IEC 80001-1 PDF

Interoperability is increasingly required. This standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security. This standard applies after the product on the market was placed on the market for the first time if one or more medical device s has have been purchased by the responsible organization and is are intended to be incorporated into IT-networks. This standard applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device.

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Interoperability is increasingly required. This standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security. This standard applies after the product on the market was placed on the market for the first time if one or more medical device s has have been purchased by the responsible organization and is are intended to be incorporated into IT-networks.

This standard applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. The standard is directed at responsible organizations, medical device manufacturers and providers of other information technology. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.

The interpretation of the requirements, in particular of clauses 3. In this connection, an essential question is the agreement on duty to deliver and duty to collect for the provision and definition of "important updated information".

This standard does not address regulatory or legal requirements. The responsible subcommittee is UK Cooperation at DIN.

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Zwar ist der Text weitgehend nachvollziehbar und er formuliert Forderungen, denen ich zustimmen kann. Keine Checklisten, keine Anleitung wie man konkret zu verfahren hat. Mehr zu diesem Thema finden Sie weiter unten. Bleibt zu hoffen, dass an diesem Entwurf doch noch etwas verbessert wird.

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