Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão

[Marcelo]

ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The group finalized the discussion on the comments of ISO TR 24971 (with only a couple of comments awaiting discussion in the next weeks) and it is expected to circulate ISO TR 24971 together or a little after the circulation of the FDIS of ISO 14971.

The plan is to finish the work at the London ISO TC 210 meeting in October.

ISO 14971 is expected to be published in November, and ISO TR 24971, some two months later.

O ISO TC 210 JWG 1 reuniu-se na semana passada em Estocolmo para discutir os últimos passos da revisão da ISO 14971 e ISO 24971. O grupo finalizou a discussão sobre os comentários da ISO TR 24971 (com apenas alguns comentários aguardando discussão nas próximas semanas ) e espera-se que circule o ISO TR 24971 em conjunto ou um pouco depois da circulação do FDIS da ISO 14971.

O plano é concluir o trabalho na reunião ISO ISO 210 da London em outubro.

Espera-se que a ISO 14971 seja publicada em novembro e a ISO TR 24971, cerca de dois meses depois.

Posted at Marcelo's Medicaldevice.expert website...

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[Sidney Vianna]

From Reducing the risks of medical devices: international guidance just updated

ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.
Primarily intended for medical device manufacturers, the ISO standard promotes the safety of devices and equipment used for medical purposes. It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment. The standard was updated to better align with changes in medical device regulations around the world.
The ISO 14971 revision was aimed at clarifying the standard’s technical requirements by including more detailed information on the steps manufacturers must take to meet those requirements. It also includes new and updated terminology to reflect the current market needs. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel.