GSO IEC 60601-2-27:2015
Gulf Standard
Current Edition
·
Approved on
03 September 2015
·
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
GSO IEC 60601-2-27:2015 Files
No files are available for this standard right now!
You can buy this standard from any member store
GSO IEC 60601-2-27:2015 Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use.
This standard is not applicable to electrocardiographic monitors for home use. However,MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE.
Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2302:2022
Gulf Standard
Cosmetic Products – Face Masks
GSO 1223:2023
Gulf Standard
Cosmetic Products-Deodorants
Recently Published from Health Sector
GSO ISO 11608-6:2024
ISO 11608-6:2022
Gulf Standard
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
GSO ISO 16256:2024
ISO 16256:2021
Gulf Standard
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GSO ISO 14708-3:2024
ISO 14708-3:2017
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
GSO ISO 11978:2024
ISO 11978:2017
Gulf Standard
Ophthalmic optics — Contact lenses and contact lens care products — Labelling