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GSO IEC TS 60601-4-6:2025
IEC TS 60601-4-6:2024
Gulf Standard
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
ISO 15223-1:2021/Amd 1:2025
Amendment to International Standard
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
ISO/TS 4452:2025
International Standard
Specification and demonstration of system reliability of single-use drug delivery systems
BH GSO IEC 80001-1:2024
IEC 80001-1:2021
Bahraini Standard
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
BH GSO ISO 15378:2024
ISO 15378:2017
Bahraini Standard
Primary packaging materials for medicinal products
— Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
BH GSO IEC 60601-2-35:2024
IEC 60601-2-35:2020
Bahraini Standard
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
GSO IEC 80001-1:2024
IEC 80001-1:2021
Gulf Standard
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
GSO IEC 60601-2-35:2024
IEC 60601-2-35:2020
Gulf Standard
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
BH GSO IEC 60601-1-8:2024
IEC 60601-1-8:2006
Bahraini Standard
Medical electrical equipment – Part 1-8: General requirements for safety – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
GSO ISO 15378:2024
ISO 15378:2017
Gulf Standard
Primary packaging materials for medicinal products
— Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
BH GSO ISO/TR 24971:2024
ISO/TR 24971:2020
Bahraini Standard
Medical devices
— Guidance on the application of ISO 14971
BH GSO ISO 14971:2024
ISO 14971:2019
Bahraini Standard
Medical devices
— Application of risk management to medical devices