IEC 60601-1-11 Accredited Testing Labs Worldwide

IEC 60601-1-11; IEC 60601-2-2; IEC 60601-2-10; IEC 60601-2-18; IEC 60601-2-22; IEC 60601-2-28 2; IEC 60601-2-36; IEC 60601-2-37; IEC 60601-2-43 2; IEC 60601-2-44 2; IEC 60601-2-45 2; IEC 60601-2-54 2; IEC 60601-2-57; IEC 8060

IEC 60601-1-11; IEC 60601-1-11 Edition 2.0 2015-01; IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION; ANSI AAMI HA60601-1-11; ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021]; CSA C22.2 No. 60601-1-11; EN 60601-1-11 IEC 6060

IEC 60601-1-11; IEC 60601-1-12; IEC 60601-1-3; IEC 60601-1-4; IEC 60601-1-8; IEC 60601-2-10; IEC 60601-2-18; IEC 60601-2-2; IEC 60601-2-23; IEC 60601-2-25; IEC 60601-2-26; IEC 60601-2-27; IEC 60601-2-30; IEC 60601-2-32; IEC 60

IEC 60601-1-11; EN 60601-1-11; ANSI/AAMI HA60601-1-11; CAN/CSA-C22.2 No. 60601-1-11; IEC 60601-1-12; EN 60601-1-12; ANSI/AAMI/IEC 60601-1-12; CAN/CSA-C22.2 No. 60601-1-12; EN 1789; IEC 62304; EN 62304; ISO 20417; EN ISO 20417; ISO 8

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1-11:2015 + A1:2021 VDE 0750-1-11:2021-12 DIN EN 60601-1-11:2016-04⊗ Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der we

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1- 11:2015 + A1:2021 DIN EN 60601-1-11 : 2016-04 - Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmer

Department Standard / in house procedure / Version Title of standard or in house procedure (deviaBons /reducBons modificaBons of standard) LocaBon/ reducBons Product Safety IEC 60601 -1-11:2015 IEC 60601-1- 11:2015/A1:2020

Test Technology: Test Method(s) 2,3: Medical Equipment (cont.) ISO 80601-2-84 (Cl 201.17, 202); ISO 80601-2-85 (Cl 201.11.6.5, 201.15.3.5.1

IEC 60601-1-11 Section 4.2 Environmental; IEC 60601-1-12 Section 4.2.2 Environmental Vibration* (Including Environmental Vibration) SAE/USCAR-2; GMW3172; GMW3431; MIL-STD-810, Method 514; IEC 60601-1-11 Section 10; IEC 60068-2-

This document is a translation. The definitive version is the original German annex to the accreditation certificate. Geräten und in medizinischen elektrischen Systemen (IEC 60601-1- 8:2006 + A1:2012); Deutsche Fassung EN 60601 -1-8:2007

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION; ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021]; IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION; ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021]; IEC 60601-2-2 Edi

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1- 11:2015 + A1:2021 VDE 0750-1-11:2021-12 DIN EN 60601-1-11 : 2016-04 ⊗ - Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich

Tests: Standard(s) 2: Laboratory / Process Control / Test Equipment Products (excluding UV Radiation, Flammable Liquids, Cathode ray tubes test) (continued) UL 61010-2-040:2021, Ed. 3; UL 61010-2-051:2015, Ed. 3; UL 61010-2-051:

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-64:2014-09 12-318 IEC 60601-2-68 Edition 1.0 2014-09 12-319 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION 19-34

Test Technology: Test Method(s) 2,3,4: Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical ele

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION 19-39 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-10 Edition 2.1 20

IEC 60601-1-11; EN 60601-1-11; BS EN 60601-1-11; ANSI/AAMI HA 60601-1-11; CAN/CSA C22.2 No. 60601-1-11

T298/M23/2025 Liite 1 / Appendix 1 Sivu / Page 14(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 60601-1-11, section 10.1, IEC 61850-3,

IEC 60601-1-11; EN 60601-1-11; ANSI AAMI HA60601-1-11; CSA C22.2 No. 60601-1-11 Medical Electrical Equipment –Part 1-12: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for Medica

IEC 60601-1-11 (Section 4.2.2 & 4.2.3) High Temperature MIL-STD-810 501.7 Low Temperature MIL-STD-810 502.7 Temperature Shock MIL-STD-810 503.7 Humidity Testing MIL-STD-810 507.6; IEC 61730-2 (Clause 52), IEC 62108 (Clause 10.8), T

IEC 60601-1-11; EN 60601-1-11; ANSI AAMI HA60601-1-11 Medical electrical equipment - Part 2-10: Basic safety and basic performance of nerve and muscle stimulators IEC 60601-2-10; EN 60601-2-10 Medical electrical equipment - Part

IEC 60601-1-11; EN 60601-1-11; ANSI/AAMI HA60601-1-11; CAN/CSA-C22.2 No. 60601-1-11 Emergency medical services environment IEC 60601-1-12; EN 60601-1-12; ANSI/AAMI/IEC 60601-1-12; CAN/CSA-C22.2 No. 60601-1-12 High frequency surgi

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1- 11:2015 + A1:2021 DIN EN 60601-1-11 : 2016-040 - Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistun

IEC 60601-1-11:2010); German version EN 60601-1-11:2010 VDE 0750-1-11:2011-03 ⊗ DIN EN 60601-1-12 : 2022-02 Medical electrical equi pment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standar

IEC 60601-1-11:2015 IEC 60601-1-11:2015 + AMD1:2020 F Excluding: 4.2.3.1: Pressure Testing 12: EMC Testing 13: Acoustic Alarms testing Only Clause 8.3 (ingress protection) B Only Clause 13 (Acoustic ala

IEC 60601-1-11: 2015 C, G and medical electrical +A1; 2020 systems used in the home EN 60601-1-11: 2015 +A1:2021 healthcare environment Exclusions: 4.2.3.1 Pressure testing 8.3.1 Ingress protection IPX1/IPX2

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

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1- 11:2015 + A1:2021 VDE 0750-1-11:2021-12 DIN EN 60601-1-11 : 2016-04 ⊗ - Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherh eit einschließlich

IEC 60601-1-11; EN 60601-1-11; ANSI/AAMI HA60601-1-11; CAN/CSA-C22.2 No. 60601-1-11; IEC 60601-1-12; EN 60601-1-12; ANSI/AAMI/IEC 60601-1-12; CAN/CSA-C22.2 No. 60601-1-12; IEC 60601-2-10; EN 60601-2-10; CAN/CSA-C22.2 No.60601-2-1

IEC 60601-1-11; EN 60601-1-11; ANSI/AAMI HA60601-1-11; CAN/CSA-C22.2 No. 60601-1-11 Medical electrical Equipment -- Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for m

IEC 60601-1-11 Medical device software - Software life cycle processes Medical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability IEC 62304:2006 IEC 60601-1-

IEC 60601-1-11 Sect 4.2.2, 4.2.3; ST/SG/AC.10/11Rev.5 Sect. UN 38.3 T1 Ingress Protection Protection against hazardous parts, foreign objects and dust Test Rod/Wire Probes, Test Sphere Probe, and Test Finger Probe; Dust chamber I

IEC 60601-1-11; EN 60601-1-11; DIN EN 60601-1-11; VDE 0750-1-11; IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION; ANSI AAMI HA60601-1-11:2015 Medical electrical equipment – Part 1-12: General requirements for basic safe

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 60601-1-11; IEC 60601-1-11 Edition 2.1 2020-07 Consolidated Version (The above standards exclude Clauses 10.1.2 Requirements for mechanical strength for non-TRANSIT-OPERABLE MEE and 10.1.3 Requirements for mechanical s

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

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1-11:2015 + A1:2021 DIN EN 60601-1-11 : 2016-040- Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerk

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1-11:2015 + A1:2021 VDE 0750-1-11:2021-12 DIN EN 60601-1-12 : 2022-02 Medizinische elektrische Geräte – Teil 1-12: Allgemeine Festlegungen für die Sicherheit einschließlich der w

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED 19-38 HA60601-1-11:2015 [Including AMD1:2021] 19-47 ANSI AAMI IEC 60601-2-2:2017 6-389 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-6 Editi

IEC 60601-1-11:2015 + A1:2020); Deutsche Fassung EN 60601-1-11:2015 + A1:2021 DIN EN 60601-1-11 : 2016-04 ⊗ - Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistu

IEC 60601-1-11; TSC-3000G Explosive/Rapid Decompression MIL-STD-810 Base, A, B, C, D, E, F, G, H, (Method 500); RTCA/DO-160 B, C, D, E, F, G, (Section 4) Positive Pressure (Over Pressure)2 Up to 30,000 psi MIL-STD-1540 B, C, D, (Sec

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

IEC 60601-1-11; EN 60601-1-11; ANSI/AAMI HA60601-1-11; CAN/CSA-C22.2 No. 60601-1-11 Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipme

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 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION; IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION; CSA CAN/CSA-C22.2 No. 60601-1-6:11 - Medical electrical equipment — Part 1-6: Edition 3.2; IEC 62366-1:2020 1.1 Edition; I

IEC 60601-1-11:2015 + A1:2020); German version EN 60601-1-11:2015 + A1:2021 DIN EN 60601-1-11 : 2016-04 ⊗ - Medical electrical equipment - Part 1-11: Particular requirements for basic safety and essential performance - Collateral stand

IEC 60601-1-11; IEC 60601-1-11:2015 + A1:20201; ANSI AAMI HA60601-1-11; ANSI/AAMI HA 60601-1- 11:2015 + AMD1:20211; CAN/CSA C22.2 No. 60601-1- 11; EN 60601-1-11; NBR IEC 60601-1-11; Medical Electrical Equipment and Medic

IEC 60601-1-11 Edition 2.1 2020-07 General requirements for basic safety and essential performance- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical