Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment,
where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten

Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnostic

Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zaščita pred sevanjem pri rentgenski diagnostični opremi - Dopolnilo A1 (IEC 60601-1-3:2008/A1:2013) - Popravek

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEM). Ta spremljevalni standard se uporablja za RENTGENSKO OPREMO in podsestave tovrstne opreme,
kadar se RADIOLOŠKE SLIKE človeških PACIENTOV uporabljajo za diagnosticiranje, načrtovanje ali usmerjanje medicinskih postopkov.

General Information

Status
Published
Publication Date
08-May-2014
Current Stage
6060 - Document made available - Publishing
Start Date
09-May-2014
Completion Date
09-May-2014

Relations

Effective Date
29-Jan-2023
Corrigendum

EN 60601-1-3:2008/A1:2014/AC:2014

English language
1 pages
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Frequently Asked Questions

EN 60601-1-3:2008/A1:2013/AC:2014 is a corrigendum published by CLC. Its full title is "Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment". This standard covers: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

EN 60601-1-3:2008/A1:2013/AC:2014 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 13.280 - Radiation protection. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 60601-1-3:2008/A1:2013/AC:2014 has the following relationships with other standards: It is inter standard links to EN 60601-1-3:2008/A1:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-1-3:2008/A1:2013/AC:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN 60601-1-3:2008/A1:2013/AC:2014 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen RöntgengerätenAppareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnosticMedical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - C
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