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NEN-EN-IEC 60601-2-63/A1

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

active
Organization: NEN
Publication Date: 1 November 2019
Status: active
Page Count: 22
ICS Code (Radiographic equipment): 11.040.50
scope:

Scope, object and related standards

1 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Collateral standards

IEC 60601-1-8, IEC 60601-1-101, IEC 60601-1-112 and IEC 60601-1-123 do not apply

1 IEC 60601-1-10, 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

2 IEC 60601-1-11, 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

3 IEC 60601-1-12, 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

Document History

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
NOTE 1 An example of such equipment is an equipment designed to perform PANORAMIC, CEPHALOMETRIC and DENTAL VOLUMETRIC RECONSTRUCTION (hereafter DVR) as defined in 201.3.203. DENTAL EXTRA-ORAL X-RAY...
NEN-EN-IEC 60601-2-63/A1
November 1, 2019
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Scope, object and related standards 1 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and...
June 1, 2015
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
NEN-EN-IEC 60601-2-63 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...

References

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