ANSI/AAMI/IEC TIR80001-2-1:2012
Current
The latest, up-to-date edition.
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
English
30-09-2012
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC/TR 80001-2-1:2012
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Prerequisites
5 Study of terms used in RISK MANAGEMENT
6 The steps
7 IEC 80001-1:2010, Subclause 4.4: Step by step
8 Practical examples
Annex A (informative) - Common HAZARDS, HAZARDOUS SITUATIONS,
and causes to consider in MEDICAL IT-NETWORKS
Annex B (informative) - List of questions to consider
when identifying HAZARDs of the MEDICAL IT-NETWORK
Annex C (informative) - Layers of MEDICAL IT-NETWORKS
where errors can be found
Annex D (informative) - Probability, severity, and RISK
acceptability scales used in the examples in this
technical report
Annex E (informative) - MONITORING RISK mitigation
effectiveness
Annex F (informative) - RISK ANALYZING small changes
in a MEDICAL IT-NETWORK
Annex G (informative) - Example of Change Window Form
Annex H (informative) - Template for examples
Bibliography
Specifies step-by-step information to aid RESPONSIBLE ORGANIZATIONS in implementation of the RISK MANAGEMENT PROCESS required by IEC 80001-1.
| Committee |
IT
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-454-8
|
| Pages |
68
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| IEC TR 80001-2-1:2012 | Identical |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/TS 19218-2:2012 | Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes |
| ISO/IEC 27002:2013 | Information technology — Security techniques — Code of practice for information security controls |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC TR 80001-2-3:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 27799:2016 | Health informatics — Information security management in health using ISO/IEC 27002 |
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