09/30157835 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO/IEC 80001-1 - APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
Hardcopy , PDF
30-04-2011
English
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FOREWORD
INTRODUCTION
1 Scope
1.1 Purpose
1.2 Field of application
2 Terms and Definitions
3 Roles and responsibilities
3.1 General
3.2 RESPONSIBLE ORGANIZATION
3.3 TOP MANAGEMENT
3.4 MEDICAL IT-NETWORK RISK MANAGER
3.5 MEDICAL DEVICE manufacturer(s)
3.6 Other providers of information technology
4 Life cycle RISK MANAGEMENT in MEDICAL
IT-NETWORKS
4.1 Overview
4.2 RESPONSIBLE ORGANIZATION RISK MANAGEMENT
4.3 MEDICAL IT-NETWORK RISK MANAGEMENT
Planning and Documentation
4.4 CHANGE-RELEASE MANAGEMENT and CONFIGURATION
MANAGEMENT
4.5 Live Network RISK MANAGEMENT
5 Document control
5.1 Document control procedure
5.2 MEDICAL IT-NETWORK RISK MANAGEMENT FILE
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
Information technology - Service management
Annex E - Bibliography
BS EN ISO/IEC 80001-1
| Committee |
CH/62/1
|
| DocumentType |
Draft
|
| Pages |
37
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO/IEC 15026:1998 | Information technology System and software integrity levels |
| 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/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 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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