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Тезис Предпросмотр

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), 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 (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.


Общая информация

  • Текущий статус :  Published
    Дата публикации : 2010-10
  • Версия : 1
    Число страниц : 70
  • :
    ISO/TC 215
    Health informatics
  • 11.040.01
    Medical equipment in general
    35.240.80
    IT applications in health care technology

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Формат Язык
Бумажный
  • CHF240

Жизненны цикл

Стандарт, который пересматривается каждые 5 лет



Изменения / Исправления

  • Сейчас на стадии пересмотра
    IEC 80001-1:2010
  • Будет заменено
    IEC/DIS 80001-1

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