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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.
On Rehabilitation Robotics Safety, Benchmarking, and Standards
Published in Paolo Barattini, Vicentini Federico, Gurvinder Singh Virk, Tamás Haidegger, Human–Robot Interaction, 2019
Product standards are related to a specific product or group of products. They include: Standards that state safety or performance parameters and include reference test methods that can be used to demonstrate conformity to those parameters, (e.g., IEC 60601-1 and the associated supplementary standards and special specifications for medical electrical devices).IEC 60601-1 Medical Electrical Equipment; Part 1: “General requirements for basic safety and essential performance” is the key standard for all medical devices which are a medical electrical equipment or system. In the IEC 60601-1 series, other specific “collateral” standards are included which have a specific focus like usability engineering and apply for all medical electrical equipment or systems for which this focus is relevant. Details are shown in 13.2.2 “Standards for Medical Electrical Devices for Neurorehabilitation.”In some cases, international standard organizations write additional technical reports for specific standards to give the user of the standards more background information and guidance on how to use the specific standard. IEC publishes their technical reports regarding the IEC 60601 series in the IEC 60601-4-x format.Disclosure and test method standards where adherence to declared pass/fail criteria is necessary to demonstrate safety and performance of medical devices.
Safety Standards and Certification
Published in Chris Hobbs, Embedded Software Development for Safety-Critical Systems, 2017
As illustrated in Figure 3.4, IEC 62304 specializes IEC 60601 for software and incorporates ISO 14971 (“Medical devices — Application of risk management to medical devices”) to provide the hazard and risk identification and management process. This involves identifying hazards and risks, evaluating their severity, controlling them where necessary, and continuing to monitor the risks during the product’s life. Generally, much of this information would be contained in a hazard and risk analysis — see page 56.
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.’