CEI EN 80001-1 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
Hardcopy , PDF
English - Italian
01-01-2016
05-08-2022
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Superseded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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