GSO IEC 60601-1-2:2015

Gulf Standard   Current Edition
· Approved on 21 December 2015 ·

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

GSO IEC 60601-1-2:2015 Files

GSO IEC 60601-1-2:2015 Scope

IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments; - specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; - specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; - specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and - better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions: - guidance for determination of immunity test levels for special environments; - guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; - guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and - guidance on identification of immunity pass/fail criteria.

Best Sellers From Health Sector

BH GSO 1943:2022
GSO 1943:2021 
Bahraini Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 1943:2021
 
Gulf Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023 
Bahraini Standard
Personal Care and Baby Wet Wipes

Recently Published from Health Sector

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 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 17069:2024
ISO 17069:2020 
Gulf Standard
Accessible design — Consideration and assistive products for accessible meeting