--- title: IEC 62353 and electrical safety testing calibration - a guide for medical manufacturers description: IEC 62353 is the international standard for recurrent testing and testing after repair of medical electrical equipment. image: https://blog.dmsystemsgroup.co.uk/hubfs/medical%20calibration.jpg --- - About us ![DM-Master\_Blue-Black](https://blog.dmsystemsgroup.co.uk/hs-fs/hubfs/DM-Master_Blue-Black.webp?width=256&height=183&name=DM-Master_Blue-Black.webp) We’re a customer-led organisation that’s supported by the world’s leading experts in both defence and commercial sectors. 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For medical device manufacturers, calibrating this equipment is therefore a compliance requirement in practice, because ISO 13485 requires measuring equipment used to evidence product safety to be calibrated and traceable. ## What is IEC 62353? [IEC 62353:2014](https://webstore.iec.ch/en/publication/6913) sets out electrical safety tests for medical electrical (ME) equipment and systems before they are put into service, during maintenance, inspection and servicing, and after repair. The current edition (2.0) was published in 2014. In the UK, the MHRA's [Managing Medical Devices guidance](https://assets.publishing.service.gov.uk/media/6089dc938fa8f51b91f3d82f/Managing_medical_devices.pdf) notes that BS EN 62353:2014 is not a designated standard under the UK Medical Devices Regulations 2002, but recommends following it as best practice. ## How does IEC 62353 differ from IEC 60601-1? IEC 60601-1 is the design and type-testing standard that proves a device is safe by design, while IEC 62353 confirms that equipment remains safe once in service or after repair. The standard itself states it is not suitable for assessing whether equipment complies with design standards. Its tests are simpler and non-destructive: protective earth testing, for example, uses a minimum test current of 200 mA rather than the 25 A used in type testing, avoiding damage to the equipment, as [Rigel Medical explains](https://www.mddionline.com/testing/safety-testing-medical-devices-iec-62353-explained). For manufacturers, IEC 62353 is most relevant to service, repair and returns activities, and to checks carried out before equipment is put into service. ## Which tests does IEC 62353 include? IEC 62353 testing follows a sequence of visual inspection, electrical measurements and a functional test. Typical limits for a Class I device are shown below, although the device manufacturer [should always confirm the applicable pass/fail criteria](https://www.trsrentelco.com/sites/default/files/content/resource/pdf/2026-07/Rigel%20Medical%20-%20A%20Practical%20Guide%20to%20IEC%2062353.pdf). | **Test** | **What it checks** | **Typical limit** | **Test equipment** | | --- | --- | --- | --- | | Protective earth resistance | Integrity of the earth connection | 300 mΩ (including power cable up to 3 m) | Safety analyser or earth bond tester | | Insulation resistance | Insulation between mains parts and earth | ≥2 MΩ at 500 V DC (mains to earth) | Insulation resistance tester | | Equipment leakage current | Total leakage, protecting the operator | 500 µA (direct or differential method) | Electrical safety analyser | | Applied part leakage current | Leakage through patient-connected parts | 50 µA (Type CF), 5,000 µA (Type BF) | Electrical safety analyser | ## Why must electrical safety test equipment be calibrated under strict criteria? Electrical safety test equipment must be calibrated because an inaccurate reading can pass equipment that is unsafe for patients or fail equipment that is perfectly sound. With a CF applied part limit of 50 µA, small errors matter. Rigel warns that analysers specifying accuracy as a percentage of full scale can compromise low leakage readings, which is why calibration should check performance across the ranges you actually use. IEC 62353 does not act as a calibration standard, but its normative Annex C defines requirements for the measurement equipment and circuits used. Calibration obligations then come from your quality system: ISO [13485:2016 clause 7.6](https://www.iso.org/obp/ui/#iso:std:iso:13485:ed-3:v1:en) requires measuring equipment used to demonstrate conformity to be calibrated against traceable standards, and the MHRA expects service providers to ensure test equipment is "adequately maintained and calibrated". ## What electrical safety test equipment needs calibrating? Any instrument whose readings are used to make a pass/fail safety decision should be included in your calibration programme. Common examples include: - electrical safety analysers; - earth bond and protective conductor testers; - insulation resistance testers; - PAT testers with medical test modes; - flash (dielectric strength) testers used in production; - multimeters used for supporting measurements. IEC 62353 does not specify how often these should be calibrated. Intervals should be set using manufacturer recommendations, frequency of use and calibration history, as covered in our guide to [building a calibration schedule](https://blog.dmsystemsgroup.co.uk/how-to-build-a-calibration-schedule-for-your-test-equipment). ## Why choose on-site calibration for safety test equipment? On-site calibration allows manufacturers to keep critical safety test equipment on their premises, avoiding the transit risk and downtime of sending it to a laboratory. When a safety analyser is away for calibration, service and repair testing stalls. [On-site electrical calibration](https://blog.dmsystemsgroup.co.uk/how-on-site-electrical-calibration-minimises-manufacturing-downtime) returns equipment to use the same day, with full traceability maintained. ## Keep electrical safety testing accurate with DM Reliable electrical safety testing depends on equipment you can trust to make accurate pass or fail decisions. Calibrating your testers across the measurement ranges you use helps you maintain confidence in results and support traceability throughout service and repair activities. At DM, our dedicated electrical calibration laboratory supports insulation testers, earth bond testers, PAT testers, flash testers and multimeters. As UKAS Calibration Laboratory No. 0143, we provide accredited calibration within our published scope, with on-site services available to help reduce equipment downtime. Download our guide below to find out more.  [![Free download   The Medical Device Manufacturer's Calibration Compliance Checklist   Download our guide to medical device calibration compliance.](https://no-cache.hubspot.com/cta/default/8834937/interactive-222703092005.png)](https://blog.dmsystemsgroup.co.uk/hs/cta/wi/redirect?encryptedPayload=AVxigLIEen1uo00tceKUc9PlTMhubdNCN9Fs1AGD7CsHrQRq9ZKn4JOZ81PQUzT644KQFjirVk78ElrDOSarTf0CorEms1AQMzjN1L3IdBqOV26HZgxOdmBDnuqLPx%2FwayHrUoYhbIzY%2B%2FO8WLIQdX19mqkGJIuLKLPMM8cP%2F8GfmF4lNIiZfH8fai8zluDHEk6%2FwSDg%2B%2BwjvFPltZY5wxHjB7LZbx57Zt3xArQNHCWwVODHAbQOzQrInbLnXDv9duqt7UxSYE3fdcaWt%2FU5%2FqPdRSq50vsJRvjh5yI%3D&webInteractiveContentId=222703092005&portalId=8834937) ### Book your calibration now Our experts are on-hand to handle all of your calibration needs. 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