{"id":18280,"date":"2026-10-05T15:19:31","date_gmt":"2026-10-05T18:19:31","guid":{"rendered":"https:\/\/arkmeds.com\/?p=18280"},"modified":"2026-10-05T20:37:51","modified_gmt":"2026-10-05T23:37:51","slug":"electrical-safety-after-repair-iec-62353-study","status":"publish","type":"post","link":"https:\/\/arkmeds.com\/en\/blog\/electrical-safety-after-repair-iec-62353-study\/","title":{"rendered":"Is repaired medical equipment ready for use? IEC 62353 explained"},"content":{"rendered":"\n<style>.ark-research{--ark-teal:#0097A9;--ark-slate:#244C5A;--ark-yellow:#FFC72C;font-family:Montserrat,Arial,sans-serif;color:#244C5A;max-width:900px;margin:0 auto;font-size:18px;line-height:1.85;text-align:left}\n.ark-research *{box-sizing:border-box}.ark-research p{margin:0 0 1.4em}.ark-research h2{font-size:clamp(24px,3.2vw,34px);line-height:1.3;font-weight:700;color:#244C5A;text-transform:none!important;margin:2.6em 0 .8em;scroll-margin-top:100px}.ark-research a{color:#007A89;text-decoration:underline;text-underline-offset:4px;transition:color .15s ease}.ark-research a:hover,.ark-research a:focus{color:#244C5A}.ark-research .ark-byline{font-size:15px;line-height:1.65;margin:0 0 24px;padding-bottom:20px;border-bottom:2px solid #0097A9}.ark-research .ark-lead{font-size:clamp(20px,2.3vw,24px);line-height:1.65;font-weight:500}.ark-research .ark-photo-note{font-size:13px;line-height:1.6;color:#536D76;margin:0 0 28px}.ark-research 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.ark-answer-label{font-size:13px;font-weight:700;letter-spacing:.035em;margin-bottom:12px;text-transform:uppercase}.ark-research .ark-table-scroll{width:100%;overflow-x:auto;margin:26px 0 32px}.ark-research .ark-table-scroll:focus-visible{outline:2px solid #0097A9;outline-offset:4px}.ark-research table{border-collapse:collapse;width:100%;font-size:15px;line-height:1.65;text-align:left}.ark-research th,.ark-research td{padding:17px 15px;vertical-align:top;border-bottom:1px solid #D7EBEE}.ark-research thead th{background:#EAF2F3;border-top:3px solid #0097A9;font-weight:700}.ark-research tbody th{font-weight:650;min-width:125px}.ark-research table:has(th:nth-child(3)){min-width:550px}.ark-research .ark-ref{font-size:14px;white-space:nowrap}.ark-research .ark-toc{margin-bottom:36px}.ark-research .ark-toc li{padding:4px 0}.ark-research .ark-credit{font-size:13px}.ark-research .ark-photo-note a{white-space:nowrap}\n@media(max-width:600px){.ark-research .ark-answer{padding-left:18px}.ark-research th,.ark-research td{padding:14px 11px}.ark-research table{font-size:14px}.ark-research tbody th{min-width:105px}.ark-research .ark-product figure{margin-bottom:12px}}\n\n.ark-research .ark-takeaways{padding-left:25px;margin:24px 0}.ark-research .ark-takeaways li{padding:8px 0 16px;line-height:1.75}\n.ark-research .ark-product-steps{padding-left:28px;margin:24px 0}.ark-research .ark-product-steps li{padding:7px 0 12px}.ark-research .ark-product-cta{display:inline-block;max-width:100%;padding:14px 20px;min-height:44px;background:#244C5A;color:#fff;font-size:16px;font-weight:650;line-height:1.6;text-decoration:none}.ark-research .ark-product-cta:hover,.ark-research .ark-product-cta:focus{background:#244C5A;color:#FFC72C}.ark-research .ark-product-cta:focus-visible{outline:3px solid #FFC72C;outline-offset:4px}.ark-research .ark-product img{height:auto;object-fit:contain}\n<\/style>\n<article class=\"ark-research\" lang=\"en\"><div class=\"ark-byline\">By <strong>Thiago Bajur<\/strong> \u00b7 CEO of Arkmeds<br><time datetime=\"2026-10-05\">Updated 5 October 2026<\/time><\/div><p class=\"ark-photo-note\">AI-generated editorial illustration: inspection of a disconnected power cord and documentation of the verification. It does not depict a real test.<\/p><p class=\"ark-lead\">The monitor displays a waveform again, its connector has been repaired and the work order is nearly closed. <strong>Is the device ready to return to service?<\/strong> In this illustrative case, restoring function is only part of the answer. Research on post-repair testing shows why the accompanying cord and the release record also deserve attention.<\/p><section class=\"ark-answer\" aria-label=\"The answer in brief\"><p class=\"ark-answer-label\">The answer in brief<\/p><p><strong>Restored function alone does not complete the verification.<\/strong> Before releasing repaired equipment, collect the applicable electrical-safety and performance results, identify the device and accessories evaluated, and record who authorised release. IEC 62353 addresses recurrent and post-repair testing; selecting the checks also depends on the device and the manufacturer\u2019s instructions. <a href=\"https:\/\/webstore.iec.ch\/en\/publication\/6913\" class=\"ark-ref\">[2]<\/a><a href=\"https:\/\/www.gov.uk\/government\/publications\/managing-medical-devices\" class=\"ark-ref\">[4]<\/a><\/p><\/section><nav class=\"ark-toc\" aria-label=\"In this article\"><strong>In this article<\/strong><ol><li><a href=\"#ark-researchQ\">What did the 2026 hospital study find?<\/a><\/li><li><a href=\"#ark-cordQ\">Why should the power cord be part of the investigation?<\/a><\/li><li><a href=\"#ark-timeQ\">How long did testing take, and can that be a local target?<\/a><\/li><li><a href=\"#ark-standardQ\">What is the difference between IEC 62353 and IEC 60601-1?<\/a><\/li><li><a href=\"#ark-performanceQ\">Does a functional check replace an electrical safety test?<\/a><\/li><li><a href=\"#ark-checksQ\">Which checks matter before return to service?<\/a><\/li><li><a href=\"#ark-caseQ\">How can an investigation be documented without losing the initial result?<\/a><\/li><li><a href=\"#ark-recordQ\">What should a post-repair release record contain?<\/a><\/li><li><a href=\"#ark-productQ\">How does Tesla take a test through to a signed report?<\/a><\/li><li><a href=\"#ark-takeawayQ\">Three questions for the next handover<\/a><\/li><\/ol><\/nav><h2 id=\"ark-researchQ\">What did the 2026 hospital study find?<\/h2><p>Nunes and colleagues reported <strong>393 tests: 363 initial tests and 30 retests<\/strong>, at one public hospital in Curitiba, Brazil. Data were collected from January 2024 to March 2025. Reported nonconformity rates were <strong>23.7% after repair and 7.7% in recurrent testing<\/strong>. <a href=\"https:\/\/doi.org\/10.1007\/s42600-026-00486-y\" class=\"ark-ref\">[1]<\/a><\/p><figure class=\"ark-chart\"><div class=\"ark-chart-title\">Reported nonconformity rates<\/div><div class=\"ark-bar-row\"><span class=\"ark-bar-label\">Recurrent tests<\/span><div class=\"ark-track\" aria-hidden=\"true\"><span class=\"ark-fill \" style=\"width:25.67%\"><\/span><\/div><strong class=\"ark-bar-value\">7.7%<\/strong><\/div><div class=\"ark-bar-row\"><span class=\"ark-bar-label\">Post-repair tests<\/span><div class=\"ark-track\" aria-hidden=\"true\"><span class=\"ark-fill yellow\" style=\"width:79.00%\"><\/span><\/div><strong class=\"ark-bar-value\">23.7%<\/strong><\/div><figcaption>Different testing situations in one hospital. Data adapted from Nunes et al. (2026), CC BY 4.0.<\/figcaption><\/figure><p>That is a <strong>16-percentage-point difference<\/strong>, calculated from the published rates. It does not prove that repairs caused the failures: the groups differ and are not a controlled before-and-after experiment. For the technical team, the useful question is whether closing the work order includes evidence of verification after the intervention or only a description of the repair.<\/p><h2 id=\"ark-cordQ\">Why should the power cord be part of the investigation?<\/h2><p>Power cords accounted for <strong>18 of 25 protective-earth resistance failures<\/strong> in the study. That is 72% of this failure category, not 72% of tested equipment. <a href=\"https:\/\/doi.org\/10.1007\/s42600-026-00486-y\" class=\"ark-ref\">[1]<\/a><\/p><figure class=\"ark-chart\"><div class=\"ark-failure\"><div class=\"ark-waffle\" aria-hidden=\"true\"><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square cord\"><\/i><i class=\"ark-square \"><\/i><i class=\"ark-square \"><\/i><i class=\"ark-square \"><\/i><i class=\"ark-square \"><\/i><i class=\"ark-square \"><\/i><i class=\"ark-square \"><\/i><i class=\"ark-square \"><\/i><\/div><div><strong>18 \/ 25<\/strong><p>Attributed to the power cord<br>72%<\/p><span>Other protective-earth failures: 7<\/span><\/div><\/div><figcaption>Each square represents one failure in this category. Nunes et al. (2026); original visualisation, CC BY 4.0 data.<\/figcaption><\/figure><p>A separate Indian study examined 200 Class I devices. In a 20-device subset, median earth resistance was <strong>84.5 versus 580 m\u03a9<\/strong> with medical-grade and supplied non-medical-grade cords respectively. The results cannot be pooled with the Brazilian rates. <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC4743298\/\" class=\"ark-ref\">[3]<\/a><\/p><p><strong>A failure attributed to a cord is not automatically an internal device defect.<\/strong> Keep the evaluated cord, initial finding and any accessory change identifiable during the investigation. If the cord changes between testing and handover, record that change: a context-free \u201cpass\u201d loses part of its meaning.<\/p><h2 id=\"ark-timeQ\">How long did testing take, and can that be a local target?<\/h2><p>The reported mean was <strong>5.34 minutes, SD 1.71, across 363 initial tests<\/strong>, including preparation and documentation. <a href=\"https:\/\/doi.org\/10.1007\/s42600-026-00486-y\" class=\"ark-ref\">[1]<\/a> Treat it as context, not a promised turnaround. To plan locally, measure preparation, applicable checks and record completion separately, then identify which stage consumes time.<\/p><h2 id=\"ark-standardQ\">What is the difference between IEC 62353 and IEC 60601-1?<\/h2><p><strong>IEC 62353<\/strong> concerns safety assessment during the equipment&#x27;s service life. <strong>IEC 60601-1<\/strong> concerns basic safety and essential performance requirements. A satisfactory post-repair test is not a certification of design compliance. <a href=\"https:\/\/webstore.iec.ch\/en\/publication\/6913\" class=\"ark-ref\">[2]<\/a><a href=\"https:\/\/webstore.iec.ch\/en\/publication\/67497\" class=\"ark-ref\">[5]<\/a><\/p><div class=\"ark-table-scroll\" role=\"region\" tabindex=\"0\" aria-label=\"What is the difference between IEC 62353 and IEC 60601-1?\"><table><thead><tr><th scope=\"col\">Reference<\/th><th scope=\"col\">Scope<\/th><th scope=\"col\">Practical consequence<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">IEC 62353:2014 \u00b7 edition 2.0<\/th><td>Recurrent and post-repair testing of medical electrical equipment and systems.<\/td><td>Select the applicable in-service testing procedure.<\/td><\/tr><tr><th scope=\"row\">IEC 60601-1 \u00b7 consolidated edition 3.2 (2020)<\/th><td>Basic safety and essential performance; applicable particular standards also matter.<\/td><td>Do not equate a routine pass with full design compliance.<\/td><\/tr><tr><th scope=\"row\">Device manufacturer&#x27;s documentation<\/th><td>Instructions for the specific model and intervention.<\/td><td>Record the document and revision used to select checks.<\/td><\/tr><\/tbody><\/table><\/div><p class=\"ark-note\">These are scope summaries, not a reproduction of the standards. <strong>A numerical limit needs its method and configuration<\/strong>; do not copy a value from one study into every equipment checklist. National adoptions and legal duties require their own jurisdiction-specific verification.<\/p><h2 id=\"ark-performanceQ\">Does a functional check replace an electrical safety test?<\/h2><p><strong>No: performance and electrical safety answer different questions.<\/strong> WHO distinguishes performance inspection from safety inspection. The MHRA recommends applicable electrical-safety and performance testing before return to service; this is UK guidance, not a statement of Brazilian legal requirements. <a href=\"https:\/\/www.who.int\/publications\/i\/item\/9789241501538\" class=\"ark-ref\">[6]<\/a><a href=\"https:\/\/www.gov.uk\/government\/publications\/managing-medical-devices\" class=\"ark-ref\">[4]<\/a><\/p><figure><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/arkmeds.com\/wp-content\/uploads\/2026\/10\/arkmeds-lab-after-repair-en.jpg\" alt=\"Arkmeds technician using Waller to verify a monitor&#x27;s functional responses.\" width=\"1200\" height=\"720\" loading=\"lazy\"\/><figcaption>Arkmeds laboratory: functional verification of a monitor with the Waller patient simulator. This illustrates the performance side of the handover, rather than an electrical safety measurement.<\/figcaption><\/figure><p>For a monitor, displaying a waveform helps answer whether a function responds. It does not answer the same question as an earth-resistance or leakage-current result. A useful handover links both sets of evidence to the device, without treating one as a substitute for the other.<\/p><h2 id=\"ark-checksQ\">Which checks matter before return to service?<\/h2><p>The following is a <strong>map of questions and evidence<\/strong>, not an execution sequence. Applicability, methods and acceptance criteria come from the technical procedure selected for the equipment.<\/p><div class=\"ark-table-scroll\" role=\"region\" tabindex=\"0\" aria-label=\"Which checks matter before return to service?\"><table><thead><tr><th scope=\"col\">Area<\/th><th scope=\"col\">Question to resolve<\/th><th scope=\"col\">Evidence to preserve<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">Visual condition<\/th><td>What was inspected, including relevant accessories?<\/td><td>Findings and accessory identification.<\/td><\/tr><tr><th scope=\"row\">Protective earth<\/th><td>Where applicable, which protective-earth path was assessed?<\/td><td>Measurement points, resistance and units (\u03a9 or m\u03a9).<\/td><\/tr><tr><th scope=\"row\">Leakage current<\/th><td>Which method and equipment\/applied-part configuration were evaluated?<\/td><td>Measured current, units, configuration and criterion source.<\/td><\/tr><tr><th scope=\"row\">Insulation<\/th><td>Is the measurement applicable to this device and intervention?<\/td><td>Selection rationale, method and result when applicable.<\/td><\/tr><tr><th scope=\"row\">Performance<\/th><td>Do the relevant functions meet the selected specifications?<\/td><td>Function tested, reference\/simulator, result and criteria.<\/td><\/tr><\/tbody><\/table><\/div><p>The same number can have different meanings under different configurations. <strong>Preserve the measured value and its context<\/strong>, rather than only exporting a green pass label. The research&#x27;s equipment and methods are described in the original paper. <a href=\"https:\/\/doi.org\/10.1007\/s42600-026-00486-y\" class=\"ark-ref\">[1]<\/a><\/p><h2 id=\"ark-caseQ\">How can an investigation be documented without losing the initial result?<\/h2><p><strong>Illustrative documentation example<\/strong>, using fictional identifiers and no invented readings: monitor MON-014 has had a connector repaired. Its functional check is recorded, but initial test IN-01 identifies a protective-earth nonconformity. The device remains pending release while the team investigates under the applicable procedure.<\/p><div class=\"ark-table-scroll\" role=\"region\" tabindex=\"0\" aria-label=\"How can an investigation be documented without losing the initial result?\"><table><thead><tr><th scope=\"col\">Stage<\/th><th scope=\"col\">What the record needs to let a reviewer reconstruct<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">Initial finding<\/th><td>IN-01 linked to MON-014 and cord CAB-01; values, units, method, configuration and criterion are completed using the actual results.<\/td><\/tr><tr><th scope=\"row\">Investigation and correction<\/th><td>Record what was examined and the technical reason for the action. If a cord is replaced, identify the previous and new accessories, for example CAB-01 and CAB-02.<\/td><\/tr><tr><th scope=\"row\">Retest<\/th><td>RT-02 linked to IN-01, identifying the accessory actually evaluated and the results of applicable checks. The original record remains available.<\/td><\/tr><tr><th scope=\"row\">Decision<\/th><td>Authorise release or retain the device based on the complete evidence and procedure; record the responsible person, date and communication to the user.<\/td><\/tr><\/tbody><\/table><\/div><p>The example shows <strong>how to preserve the chain of evidence<\/strong>, without diagnosing the cause or authorising release after a cord replacement. A later technician can see what changed between the initial test and retest. MHRA guidance calls for retrievable records and changes that do not obscure earlier information. <a href=\"https:\/\/www.gov.uk\/government\/publications\/managing-medical-devices\" class=\"ark-ref\">[4]<\/a><\/p><h2 id=\"ark-recordQ\">What should a post-repair release record contain?<\/h2><p>The case above shows how to link an initial finding to its retest. The table below expands that into the <strong>information needed to reconstruct the release decision<\/strong>. Its fictional MON-014 example is a documentation aid, not a measured test result.<\/p><div class=\"ark-table-scroll\" role=\"region\" tabindex=\"0\" aria-label=\"What should a post-repair release record contain?\"><table><thead><tr><th scope=\"col\">Field<\/th><th scope=\"col\">Example of useful documentation<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">Asset and intervention<\/th><td>Asset MON-014 (fictional); model\/serial; repair order; connector replaced.<\/td><\/tr><tr><th scope=\"row\">Procedure and configuration<\/th><td>Procedure ID\/revision; equipment class and applied-part type; accessories and method used.<\/td><\/tr><tr><th scope=\"row\">Results and criteria<\/th><td>Measured value + unit; acceptance criterion + source; result of each applicable check.<\/td><\/tr><tr><th scope=\"row\">Test equipment<\/th><td>Analyser\/simulator ID and applicable calibration reference.<\/td><\/tr><tr><th scope=\"row\">Initial test and retest<\/th><td>Link the finding, corrective action and later verification; retain both records.<\/td><\/tr><tr><th scope=\"row\">Release decision<\/th><td>Release\/hold decision; responsible person; date; communication to the user.<\/td><\/tr><\/tbody><\/table><\/div><p class=\"ark-note\"><strong>A later pass should not erase an earlier failure.<\/strong> Preserve the history so a reviewer can follow the decision without relying on someone&#x27;s memory. This template is an editorial implementation aid; MHRA \u00a7\u00a72.4 and 8.7 discuss retrievable records and return-to-service testing. <a href=\"https:\/\/www.gov.uk\/government\/publications\/managing-medical-devices\" class=\"ark-ref\">[4]<\/a><\/p><h2 id=\"ark-productQ\">How does Tesla take a test through to a signed report?<\/h2><p>Once the checks are defined, the next task is to <strong>keep measurements linked to the equipment and turn them into a report for the client<\/strong>. This is where a connected analyser can support the workflow.<\/p><div class=\"ark-product\"><figure><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/arkmeds.com\/wp-content\/uploads\/2026\/10\/tesla-powered-on.jpg\" alt=\"Close-up of an Arkmeds Tesla analyser powered on, showing earth-resistance, insulation and leakage-current services on screen.\" width=\"680\" height=\"650\" loading=\"lazy\"\/><figcaption>Tesla powered on: close-up of the panel and available services. Arkmeds image archive; no test result is shown. The cited research used another analyser.<\/figcaption><\/figure><div><p>With <strong>Arkmeds Tesla and Mark II<\/strong>, you run automated electrical-safety tests from an Android phone through Bluetooth, keeping readings linked to the work order. Tesla brings together earth-resistance, insulation and leakage measurements. <a href=\"https:\/\/arkmeds.com\/pt-br\/tesla-analisador-de-seguranca-eletrica\/\" class=\"ark-ref\">[7]<\/a><a href=\"https:\/\/arkmeds.com\/pt-br\/blog\/transformacao-digital-na-engenharia-clinica-como-o-mark-ii-a-ia-e-a-automacao-estao-redefinindo-o-futuro-da-saude\/\" class=\"ark-ref\">[8]<\/a><\/p><\/div><\/div><ol class=\"ark-product-steps\"><li><strong>Connect and run:<\/strong> select the equipment and procedure in the app, then start automated testing through Bluetooth. <a href=\"https:\/\/arkmeds.com\/pt-br\/tesla-analisador-de-seguranca-eletrica\/\" class=\"ark-ref\">[7]<\/a><a href=\"https:\/\/tesla.arkmeds.com\/\" class=\"ark-ref\">[9]<\/a><\/li><li><strong>Record without retyping readings:<\/strong> results populate the report and remain linked to the equipment. <a href=\"https:\/\/arkmeds.com\/pt-br\/blog\/transformacao-digital-na-engenharia-clinica-como-o-mark-ii-a-ia-e-a-automacao-estao-redefinindo-o-futuro-da-saude\/\" class=\"ark-ref\">[8]<\/a><\/li><li><strong>Generate the report in minutes:<\/strong> after measurements and review, the PDF is generated automatically. Total time varies with the checks and workflow configuration. <a href=\"https:\/\/arkmeds.com\/pt-br\/tesla-analisador-de-seguranca-eletrica\/\" class=\"ark-ref\">[7]<\/a><a href=\"https:\/\/arkmeds.com\/pt-br\/blog\/transformacao-digital-na-engenharia-clinica-como-o-mark-ii-a-ia-e-a-automacao-estao-redefinindo-o-futuro-da-saude\/\" class=\"ark-ref\">[8]<\/a><\/li><li><strong>Sign and deliver:<\/strong> the report can be electronically signed and made available to the client; the workflow also supports the requester\u2019s remote signature. <a href=\"https:\/\/arkmeds.com\/pt-br\/blog\/transformacao-digital-na-engenharia-clinica-como-o-mark-ii-a-ia-e-a-automacao-estao-redefinindo-o-futuro-da-saude\/\" class=\"ark-ref\">[8]<\/a><a href=\"https:\/\/arkmeds.arkmeds.com.br\/solucoes\/analisadores-e-simuladores-stran-lab\/analisador-de-seguranca-eletrica-tesla\" class=\"ark-ref\">[10]<\/a><\/li><\/ol><p>Operation is designed to be <strong>easy and intuitive<\/strong>, with a touchscreen, educational diagrams and customisable checklists. Its durable construction and compact format support technical work and transport. <a href=\"https:\/\/arkmeds.com\/pt-br\/tesla-analisador-de-seguranca-eletrica\/\" class=\"ark-ref\">[7]<\/a><a href=\"https:\/\/tesla.arkmeds.com\/\" class=\"ark-ref\">[9]<\/a><\/p><p>Data collection can work <strong>offline<\/strong>, with synchronisation once an internet connection is available. The connected workflow helps the team move from measurement to a document ready for review and delivery. <a href=\"https:\/\/tesla.arkmeds.com\/\" class=\"ark-ref\">[9]<\/a><\/p><p><a class=\"ark-product-cta\" href=\"https:\/\/arkmeds.com\/en\/tesla-electrical-safety-analyzer\/\">Explore Tesla<\/a><\/p><h2 id=\"ark-takeawayQ\">Three questions for the next handover<\/h2><ul class=\"ark-takeaways\"><li><strong>Which device and cord were actually evaluated?<\/strong> Identification connects the result to the tested configuration.<\/li><li><strong>Where are the results and criteria used?<\/strong> A pass indicator does not replace values, units and context.<\/li><li><strong>What changed between the failure and retest?<\/strong> Correction and subsequent verification need to be linked to the initial finding.<\/li><\/ul><p>These questions turn the article into a concrete topic for a team review. The aim is to reconstruct a release decision, including when someone else takes over the work.<\/p><h2 id=\"ark-faqQ\">One more question about testing intervals<\/h2><details><summary>Is there one universal interval for every device?<\/summary><p>Do not derive a universal interval from a study. MHRA \u00a78.1 relates planned maintenance to manufacturer instructions, expected use and environment. Define and document the applicable local schedule. <a href=\"https:\/\/www.gov.uk\/government\/publications\/managing-medical-devices\" class=\"ark-ref\">[4]<\/a><\/p><\/details><h2 id=\"ark-sourcesTitle\">Sources and editorial responsibility<\/h2><ol class=\"ark-sources\"><li id=\"ark-source-1\"><a href=\"https:\/\/doi.org\/10.1007\/s42600-026-00486-y\">Nunes, Barros &amp; Carvalho (2026). Implementation of IEC 62353:2014. Research on Biomedical Engineering 42, 40.<\/a><\/li><li id=\"ark-source-2\"><a href=\"https:\/\/webstore.iec.ch\/en\/publication\/6913\">IEC 62353:2014 \u2014 official scope and edition.<\/a><\/li><li id=\"ark-source-3\"><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC4743298\/\">Padmavathi, Prasad &amp; Kundra (2015). Does non-medical grade power cord compromise the safety of medical equipment?<\/a><\/li><li id=\"ark-source-4\"><a href=\"https:\/\/www.gov.uk\/government\/publications\/managing-medical-devices\">MHRA (2021). Managing Medical Devices, \u00a7\u00a72.4, 8.1 and 8.7.<\/a><\/li><li id=\"ark-source-5\"><a href=\"https:\/\/webstore.iec.ch\/en\/publication\/67497\">IEC 60601-1:2005+AMD1:2012+AMD2:2020 \u2014 consolidated edition 3.2.<\/a><\/li><li id=\"ark-source-6\"><a href=\"https:\/\/www.who.int\/publications\/i\/item\/9789241501538\">WHO (2011). Medical equipment maintenance programme overview.<\/a><\/li><li id=\"ark-source-7\"><a href=\"https:\/\/arkmeds.com\/pt-br\/tesla-analisador-de-seguranca-eletrica\/\">Arkmeds \u2014 Tesla technical product information.<\/a><\/li><li id=\"ark-source-8\"><a href=\"https:\/\/arkmeds.com\/pt-br\/blog\/transformacao-digital-na-engenharia-clinica-como-o-mark-ii-a-ia-e-a-automacao-estao-redefinindo-o-futuro-da-saude\/\">Arkmeds (2025) \u2014 Mark II: Bluetooth, reports and electronic signatures.<\/a><\/li><li id=\"ark-source-9\"><a href=\"https:\/\/tesla.arkmeds.com\/\">Arkmeds \u2014 Tesla guide: Android app operation and offline use.<\/a><\/li><li id=\"ark-source-10\"><a href=\"https:\/\/arkmeds.arkmeds.com.br\/solucoes\/analisadores-e-simuladores-stran-lab\/analisador-de-seguranca-eletrica-tesla\">Arkmeds \u2014 Tesla: digital delivery and client signature.<\/a><\/li><\/ol><p class=\"ark-credit\">By Thiago Bajur, CEO of Arkmeds. Published research, official scope summaries and an explicitly illustrative record template support this editorial article. Arkmeds manufactures Tesla; none of the cited research is presented as a Tesla evaluation. Source figures and data are credited at their point of use. <a href=\"https:\/\/creativecommons.org\/licenses\/by\/4.0\/\">CC BY 4.0<\/a>.<\/p><\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>What should you check before returning medical equipment to service? Compare IEC 62353 and IEC 60601-1, research findings and a practical release record.<\/p>\n","protected":false},"author":1,"featured_media":18352,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":true,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[63],"tags":[],"class_list":["post-18280","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-engineering"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Is repaired medical equipment ready for use? 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