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CEI EN 80001-1 : 2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES

Available format(s)

Hardcopy , PDF

Superseded date

05-08-2022

Language(s)

English - Italian

Published date

01-01-2016

FOREWORD
INTRODUCTION
1 Scope
2 Terms and definitions
3 Roles and responsibilities
4 Life cycle RISK MANAGEMENT in MEDICAL
  IT-NETWORKS
5 Document control
Annex A (informative) - Rationale
Annex B (informative) - Overview of RISK MANAGEMENT
        relationships
Annex C (informative) - Guidance on field of application
Annex D (informative) - Relationship with ISO/IEC 20000-2:2005
        Information technology - Service management - Part 2:
        Code of practice
Bibliography

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).

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-233. (02/2012)
DocumentType
Standard
Pages
82
PublisherName
Comitato Elettrotecnico Italiano
Status
Superseded
SupersededBy

Standards Relationship
EN 80001-1:2011 Identical
IEC 80001-1:2010 Identical

ISO 16484-2:2004 Building automation and control systems (BACS) — Part 2: Hardware
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 31000:2009 Risk management Principles and guidelines
ISO/IEC 20000-1:2011 Information technology Service management Part 1: Service management system requirements
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO/IEC 20000-2:2012 Information technology Service management Part 2: Guidance on the application of service management systems
ISO/IEC 15026-2:2011 Systems and software engineering — Systems and software assurance — Part 2: Assurance case
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
IEC 61907:2009 Communication network dependability engineering
ISO 14971:2007 Medical devices Application of risk management to medical devices

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