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ANSI/AAMI/IEC TIR80001-2-1:2012

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

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
76
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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