OS GSO IEC 60601-2-65:2017

Omani Standard   Current Edition
· Approved on 03 October 2017 ·

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Radiographic equipment
Including radiographic diagnostic and therapy equipment

OS GSO IEC 60601-2-65:2017 Files

OS GSO IEC 60601-2-65:2017 Scope

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT. The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY. DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY MONOBLOCK ASSEMBLY. Therefore in this particular standard the concept of X-RAY TUBE ASSEMBLY is replaced by that of X-RAY MONOBLOCK ASSEMBLY. NOTE 2 Main components may be for instance the X-RAY MONOBLOCK ASSEMBLY and an ELECTRONIC X-RAY IMAGE RECEPTOR . NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard, since they have no electrical APPLIED PARTS in the PATIENT ENVIRONMENT, and are not ME EQUIPMENT. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. NOTE 4 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or in this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL INTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard.

Best Sellers From Electrical Sector

GSO 2530:2016
 
Gulf Standard
Energy Labelling And Minimum Energy Performance Requirements For Air-Conditioners
OS GSO 2530:2016
GSO 2530:2016 
Omani Standard
Energy Labelling And Minimum Energy Performance Requirements For Air-Conditioners
OS GSO 34:2007
GSO 34:2007 
Omani Standard
LEAD-ACID STARTER BATTERIES USED FOR MOTOR VEHICLES AND INTERNAL COMBUSTION ENGINES
GSO 34:2007
 
Gulf Technical Regulation
LEAD-ACID STARTER BATTERIES USED FOR MOTOR VEHICLES AND INTERNAL COMBUSTION ENGINES

Recently Published from Electrical Sector

GSO IEC 60350-2:2024
IEC 60350-2:2017 
Gulf Standard
Household electric cooking appliances - Part 2: Hobs - Methods for measuring performance
GSO IEC 60332-3-25:2024
IEC 60332-3-25:2018 
Gulf Standard
Tests on electric and optical fibre cables under fire conditions - Part 3-25: Test for vertical flame spread of vertically-mounted bunched wires or cables - Category D
GSO IEC 62841-3-6:2024
IEC 62841-3-6:2014 
Gulf Standard
Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery - Safety - Part 3-6: Particular requirements for transportable diamond drills with liquid system
GSO IEC 60335-2-119:2024
IEC 60335-2-119:2021 
Gulf Standard
Household and similar electrical appliances - Safety - Part 2-119: Particular requirements for commercial vacuum packaging appliances