IEC 60601-2-24 Accredited Testing Labs Worldwide

IEC 60601-2-24; EN 60601-2-24; JIS T 0601-2-24 (clause 202 only); IEC 60601-2-25; EN 60601-2-25; JIS T 0601-2-25; ANSI AAMI IEC 60601-2-25 (clause 202 only); IEC 60601-2-27; EN 60601-2-27; ANSI AAMI IEC 60601-2-27 (clause 202 only);

IEC 60601-2-24:2012); Deutsche Fassung EN 60601-2-24:2015 VDE 0750-2-24:2016-04 DIN EN 60601-2-25 : 2016-08 Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungs

IEC 60601-2-24; EN 60601-2-24; CSA C22.2 NO. 60601-2-24 Defibrillators: IEC 60601-2-4; EN 60601-2-4; CSA-C22.2 NO. 60601-2-4 Endoscope Equipment: IEC 60601-2-18; EN 60601-2-18; CSA C22.2 NO. 60601-2-18 IVD (In Vitro Diagnostic Me

IEC 60601-2-24:2012-10 Medical electrical equipment - Part 2-24: Particular requirements for the safety and essential performance of infusion pumps and controllers IEC 60601-2-25:2011-10 Medical electrical equipment - Part 2-25: Particul

IEC 60601-2-24; EN 60601-2-24; IEC 60601-2-30; EN 60601-2-30; IEC 60601-2-57 Edition 1.0 2011-01; IEC 60601-2-57; EN 60601-2-57; CAN/CSA-C22.2 No. 60601-2-57, (excluding 201.6.1.102, 201.10.103, 201.13.1.101); IEC 60601-2-62:2013; E

Department Standard / in house procedure / Version Title of standard or in house procedure (deviaBons /reducBons modificaBons of standard) LocaBon/ reducBons Product Safety IEC 60601 -2-10:2012 + A1:2016 IEC 60601-2- 10:201

IEC 60601-2-24 (Excluding Cl 201.11.6.3, 201.11.6.5, 201.17, 202); IEC 60601-2-25 (Excluding Cl 201.17, 202); IEC 60601-2-26 (Excluding Cl 201.17, 202); IEC 60601-2-27 (Excluding Cl 201.17, 202); IEC 60601-2-286 (Excluding Cl 201.17

IEC 60601-2-24:2012); Deutsche Fassung EN 60601-2-24:2015

IEC 60601-2-24; EN 60601-2-24; CSA C22.2 NO. 60601-2-24 Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC

Test: Test Method(s) 1: Generic and Product Family Standards (cont.) IEC 62236-4; EN 50155; EN 55013; KN 13; EN 55020 (only for audio/video equipment without tuner); KN 20 (only for audio/video equipment without tuner); EN 50

IEC 60601-2-24:2012); Deutsche Fassung EN 60601-2-24:2015 DIN EN 60601-2-24 : 1999-02⊗ - Medizinische elektrische Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit von Infusionspumpen und Infusionsreglern (IEC 60601-2-24:1998

IEC 60601-2-24: 2012 F Excluding: - 208 (alarm noise level measurement) Only Clause 201.11 (ingress protection) B Only Clause 208 (alarm noise level measurement) G Safety and essential perform

IEC 60601-2-24; EN 60601-2-24; CAN/CSA-C22.2 No. 60601-2-24; IEC 60601-2-25; EN 60601-2-25; ANSI/AAMI 60601-2-25; CAN/CSA C22.2 No. 60601-2-25; IEC 80601-2-26; EN 80601-2-26; CAN/CSA C22.2 No. 80601-2-26; IEC 60601-2-27; EN

IEC 60601-2-24; EN 60601-2-24; CAN/CSA-C22.2 No. 60601-2-24

IEC 60601-2-24; EN 60601-2-24; DIN EN 60601-2-24; VDE 0750-2-24 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs IEC 60601-2-25; EN 60601-2-25

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

IEC 60601-2-24:2012); Deutsche Fassung EN 60601-2-24:2015 Gültig ab: 14.12.2023 Ausstellungsdatum: 14.12.2023 Seite 10 von 18

IEC 60601-2-24 (Infusion Pumps and Controllers); EN/IEC 60601-2-25 (Electrocardiographs); EN/IEC 60601-2-26 (Electroencephalographs); EN/IEC 60601-2-27 (Electrocardiographic Monitoring Equipment); EN/IEC 60601-2-28 (X-ray Tube Assembly

IEC 60601-2-24:2012); Deutsche Fassung EN 60601-2-24:2015 DIN EN 60601-2-37 : 2016-11 Medizinische elektrisch e Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultrascha

IEC 60601-2-24; EN 60601-2-47; EN 60669-2-1; IEC 60669-2-1; EN 60945; IEC 60945; EN 61000-6-1; IEC 61000-6-1; SANS 61000-6-1; EN 61000-6-2; IEC 61000-6-2; SANS 61000-6-2; EN 61000-6-3; IEC 61000-6-3; SANS 61000-6-3; EN 61000-6-4; I

Test Technology: Test Method(s) 1, 4: Product Safety Measurement Equipment2, 3 IEC/EN/KS C IEC/UL 61010-1; CAN/CSA C22.2 No. 61010-1; IEC/EN 61010-2-010; IEC/EN 61010-2-020; IEC/EN 61010-2-040; IEC/EN 61010-2-051; IEC/EN 61010-2-08

IEC 60601-2-24:2012

IEC 60601-2-24:2012); German version EN 60601-2-24:2015 DIN EN 60601-2-25 : 2016-08 Medical electrical equi pment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (IEC 60601-2-25

IEC 60601-2-24; Electroencephalographs IEC 80601-2-26; Automated Non-Invasive Sphygmomanometers IEC 80601-2-30; Heating Devices Using Blankets, Pads, and Mattresses (excluding: Ed.1 Clause 59.2.101 [Spark Ignition Tes

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 -2-22:2015 VDE 0750-2-22:2015 Medica

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

Test Technology: Test Method(s) 2: Hong Kong HKCA 1002; HKCA 1003; HKCA 1007; HKCA 1008; HKCA 1033; HKCA 1035; HKCA 1039; HKCA 1042; HKCA 1043; HKCA 1048; HKCA 1049; HKCA 1052; HKCA 1057; HKCA 1061 Singapore IMDA TS LMR Issue 1, 1 O

IEC 60601-2-24, Clause 202 of EN 60601-2-24, Clause 202 of IEC 60601-2-25, Clause 202 of EN 60601-2-25, Clause 202 of IEC 60601-2-27, Clause 202 of EN 60601-2-27, Clause 202 of IEC 80601-2-30, Clause 202 of EN IEC 80601-2-30,