IEC 61000.4.3; BS EN 61000-4-3; GB/T 17626.3 Electrical Fast Transient/Burst IEC/EN 61000-4-4; AS/NZS IEC 61000.4.4; BS EN 61000-4-4; GB/T

SCOPE OF ACCREDITATION TO ISO/IEC 17025:20171 SGS TAIWAN LTD. RELIABILITY LABORATORY 31, Wu Chyuan Road, New Taipei Industrial Park New Taipei City, Taiwan 24886 Winson Tseng Phone: (886) 2-2299-3279 Ext 3620 E-mail: winson.t

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 IEC 60601-2-2 Edition 6.0 2017-03 (clauses 201.17, 202.7, 202.8 only) 6-389 IEC 60601-2-5: Edition 3.0 2009-07 (clause 201.17 only) 12-205 IEC 60601-2-6 Edition 2.1 2016-04 (c

Test(s): Test Method(s) 1,3,4 : Electrical Systems Intended for Use in the Emergency Medical Services Environment Medical Electrical Equipment –Part 2-10: Particular Requirements for the Basic Safety and Essential Performance o

Test Test Method(s) Drop Testing Drop Testing ASTM D5276 Concentrated Impact Testing ASTM D6344 Mechanical Handling of Unitized Loads ASTM D6179 Bridge Impact Testing ASTM D5265 Incline Impact Testing ASTM D880 Horizontal Impac

Test: Test Method(s) 1: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability IEC 60601-1-6; EN 60601-1-6 Medical devices – Part 1: Application

IEC 60601-1-2; EN 61000-6-3 2; KS C 9610-6-3; EN 61000-6-42; KS C 9610-6-4; GB 9254:2008; GB 9254; CNS 15936:2016 Harmonics IEC 61000-3-2:2014 2; IEC 61000-3-2:2018 2; IEC 61000-3-2 2; EN 61000-3-2:2014 2; EN 61000-3-2:2019 2; EN

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 Leistungsmer

IEC 60601-1-2; EN 60601-1-2; KS C IEC 60601-1-2; IEC TS 60601-4-2; EN 60601-2-2 (Section 202 only); EN 60601-2-10 (Section 202 only); EN 60601-2-18 (Section 202 only); EN 60601-2-22 (Section 201.17 only); EN 60601-2-24 (Section 20

IEC 60601-1-2 : 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests + Amendment 1 : 2020-09 IEC 60

Tests (Parameters): Standard(s)1,2: Ultrasonic physiotherapy equipment IEC 60601-2-5; EN 60601-2-5; CAN/CSA-C22.2 No. 60601-2-5 High-voltage generators of diagnostic X-ray generators IEC 60601-2-7; EN 60601-2-7; CAN/CSA-C22.2 No. 6060

Deutsche Fassung EN 60601-2-13:2006 + A1:2007 VDE 0750-2-12 (2007-05)⊗ DIN EN IEC 60601-2-16 : 2020-05 Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkm

Test Technology: Test Method(s) 1, 2: Intentional Radiators (Using ANSI C63.4:2014, ANSI C63.26:2015; ANSI C63.27, and ANSI C63.10:2013 up to 40 GHz; excluding HAC and SAR unless otherwise noted) (cont.) KS X 3124; KS X 3137;

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; EN 50130-4; BS EN 50130-4; ETSI EN 301 489-1; ETSI EN 301 489-3; ETSI EN 301 489-9; ETSI EN 301 489-17; EN IEC 61851-21-2; BS EN IEC 61851-21-2; IEC 61851-21-2 Intentional Radiators (e

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2 Radio Communications Radiated and Conducted (up to 40 GHz)

IEC 60601-1-2 8 kV décharges au contact / 15 kV dans l’air IR3 Matériels électroniques (1) EN / IEC 61000-4-3 EN / IEC 61000-6-1 EN / IEC 61000-6-2 EN / IEC 60601-1-2 10 V/m 80 à 3 GHz 3V/m 3 à 6 GHz IC4 Matériels électroniques (1)

10:2007 + A1:2013); German version EN 60601 -1-10:2008 + A1:2015 DIN EN 60601-1-11 : 2021-12 Medical electrical equi pment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements

IEC 60601-1-8 Paragraphe 6.3.3.2

IEC 60601-1-2; IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; SANS 60601-1-2; ANSI/USEMCSC C63.27; AAMI TIR69; AIM Standard 7351731; IEC 61000-4-39 Marine Device DNVGL-CG-0339 Clause 14; IEC 60533 ITE/Telecom CISPR 24; EN 55024; BS

IEC 60601-1-2:2007 Ed 3.0 A,B,C,E,G,S EN 60601-1-2:2007 A,B,C,E,G,S IEC 60601-1-2:2014 Ed 4 EN 60601-1-2:2015 IEC 60601-1-2 Edition 4.1 (2020/09) EN 60601-1-2:2015 & A1:2021 A,B,C,E,G,S A,B,C,E,G,S A,B,C,E,G,S A,B,C,E,G,S

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 -1-2: 2016 -05 ⊗ - Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich de

IEC 60601-1-2, EN 60601-1-2 UK- Emissions & Immunity BS EN 55011; BS EN 55015 (excluding 9kHz-30MHz); BS EN 55032; BS EN 55035; BS EN IEC 61000-3-2; BS EN IEC 61000-3-3; BS EN IEC 61000-4-2; BS EN IEC 61000-4-3; BS EN IEC 61000-4-4;

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 EUROFINS ELECTRICAL AND ELECTRONIC UK LIMITED (Tradi

IEC 60601-1-2:2014 + A1:2020) 1.20 Generic and Product EN 61000-6-1:2007 B, C, G Standards IEC 61000-6-1:2007 B, C, G EN 61000-6-1:2019 B, C, G These generic and product IEC 61000-6-1:2016 B, C, G specific standard

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 SHENZHEN NTEK TESTING TECHNOLOGY CO., LTD. No. 24 Xinfa East Road Xiangshan Community Xinqiao Street, Baoan District Shenzhen, Guangdong, People’s Republic of China Alex Li Phone: 8

IMQ SpA Via Quintiliano 43 20138 Milano MI UNI CEI EN ISO/IEC 17025:2018 Revisione: 58 Sede A Prova dell'infiammabilità al filo incandescente (GWEPT)/Glow-wire flammability test Prova della fiamma con ago/Needle-flame test Prove di e

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 3C Test Ltd Issue No: 068 Issue date: 22 Aug

IEC 60601-1-2:2014 + A1:2020); Deutsche Fassung EN 60601-1-2:2015 + A1:2021 VDE 0750-1-2:2016-05 DIN EN 60601-1-2 : 2016-05⊗ - Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der we

IEC 60601-1-2 Radio US (FCC) CFR 47 FCC Part 15C (using ANSI C63.10:2013 or ANSI C63.10:2020); CFR 47 FCC Part 15E (using ANSI C63.10:2013 or ANSI C63.10:2020 and KDB 905462 D02 (v02)); CFR 47 FCC Parts 22 (cellular), 24, 25 (be

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; YY 9706.102; CISPR 14-1; EN 55014-1; EN IEC 55014-1; BS EN 55014-1; GB 4343.1; SASO CISPR 14-1;

IEC 60601-1-2; CISPR 35; IEC/EN 55035; BS EN 55035; ETSI EN 301 489-1; ETSI EN 301 489-3; ETSI EN 301 489-9; ETSI EN 301 489-17; ETSI EN 301 489-53 Radio Communications (excluding DFS) 47 CFR, FCC Parts 15 C and E (using ANSI C6

Chirurgiegeräten und HF -chirurgischem Zubehör (IEC 60601 -2- 2:2009); Deutsche Fassung EN 60601-2-2:2009 VDE 0750-2-2:2010-01 ⊗ DIN EN 60601-2-10 : 2017-09 Medizinische elektrische Geräte - Teil 2 -10: Besond ere Festlegungen für die

Test Technology: Test Method(s)2: Electrical Performance (continued) Energy Star ENERGY STAR® Program Requirements Product Specification for Computers, Test Method version 9.0; ENERGY STAR® Program Requirements Product Specifica

UL International Italia Srl Via delle Industrie, 6 20061 Carugate MI Allegato al certificato di accreditamento n. 00999 rev. 6 del 16/07/2025 UNI CEI EN ISO/IEC 17025:2018 Revisione: 27 Sede A Data: 16/07/2025 pag. 6 di 25 No.

Przedmiot badań/wyrób Rodzaj działalności/badane cechy/metoda Dokumenty odniesienia Urządzenia techniki fonicznej/wizyjnej, informatycznej i telekomunikacyjnej Badanie narażenia na światło łuku ksenonowego PN-EN IEC 62368-1:2020-11

Test Technology: Test Method(s)1 : Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances EN 13718-1 Safety requirements for electrical equipment for measurement, co

Test Technology: Test Method(s):1,2,3 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance BS EN 60601-1; IEC 60601-1; ANSI/AAMI ES60601-1:2005/A2:2021 Safety requirements for ele

IEC 60601-1-2; EN 60601-1-2; YY 9706.102; IEC 15194 (excluding Radiated Immunity 20MHz~80MHz); EN 15194 (excluding Radiated Immunity 20MHz~80MHz); EN 12016

Test Technology: Test Capabilities: Test Specifications/Standards: Humidity1 (5 to 95) %RH Telcordia GR-63-CORE; GR-487-CORE; GR-950-CORE; GR-3108-CORE; MIL-STD-810F, G, and H; MIL-STD-810H Method 507.6; MIL-STD-202; RTCA

Test Technology: Test Method(s) 1: Medical electrical equipment − Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; Corrigendum 1 (excluding clause 202

Certification Scheme Product Type / Category Standards / Requirements ITL Certification Scheme Medical Electrical Equipment (MED) (continued) IEC/EN/CAN/SI 60601-2-62; IEC/EN/CAN/SI 60601-2-63; IEC/EN/CAN/SI 60601-2-64; IEC/EN/C

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 PACKAGING COMPLIANCE LABS, LLC 10 Cook Street Suite 3 Billerica MA, 01821 Ryan Ott Phone: (616) 227 - 4540 E-mail: rott@pkgcompliance.com MECHANICAL Valid To: August 31, 2

Test: Test Method(s) 1,2 : Medical (cont.) IEC 60601-1-11; IEC 60601-1-11 Edition 2.1 2020-07 Consolidated Version (The above st