IEC 60601-1-2 Accredited Testing Labs Worldwide

Test Technology: Test Method(s): Product Safety (Cont’d) AS/NZS 60669.1 (excluding: 22.5, 25); IEC/EN 60669-2-1 (excluding: 22.5, 25); BS

White Lab S.r.l. - Test'ing Via del Consorzio, 41 60015 Falconara Marittima AN Allegato al certificato di accreditamento n. 01044 rev. 7 del 21/05/2025 UNI CEI EN ISO/IEC 17025:2018 Revisione: 25 Sede A Data: 21/05/2025 pag. 2 d

Tests (Parameters): Standard(s)1,2: Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment IEC 60601-2-27; ANSI/AAMI/IEC 60601-2-

DIN EN 60601-1-11 : 2021-12 Medizinische elektrisch e Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und

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, U K Intertek Testing & Certification Ltd Issue No: 14

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

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED Version; ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]; ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] On the Following Types of Products: Base Stations, Subscriber Station

Test(s): Test Method(s)1,2: Medical Equipment4 (Cont’d) ANSI/AAMI ES 60601-1:2005® 2012(Excluding Sections 8.8.4.2, 8.9.1.7, 9.5.2, 9.6.3,

Test(s): Test Method(s): Environmental Simulation: Humidity MIL-STD-202 (Method 103B), MIL-STD-810 (Method 507) Fluorescent UV- Condensation, Light- and Water-Exposure (QUV) ASTM G154 Salt Spray (Fog) ASTM B117; MIL-STD-202

IEC 60601-1-2; IEC 60601-1-2:2014; IEC 60601-1-2:2014+A1:2020; JIS T 0601-1-2:2018; JIS T 0601-1-2:2023 Alarm systems - Part 4: Electromagnetic compatibility - Product family standard: Immunity requirements for components of fire,

Normative document: EN ISO/IEC 17025:2017 Registration number: L 015 of Kiwa Nederland B.V. Kiwa FSS Testing This annex is valid from: 29-01-2026 to 01-09-2028 Replaces annex dated: 28-01-2026 Dutch Accreditation Council RvA

IEC 60601-1-2:2014 + A1:2020); Deutsche Fassung EN 60601-1-2:2015 + A1:2021 DIN EN 60601 -2-18 2016-10 Medizinische elektrische Geräte - Teil 2 -18: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistung

IEC 60601-1-2; IEC 61326-1-2; IEC 61326-2-6; CISPR 35; ETSI EN 301 489-50; ETSI EN 301 489-1 On the following products and materials: Information Technology Equipment (ITE), Multimedia Equipment, Radio Equipment, Household Applian

Tests: Test Method(s) 1: Immunity Electrostatic Discharge (ESD) IEC/EN 61000-4-2; KS C 9610-4-2; RTCA/DO-1602 D, E, F, & G (Section 25); MIL-STD-1686; MIL-STD-461G (CS118) Radiated Immunity IEC/EN 61000-4-3; KS C 9610-4-3; RT

IEC 60601-1-2:2001; IEC 60601-1-2:2007; IEC 60601-1-2 Information Technology Equipment CISPR 24; EN 55024 (Excluding Annex A, CISPR 20) Household Appliances and Similar CISPR 14-2; EN 55014-2 (Excluding IEC 61000- 4-22) Industr

TUV Rheinland Italia S.r.l. Via Mattei 3 20005 Pogliano Milanese MI Allegato al certificato di accreditamento n. 00321 rev. 5 del 25/06/2025 UNI CEI EN ISO/IEC 17025:2018 Revisione: 72 Sede A Data: 29/09/2025 pag. 9 di 64 Appar

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; KS C IEC 60601-1-2; IEC 61000-6-1; EN 61000-6-1; KS C 9610-6-1; IEC 61000-6-2; EN 61000-6-2; KS C 9610-6-2 Radio Intentional Radiators FCC CFR 47, Part 15 Subparts C, E, F, G, and H (using ANSI C63.1

IEC 60601-1-2; EN 60601-1-2 Harmonic Current Emissions EN 61000-3-2; IEC 61000-3-2; KS C 9610-3-2; CNS 14934-2 Voltage Fluctuations and Flicker EN 61000-3-3; IEC 61000-3-3; KS C 9610-3-2; CNS 14934-3 Generic and Pro

Test Technology: Test Method(s): U, Mechanical strength of CRTs and protection against the effects of implosion; Y.2 Resistance to UV radiation; Cl. Y.3 Resistance to corrosion ) Products Incorporating Button Batteries or Coin