OS GSO IEC 60601-1-6:2015
IEC 60601-1-6:2010
Omani Standard
Current Edition
·
Approved on
21 December 2015
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
OS GSO IEC 60601-1-6:2015 Files
No files are available for this standard right now!
OS GSO IEC 60601-1-6:2015 Scope
IEC 60601-1-6:2010+A1:2013 specifies a process for a manufacturer toanalyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. This consolidated version consists of the third edition (2010) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.
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 2063:2023
Gulf Standard
Cosmetic Products - Hair Conditioner (Balsam)
GSO 1223:2023
Gulf Standard
Cosmetic Products-Deodorants
Recently Published from Health Sector
GSO ISO 11608-7:2024
ISO 11608-7:2016
Gulf Standard
Needle-based injection systems for medical use
— Requirements and test methods
— Part 7: Accessibility for persons with visual impairment
GSO ISO/TR 24666:2024
ISO/TR 24666:2023
Gulf Standard
Sports and recreational facilities
— Probes for entrapment/entanglement on playground equipment
— Collection of data
GSO ISO 9713:2024
ISO 9713:2022
Gulf Standard
Neurosurgical implants
— Self-closing intracranial aneurysm clips
GSO ISO/TS 22690:2024
ISO/TS 22690:2021
Gulf Standard
Genomics informatics
— Reliability assessment criteria for high-throughput gene-expression data