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Design inputs: Part II
Published in Marie B. Teixeira, Design Controls for the Medical Device Industry, 2019
There are a number of safety and performance standards that are available, depending on your device, that provide basic requirements that should be considered when designing and developing your device. For example: ISO 5356—Specifies dimensional and gauging requirements for cones and sockets intended for connecting anesthetic and respiratory equipment, e.g., in breathing systems, anesthetic-gas scavenging systems, and vaporizers.EN 60601-1—Basic safety and essential performance requirements for devices or components that qualify as medical electrical equipment.IEC 62304—Medical device software. Software life-cycle processes.
Usability engineering in practice: developing an intervention for post-stroke therapy during a global pandemic
Published in Journal of Medical Engineering & Technology, 2022
Avril D. McCarthy, Louise Moody, Mark L. Reeves, T. Jamie Healey, Tim Good, Lise Sproson, Adewale Adebajo, Wendy Tindale, Krishnan Padmakumari Sivaraman Nair
Table 1 outlines some of the UK, European and International standards and recommendations relating to medical devices, risk management, electrical safety and human factors engineering – areas that are commonly intertwined in ensuring safe and acceptable device usability. Within Table 1 the ISO 14971 standard [8] relates to risk management and this should be applied during the life cycle of all forms of medical device. Depending on whether the device is electrically powered and/or employs software, will also influence the selection and use of other specific standards highlighted in Table 1 such as the IEC 60601 family for medical electrical equipment or IEC 62304 [11] for medical device software. IEC 62366 [10] relates specifically to medical device usability during normal usage. However, IEC 60601-1-6 [12], which also focuses on usability, may be more appropriate to employ when developing electrical medical devices. The context of usage is also important, and within the 60601 family is 60601-1-11 [13], which focuses on intended medical device use in the home environment. Again referenced in Table 1, the UK’s medical device regulator (the MHRA), the European Commission and the American National Standards Institute (ANSI) have provided guidance, recommendations and updated medical device regulations centring on usability engineering and human factors. Thus reflecting the importance of achieving effective usability to reduce user risk and deliver safe devices able to meet regulatory compliance requirements.
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.’