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APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
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Available format(s): Hardcopy, PDF
Superseded date: 17-11-2021
Language(s): English
Published date: 01-01-2011
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
FOREWORDINTRODUCTION1 Scope2 Terms and definitions3 Roles and responsibilities4 Life cycle RISK MANAGEMENT in MEDICAL IT-NETWORKS5 Document controlAnnex A (informative) - RationaleAnnex B (informative) - Overview of RISK MANAGEMENT relationshipsAnnex C (informative) - Guidance on field of applicationAnnex D (informative) - Relationship with ISO/IEC 20000-2:2005 Information technology - Service management - Part 2: Code of practiceBibliography
Describes 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).
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