China 
Africa 
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On Rehabilitation Robotics Safety, Benchmarking, and Standards
Published in Paolo Barattini, Vicentini Federico, Gurvinder Singh Virk, Tamás Haidegger, Human–Robot Interaction, 2019
The IEC 60601 standards series defines safety requirements and essential performances for medical electrical devices and medical electrical systems. IEC 60601-1 is the general base standard, defining the basis for the basic safety and the essential performance characteristics of any medical electrical device and medical electrical system. For the user of this standard, it is important to know which version is accepted and in which country. The last published version is IEC 60601-1 Edition 3 with amendment 1 from 2012-08 (IEC 60601-1:2005+A1:2012). A small number of countries accept only the previous editions, while other countries have a longer transitory period for the new one. Additional to this situation, the user of standards should be aware of national deviations which occur quite often.
Medical Devices: IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
Risk management is intrinsically a part of the philosophy of the IEC in general and IEC 60601-1 in particular. In a unique approach, IEC 60601-1 integrates mandatory risk management principles of ISO 14971 but applies them to device instead of process certification. IEC 60601-1 facilitates compliance with legal and regulatory requirements specific to the healthcare area. It guides manufacturers in the identification of all hazards associated with a medical device, including for all operation modes and all fault scenarios. One outcome is a risk matrix that is associated with the use of an individual device. The probability of occurrence vs. severity of harm is classified. Anything significantly harmful and somewhat probable of occurring is addressed.
Prerequisites
Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022
For medical devices, the most relevant standard is: IEC 60601–1-3rd edition—Medical electrical equipment—Part 1: General requirements for basic safety and essential performance.
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
The IEC is a not-for-profit, quasi-governmental organization, founded in 1906. The IEC members are national committees, and they appoint experts and delegates from industry, government bodies, associations, and academia to participate in the technical and conformity assessment work of the IEC. The IEC has 104 TCs and defines the scope of each TC [23]. In the medical device industry, for example, IEC/TC 62 ‘Electrical equipment in medical practice’) is responsible for electrical equipment used in medical practice and develops many standards such as IEC 60601–1 ‘Medical electrical equipment – Part 1: General requirements for basic safety and essential performance’ and IEC 62304 ‘Medical device software – Software life-cycle processes.’