OS GSO IEC 60601-2-64:2017
Omani Standard
Current Edition
·
Approved on
03 October 2017
·
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
OS GSO IEC 60601-2-64:2017 Files
No files are available for this standard right now!
OS GSO IEC 60601-2-64:2017 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, and
– intended to be
– for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
– subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION’S premises.
NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).
NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their zero positions and the direction of movement with increasing value (see 201.7.4.101).
Best Sellers From Electrical Sector
GSO 2530:2016
Gulf Standard
Energy Labelling And Minimum Energy Performance Requirements For Air-Conditioners
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
OS GSO 2530:2016
GSO 2530:2016
Omani Standard
Energy Labelling And Minimum Energy Performance Requirements For Air-Conditioners
![OS Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_os_sml.png)
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
OS GSO 34:2007
GSO 34:2007
Omani Standard
LEAD-ACID STARTER BATTERIES USED FOR
MOTOR VEHICLES AND INTERNAL
COMBUSTION ENGINES
![OS Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_os_sml.png)
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
GSO 34:2007
Gulf Technical Regulation
LEAD-ACID STARTER BATTERIES USED FOR
MOTOR VEHICLES AND INTERNAL
COMBUSTION ENGINES
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
Recently Published from Electrical Sector
GSO IEC 63296-1:2024
IEC 63296-1:2021
Gulf Standard
Portable multimedia equipment - Determination of battery duration - Part 1: Powered loudspeaker equipment
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
![IEC Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_iec_sml.png)
GSO IEC 61558-2-4:2024
IEC 61558-2-4:2021
Gulf Standard
Safety of transformers, reactors, power supply units and combinations thereof - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers for general applications
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
![IEC Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_iec_sml.png)
GSO IEC 60335-2-23:2024
IEC 60335-2-23:2016
Gulf Standard
Household and similar electrical appliances - Safety - Part 2-23: Particular requirements for appliances for skin or hair care
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
![IEC Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_iec_sml.png)
GSO IEC 63174:2024
IEC 63174:2021
Gulf Standard
Electrically operated toothbrushes - Methods for measuring the performance
![GSO Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_gso_sml.png)
![IEC Standard](https://static.gso.org.sa/gso-uicore/assets/images/logo_iec_sml.png)