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Avis d'intention
Appareils électromédicaux – Partie 2-36: Exigences...
This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. The applicability of this Particular Standard is limited to components directly involved in the...
Avis d'intention
Appareils électromédicaux – Partie 2-58: Exigences...
Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated...
Avis d'intention
Appareils électromédicaux – Partie 2-62: Exigences...
This Standard applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH...
Avis d'intention
Appareils électromédicaux – Partie 2-63: Exigences...
This Standard applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular...
Avis d'intention
Appareils électromédicaux – Partie 2-64: Exigences...
This Standard applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the...
Avis d'intention
Appareils électromédicaux – Partie 2-65: Exigences...
This Standard applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly...
Avis d'intention
Appareils électromédicaux – Partie 2-68: Exigences...
The Standard applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of...
Avis d'intention
Appareils électromédicaux - Partie 2-69: Exigences...
This Standard specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen...
Avis d'intention
Appareils électromédicaux – Partie 1-3: Exigences...
1. Scope 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...
Avis d'intention
Appareils électromédicaux - Partie 1-6: Exigences...
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter...
Avis d'intention
Appareils électromédicaux - Partie 2-1: Exigences...
Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of...
Avis d'intention
Appareils électromédicaux – Partie 2-30: Exigences...
Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for...