ISO 80601-2-61 Accredited Testing Labs Worldwide

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02); IEC 60601-2-68 Edition 1.0 2014-09; IEC 60601-2-68 Edition 2.0 2025-02; ISO 80601-2-69 Second edition 2020-11; ISO 80601-2-70 Second edition 2020-11; ISO 80601-2-74 Fir

Test: Test Method(s)1: EMC – Medical Equipment (continued) EN 60601-2-18 (clause 202 only); IEC 60601-2-21; EN IEC 60601-2-21; JIS T 0601-2-21 (clause 202 only); IEC 60601-2-22; EN IEC 60601-2-22; JIS T 0601-2-22 (clause 202 onl

ISO 80601-2-61 (2017), clause 202; ISO 80601-2-61 (2011), clause 202; ISO 9919 Ed. 2.0 (2005), clause 36; ISO 14117 (2012) sections 4 and 5; ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; ISO 14708-4 (2008-11-15) claus

ISO 80601-2-61 (2017), clause 202; IEC 80601-2-58:2024; IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30, clause 202; ISO 80601-2-61 (2011), clause 202; IEC 60601-2-62:2013, clause 202; ISO 9919 Ed. 2.0 (2005), clause 36; I

DIN EN 61326-2-6:2022-11 Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV- Anforderungen - Teil 2-6: Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD) (IEC 61326-2- 6:2020); Deutsche Fassung EN 61326-2-6:2021 V

ISO 80601-2-61; EN 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; ANSI/AAMI/IEC 80601-2-77:2020; CAN/CSA-C22.2 No. 80601-2-77:19; IEC 60601-2-5:2009; EN 60601-2-5:2015; CSA C22.

ISO 80601-2-61 : 2019-09 Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2- 61:2017, korrigierte Fassung 2018-02);

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

ISO 80601-2-61 Annex EE; SOP Q001; SOP Q002; SOP Q003; SOP Q004; SOP Q008; SOP I001; SOP Q006; SOP Q014 Heart Rate Monitor Device Validation SOP Q001; SOP Q002; SOP Q003; SOP Q004; SOP Q008; SOP Q006 Consumer Product and Consume

ISO 80601-2-61 (Excluding Cl 201.17, 202); EN ISO 80601-2-67 (Excluding Cl 201.17, 202); EN ISO 80601-2-69 (Excluding Cl 201.17, 202)

This document is a translation. The definitive version is the original German annex to the accreditation certificate. DIN EN IEC 80601-2-26:2022-04 Medizinische elektrische Geräte - Teil 2 -26: Besondere Festlegungen für die Sicherheit

Test Technology: Test Method(s) 1,2: (Excluding: ionizing radiation, high vacuum devices, flammability/fire tests, softening temperature, vibration, implosion, dust, microbiological test for bioseals, & ultrasonic pressure)

DIN EN ISO 80601-2-56 : 2018-02 ⊗ - Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur

ISO 80601-2-61 (Ed. 1, Ed. 2); ISO 80601-2-67 (Ed. 2); ISO 80601-2-69 (Ed. 2); IEC 62366; IEC 62366-1; IEC 62304 (Ed. 1 + Am 1) Laboratory (excluding Vicat Softening and CRT/High Vacuum) IEC 61010-1, Ed. 2.0; EN 61010-1, Ed. 2.0;

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment ISO/EN ISO 80601-2-69; CSA C22.2 NO. 80601-2-69 Part

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 MEGALAB GROUP INC. 150 Addison Hall Circle Aurora, ON Canada L4G 3X8 Dr. Oscar Jia, P.Eng. Phone: 905-752-1925 ELECTRICAL Valid To: April 30, 2027 Certificate Number:

ISO 80601-2-61 Second Edition 2017-12 (Corrected Version 2018-02) 1-139 ISO 80601-2-69 Second edition 2020-11 1-148 ISO 80601-2-70 Second edition 2020-11 1-151 ISO 80601-2-72 First edition 2015-04-11 1-105 ISO 80601-2-74 First edition 2

ISO 80601-2-61; EN ISO 80601-2-61; BS EN ISO 80601-2-61; CAN/CSA C22.2 No. 80601-2-61; JIS T 80601-2-61 Nebulizing Systems ISO 27427; EN ISO 27427; BS EN ISO 27427; CAN/CSA ISO 27427; EN 13544-1; BS EN 13544-1 Blood-glucose m

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1; EN 60601-1; ANSI/AAMI ES60601-1; CAN/CSA-C22.2 NO.

ISO 80601-2-61; EN ISO 80601-2-61 Medical electrical equipment -- Part 2-56: Particular requirements for the basic safety and essential performance of colinical thermometers for body temperature measurement ISO 80601-2-56; EN ISO

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Pulse oximeter equipment IEC 80601-2-77; ANSI/AAMI 80601-2-77; CSA C22.2 No. 80601-2-77; EN 80601-2-77 Robotically assisted surgical equipment IEC 80601-2-78; AN

DIN EN ISO 80601-2-56 : 2020-08 Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO

ISO 80601-2-61 : 2019-09 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 806

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 Element Materials Technology Warwick Ltd Issue No:

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

Test Technology: Test Method(s)1 : Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV EN 60601-2-8; IEC

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

Test Technology: Test Method(s) 1: Medical electrical equipment − Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation 3 ISO 80601-2-13; EN ISO 80601-2-13; DIN EN ISO 806

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

ISO 80601-2-61; ISO 80601-2-61 Edition 2.0 2017-12 (Corrected Version 2018-02); IEC 80601-2-77; IEC 80601-2-77 Edition 1.0 2019-07; IEC 80601-2-77 Edition 1.1 2023-11 Consolidated Version; IEC 62304; IEC 62366; IEC 62366-1;

ISO 80601-2-61 Second Edition 2017-12 1 (Corrected version 2018-02) (Section(s) 201.17/202) 1; ISO 80601-2-69 Second Edition 2020-11 (Section(s) 201.17/202) 1; ISO 80601-2-70 Second edition 2020-11; (Section(s) 201.17/202) 1; ISO 80601

ISO 80601-2-61 3; IEC 80601-2-77 Lighting IEC 60598-1:2003; IEC / EN 60598-1; IEC 60598-1:2003/AMD1:2006; IEC 60598-1:2008; IEC 60598-1:2014; IEC 60598-1:2014/AMD1:2017; IEC / EN 60598-2-1

Product Safety Standard 1,2: Title: ISO 80601-2-12 Medical electrical equipment – Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators IEC/EN 60601-2-16 Medical electrical equi

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61

ISO 80601-2-61:2017 DIN EN 80601-2-61:2019 Medical electrical equipment - Part 2 -61: Particular requirements for basic safety and essential performance of pulse oximeter equipment MED IEC 61010 -2-040:2015 ILNAS EN 61010-2-040:2

ISO 80601-2-61 Second Edition 2017-12 (Corrected Version 2018-02) 1-139

according DIN EN ISO/IEC 17025:2018 Valid from : 03.05.2024 Date of issue : 09.05.2025 Page 33 of 42 This document is a translation. The definitive version is the original German annex to the accreditation certificate. DIN E

ISO 80601-2-61:20171 (Corrected 2018); EN ISO 80601-2-61:2019; IEC 60601-1, Edition 3.2 Series Test Technology: Test Method(s) 2, 3, 4: National / Regional Variation(s) 2, 3, 4: Medical Electrical Equipment– Part 1: General

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 -2-54:2016 VDE 0750-2-54:2016 Medica

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-

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

ISO 80601-2-61:2011 (Excluding Sections 201.12.1.101, 201.15.3.5.101); JIS T 80601-2-61:2014 (Excluding Sections 201.12.1.101, 201.15.3.5.101); ISO 80601-2-61:2017 (Excluding Sections 201.12.1.101, 201.15.3.5.101); CSA-C22.2 No. 8060

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 – Standard

ISO 80601-2-61, Clause 202 of EN ISO 80601-2-61, Clause 202 of ISO 80601-2-69, Clause 202 of EN ISO 80601-2-69, Clause 202 of ISO 80601-2-70, Clause 202 of EN ISO 80601-2-70, Clause 202 of ISO 80601-2-74, Clause 202 of EN ISO 806