GSO IEC 80001-1:2024
GSO IEC 80001-1:2013
IEC 80001-1:2021
Gulf Standard
·
English
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Prepared By
QGOSM
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
تطبيق إدارة المخاطر لشبكات تكنولوجيا المعلومات التي تتضمن الأجهزة الطبية الجزء 1: السلامة والفعالية والأمان في تنفيذ واستخدام الأجهزة الطبية المتصلة أو البرامج الصحية المتصلة
Project is completed and standards documents are published.
GSO IEC 80001-1:2024
Current Edition
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
View in Standards Store
Basic Details
Related Standards
Health Sector
Proposed and Prepared by
QGOSM
International Classification of Standards (ICS)
35.240.80
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IT applications in health care technology
11.040.01
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Medical equipment in general
Project Scope
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.
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.
تحدد IEC 80001-1:2021 المتطلبات العامة للمؤسسات في
تطبيق إدارة المخاطر قبل وأثناء وبعد توصيل نظام تكنولوجيا المعلومات الصحية داخل
البنية التحتية لتكنولوجيا المعلومات الصحية، من خلال معالجة الخصائص الرئيسية
للسلامة والفعالية والأمن مع إشراك أصحاب المصلحة المناسبين.
IEC 80001-1:2021 يلغي ويحل محل الطبعة الأولى المنشورة في عام 2010. وتشكل هذه
الطبعة مراجعة فنية.
تتضمن هذه الطبعة التغييرات الفنية الهامة التالية فيما يتعلق بالإصدار
السابق:
أ) تم تغيير الهيكل ليتوافق بشكل أفضل مع ISO 31000؛
ب) تحديد متطلبات المنظمة في تطبيق إدارة المخاطر؛
ج) إيصال قيمة ونية وغرض إدارة المخاطر من خلال المبادئ التي تدعم الحفاظ على
الخصائص الرئيسية أثناء تنفيذ واستخدام البرامج الصحية المتصلة و/أو أنظمة
تكنولوجيا المعلومات الصحية