Säkerhet och väsentlig prestanda för medicintekniska produkter
IEC 60601-serien är en internationellt erkänd standard för säkerhet och väsentlig prestanda hos medicintekniska produkter.
Den fastställer krav för konstruktion, design och provning av medicintekniska produkter för att säkerställa säker användning för både patienter och vårdpersonal. Serien omfattar flera viktiga delstandarder, där IEC 60601-1 utgör grundstandarden, IEC 60601-1-XX de så kallade kollaterala standarderna och IEC 60601-2-XX de särskilda produktstandarderna.
- IEC 60601-1 (grundstandard): Anger generella krav på säkerhet och prestanda för alla medicintekniska produkter och säkerställer att produkterna fungerar korrekt och är säkra för patientanvändning.
- IEC 60601-1-XX (kollagerala standarder): Kompletterande standarder som behandlar specifika aspekter såsom elektromagnetisk kompatibilitet (EMC), användbarhet och larmsystem.
- IEC 60601-2-XX (produktstandarder): Standarder som gäller specifika typer av medicintekniska produkter och adresserar särskilda säkerhetskrav.
IEC 60601-1
IEC 60601-1 är den grundläggande standarden för säkerhet och väsentlig prestanda hos medicintekniska produkter. Den fastställer grundkrav för att säkerställa att utrustningen inte utgör risk för patienter, användare eller miljö, vare sig vid normal användning eller under felaktiga förhållanden.
Standarden omfattar bland annat:
- mekaniska risker
- elektriska risker
- krav på utrustningens funktion och prestanda
| GENERAL STANDARD | ||
| IEC 60601-1 | IEC 60601-1:2005 + AMD1:2012 - 5 - + AMD2:2020 | IEC 60601-1 Edition 3.2 2020-08 "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance" |
Kollagerala standarder (IEC 60601-1-XX)
IEC 60601-1-XX-standarderna kallas kollaterala standarder och innehåller ytterligare krav som inte omfattas av grundstandarden. De behandlar specifika aspekter av säkerhet och prestanda och används tillsammans med IEC 60601-1.
| EXEMPEL PÅ KOLLAGERALA STANDARDER | ||
| IEC 60601-1-2 | IEC 60601-1-2:2014/ AMD1:2020 | IEC 60601-1-2 Edition 4.0 2020-09 AMENDMENT 1 "Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests" |
| IEC 60601-1-3 | IEC 60601-1-3:2008+AMD1:2013 +AMD2:2021 |
IEC 60601-1-3 Edition 2.2 2021-01 "Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment" |
| IEC 60601-1-6 | IEC 60601-1-6:2010+AMD1:2013 +AMD2:2020 |
IEC 60601-1-6 Edition 3.2 2020-07 "Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability" |
| IEC 60601-1-8 | IEC 60601-1-8:2006+AMD1:2012 +AMD2:2020 |
IEC 60601-1-8 Edition 2.2 2020-07 "Medical electrical equipment – Part 1-8: 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 systems" |
| IEC 60601-1-9 | IEC 60601-1-9:2007+AMD1:2013 +AMD2:2020 |
IEC 60601-1-9 Edition 1.2 2020-07 "Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design" |
| IEC 60601-1-10 | IEC 60601-1-10.2007 +AMD1:2013 +AMD2:2020 | IEC 60601-1-10 Edition 1.2 2020-07 "Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers" |
| IEC 60601-1-11 | IEC 60601-1-11:2015+AMD1:2020 | IEC 60601-1-11 Edition 2.1 2020-07 "Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment" |
| IEC 60601-1-12 | IEC 60601-1-12:2014+AMD1:2020 | IEC 60601-1-12 Edition 1.1 2020-07 "Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment" |
| IEC 62366-1 | IEC 62366-1:2015/AMD1:2020 | IEC 62366-1 Edition 1.0 2020-06 AMENDMENT 1 "Medical devices – Part 1: Application of usability engineering to medical devices |
Produktstandarder (IEC 60601-2-XX)
IEC 60601-2-XX-standarderna är produktstandarder som gäller specifika typer av medicinsk elektrisk utrustning. De definierar detaljerade krav på säkerhet och prestanda för respektive produktkategori.
De bygger vidare på både grundstandarden och kollaterala standarder och säkerställer att produkterna fungerar säkert i sina specifika medicinska användningsområden.
| EXEMPEL PÅ PRODUKSTANDARDER | ||
| IEC 60601-2-1 | IEC 60601-2-1 Edition 4.0 (2020-10) | IEC 60601-2-1 Edition 4.0 (2020-10) "Medical electrical equipment – Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV" |
| IEC 60601-2-2 | IEC 60601-2-2:2017+AMD1:2023 | IEC 60601-2-2 E dition 6.1 2023-02 "Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" |
| IEC 60601-2-3 | IEC 60601-2-3:2012+AMD1:2016 +AMD2:2022 | IEC 60601-2-3:2012+AMD1:2016 +AMD2:2022 "Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment " |
| IEC 60601-2-4 | IEC 60601-2-6:2012+AMD1:2016 +AMD2:2022 |
IEC 60601-2-6 Edition 2.2 2022-09 "Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment" |
| IEC 60601-2-5 | IEC 60601-2-5 Edition 3.0 (2009-07) | IEC 60601-2-5 Edition 3.0 (2009-07) "Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment" |
| IEC 60601-2-6 | IEC 60601-2-6:2012+AMD1:2016 +AMD2:2022 |
IEC 60601-2-6 Edition 2.2 2022-09 "Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment" |
| IEC 60601-2-10 | IEC 60601-2-10:2012 +AMD1:2016 +AMD2:2023 | IEC 60601-2-10 Edition 2.2 2023-01 "Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators" |
| ISO 80601-2-12 | ISO 80601-2-12 Third edition (2023-11) | ISO 80601-2-12 Third edition (2023-11) "Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators" |
| ISO 80601-2-13 | ISO 80601-2-13:2011/Amd.1:2015 | ISO 80601-2-13:2011/Amd.1:2015 : "Medical electrical equipment - Part 2-13: "Particular requirements for basic safety and essential performance of an anaesthetic workstation, AMD 1" |
| IEC 60601-2-16 | IEC 60601-2-16:2018 | IEC 60601-2-16 Edition 5.0 2018-04 "Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment" |
| IEC 60601-2-18 | 60601-2-18:2009 | IEC 60601-2-18 Edition 3.0 2009-08 "Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment" |
| IEC 60601-2-19 | IEC 60601-2-19:2020 +AMD1:2023 | IEC 60601-2-19:2020 +AMD1:2023 "Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators" |
| IEC 60601-2-20 | IEC 60601-2-20:2020 | IEC 60601-2-20 Edition 3.0 2020-09 "Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators" |
| IEC 60601-2-21 | IEC 60601-2-21:2020 +AMD1:2023 | IEC 60601-2-21:2020 +AMD1:2023 "Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers" |
| IEC 60601-2-22 | IEC 60601-2-22:2019 | IEC 60601-2-22 Edition 4.0 2019-11 "Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment" |
| IEC 60601-2-24 | IEC 60601-2-24:2012 | IEC 60601-2-24 Edition 2.0 2012-10 "Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers" |
| IEC 60601-2-25 | IEC 60601-2-25:2011 | IEC 60601-2-25 Edition 2.0 2011-10 "Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs" |
| IEC 80601-2-26 | IEC 80601-2-26 Edition 1.0 (2019-05) | IEC 80601-2-26 Edition 1.0 (2019-05) "Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs" |
| IEC 60601-2-27 | IEC 60601-2-27:2011 | IEC 60601-2-27 Edition 3.0 2011-03 "Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment" |
| IEC 60601-2-29 | IEC 60601-2-29 Edition 3.0 (2008-06) | IEC 60601-2-29 Edition 3.0 (2008-06) "Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators" |
| IEC 80601-2-30 | IEC 80601-2-30 Edition 2.0 (2018-03) | IEC 80601-2-30 Edition 2.0 (2018-03) "Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers" |
| IEC 60601-2-33 | IEC 60601-2-33:2022/ISH1:2023 | IEC 60601-2-33 Edition 4.0 2022-08 "Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" |
| IEC 60601-2-34 | IEC 60601-2-34 Edition 4.0 (2024-10) | IEC 60601-2-34 Edition 4.0 (2024-10) "Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment" |
| IEC 60601-2-35 | IEC 60601-2-35:2020 +AMD1:2023 | IEC 60601-2-35:2020 +AMD1:2023 "Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use |
| IEC 60601-2-36 | IEC 60601-2-36:2014 | IEC 60601-2-36 Edition 2.0 2014-04 "Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy" |
| IEC 60601-2-37 | IEC 60601-2-37 Edition 3.0 (2024-07) | IEC 60601-2-37 Edition 3.0 (2024-07) "Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment" |
| IEC 60601-2-39 | IEC 60601-2-39 Edition 3.0 (2018-04) | IEC 60601-2-39 Edition 3.0 (2018-04) "Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment" |
| IEC 60601-2-40 | IEC 60601-2-40:2016 | IEC 60601-2-40 Edition 2.0 2016-08 "Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment" |
| IEC 60601-2-41 | IEC 60601-2-41 Edition 2.0 (2013-10) | IEC 60601-2-41 Edition 2.0 (2013-10) "Medical electrical equipment – Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis Ammendment 1" |
| IEC 60601-2-43 | IEC 60601-2-43:2022 | IEC 60601-2-43 Edition 3.0 2022-12 "Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedure" |
| IEC 60601-2-44 | IEC 60601-2-44:2009 +AMD1:2012 +AMD2:2016 | IEC 60601-2-44:2009 +AMD1:2012 +AMD2:2016 "Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography" |
| IEC 60601-2-45 | IEC 60601-2-45:2011 +AMD1:2015 +AMD2:2022 | IEC 60601-2-45:2011 +AMD1:2015 +AMD2:2022 "Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices" |
| IEC 60601-2-46 | IEC 60601-2-46 Edition 4.0 (2023-05) | IEC 60601-2-46 Edition 4.0 (2023-05) "Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables" |
| IEC 60601-2-47 | IEC 60601-2-47:2012 | IEC 60601-2-47 Edition 2.0 2012-02 "Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems" |
| IEC 80601-2-49 | IEC 80601-2-49:2018 | IEC 80601-2-49 Edition 1.0 2018-03 "Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors" |
| IEC 60601-2-50 | IEC 60601-2-50:2020 +AMD1:2023 | IEC 60601-2-50:2020 +AMD1:2023 "Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment" |
| IEC 60601-2-52 | IEC 60601-2-52:2009 +AMD1:2015 |
IEC 60601-2-52 Edition 1.1 2015-03 "Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds" |
| IEC 60601-2-54 | IEC 60601-2-54:2022 | IEC 60601-2-54 Edition 2.0 2022-09 "Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy" |
| ISO 80601-2-55 | ISO 80601-2-55 First edition (2011-12-15) | ISO 80601-2-55 First edition (2011-12-15) "Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors " |
| ISO 80601-2-56 | ISO 80601-2-56:2017+A1:2020 | ISO 80601-2-56:2017 +A1:2020 (May 2020) "Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement" |
| IEC 60601-2-57 | IEC 60601-2-57:2023 | IEC 60601-2-57 Edition 2.0 2023-07 "Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use |
| IEC 80601-2-58 | IEC 80601-2-58:2014+AMD1:2016 | IEC 80601-2-58 Edition 2.1 2016-10 "Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| IEC 80601-2-59 | IEC 80601-2-59:2017 +AMD1:2023 | IEC 80601-2-59 Edition 2.1 2023-01 "Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening" |
| IEC 80601-2-60 | IEC 80601-2-60:2019 | IEC 80601-2-60 Edition 2.0 2019-06 "Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment" |
| ISO 80601-2-61 | ISO 80601-2-61:2019 | ISO 80601-2-61:2017, Corrected version 2018-02 "Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment" |
| IEC 60601-2-62 | IEC 60601-2-62 Edition 1.0 (2013-07) | IEC 60601-2-62 Edition 1.0 (2013-07) "Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment" |
| IEC 60601-2-63 | IEC 60601-2-63:2012+A1:2017 +A2:2021 | IEC 60601-2-63:2012 +A1:2017 +A2:2021 "Medical electrical equipment – Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment" |
| IEC 60601-2-64 | IEC 60601-2-64 Edition 1.0 (2014-09) | IEC 60601-2-64 Edition 1.0 (2014-09) "Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment" |
| IEC 60601-2-65 | IEC 60601-2-65:2012 +AMD1:2017 +AMD2:2021 | IEC 60601-2-65:2012 +AMD1:2017 +AMD2:2021 "Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment " |
| IEC 60601-2-66 | IEC 60601-2-66:2019 | IEC 60601-2-66 Edition 3.0 2019-10 "Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems" |
| ISO 80601-2-67 | ISO 80601-2-67:2020 | ISO 80601-2-67:2020 "Medical elctrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment" |
| IEC 60601-2-68 | IEC 60601-2-68 Edition 1.0 (2014-09) | IEC 60601-2-68 Edition 1.0 (2014-09) "Medical electrical equipment – Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment" |
| ISO 80601-2-69 | ISO 80601-2-69:2020 | ISO 80601-2-69:2020 "Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment" |
| ISO 80601-2-70 | ISO 80601-2-70:2020 | ISO 80601-2-70:2020 "Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment" |
| IEC 80601-2-71 | IEC 80601-2-71 Edition 1.0 (2015-06) | IEC 80601-2-71 Edition 1.0 (2015-06) "Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment" |
| ISO 80601-2-72 | ISO 80601-2-72 First edition (2015‐09‐01) | ISO 80601-2-72 First edition (2015‐09‐01) "Medical electrical equipment - Part 2‐72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients" |
| ISO 80601-2-74 | ISO 80601-2-74:2021 | ISO 80601-2-74:2021 "Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| IEC 60601-2-75 | IEC 60601-2-75:2017 +AMD1:2023 | IEC 60601-2-75 Edition 1.1 2023-01 "Medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment" |
| IEC 60601-2-76 | IEC 60601-2-76:2018 +AMD1:2023 | IEC 60601-2-76 Edition 1.1 2023-08 "Medical electrical equipment – Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment" |
| IEC 80601-2-77 | IEC 80601-2-77:2019 | IEC 80601-2-77 Edition 1.0 2019-07 "Medical electrical equipment – Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT" |
| IEC 80601-2-78 | IEC 80601-2-78 Edition 1.0 (2019-07) | IEC 80601-2-78 Edition 1.0 (2019-07) "Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation" |
| ISO 80601-2-79 | ISO 80601-2-79 First edition (2018-07) | ISO 80601-2-79 First edition (2018-07) "Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment" |
| ISO 80601-2-80 | ISO 80601-2-80 First edition (2018-07) | ISO 80601-2-80 First edition (2018-07) "Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency" |
| IEC 60601-2-83 | IEC 60601-2-83:2019 +AMD1:2022 | IEC 60601-2-83 Edition 1.1 2022-12 "Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment" |
| ISO 80601-2-84 | ISO 80601-2-84 First edition (2020-07) | ISO 80601-2-84 First edition (2020-07) "Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment" |
| ISO 80601-2-85 | ISO 80601-2-85:2021 first edition (2021-03) | ISO 80601-2-85:2021 First edition (2021-03) "Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment" |
| ISO 80601-2-87 | ISO 80601-2-87:2021 first edition (2021-04) | ISO 80601-2-87:2021 First Edition (2021-04) "Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators" |
| ISO 80601-2-90 | ISO 80601-2-90:2021 | ISO 80601-2-90:2021 "Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment" |
| ISO 10079-1 | ISO 10079-1: 2022 | ISO 10079-1 (2022) "Medical suction equipment - Part 1: electrically powered suction equipment" |
| ISO 10079-4 | ISO 10079-4:2021 | ISO 10079-4 (2021) "Medical suction equipment - Part 4: General requirements" |
Interteks lösningar för IEC 60601-1
Som ett OSHA-godkänt NRTL (Nationally Recognized Testing Laboratory) är Intertek en ledande leverantör av provning, certifiering och tekniskt stöd för IEC 60601-serien.
Med global expertis hjälper vi dig att:
- identifiera tillämpliga standarder
- säkerställa korrekt implementering
- verifiera efterlevnad genom provning
Genom standardbaserad provning kan du styrka säkerhetskrav och få tillgång till marknader i Nordamerika, Europa och globalt.
Vi erbjuder heltäckande stöd genom hela processen – från produktutveckling och granskning av riskhanteringsdokumentation till fullständig provning enligt IEC 60601- och IEC 80601-serierna, inklusive både kollateral- och produktstandarder.
Intertek är din partner genom hela provnings- och certifieringsprocessen.