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IEC 80001-1:2021 ed2.0
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
75 стр.
Действует
Электронный (pdf)Печатная копия
335.78 CHF (включая НДС 20%)
Разработчик:
Зарубежные/IEC
ICS:
11.040.01 Medical equipment in general / Медицинское оборудование в целом, 35.240.80 IT applications in health care technology. Including computer tomography / Применение информационных технологий в здравоохранении. Включая компьютерную томографию
Описание
IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.
IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.