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I.S. EN 80001-1:2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

17-11-2021

Language(s)

English

Published date

01-01-2011

Preview

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.

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).

DocumentType
Standard
Pages
46
PublisherName
National Standards Authority of Ireland
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Superseded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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