Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

19-05-2016

Publisher

International Electrotechnical Committee

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Guidance for establishing SECURITY CAPABILITIES
Bibliography

IEC TR 80001-2-8:2016, which is a Technical Report, provides guidance to Health Delivery Organizations (HDOs) and Medical Device Manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001-2-2.

DevelopmentNote	Stability date: 2018. (05/2016)
DocumentType	Technical Report
Pages	51
PublisherName	International Electrotechnical Committee
Status	Current

Standards	Relationship
AAMI/IEC TIR80001-2-8:2016	Identical
NEN NPR IEC/TR 80001-2-8 : 2016	Identical
PD IEC/TR 80001-2-8:2016	Identical

AAMI TIR57 : 2016	PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
PD IEC/TR 80001-2-9:2017	Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
AAMI TIR57:2016(R2023)	Principles for medical device security—Risk management

IEC 80001-1:2010	Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO/IEC 15408-2:2008	Information technology — Security techniques — Evaluation criteria for IT security — Part 2: Security functional components
ISO/IEC 27001:2013	Information technology — Security techniques — Information security management systems — Requirements
NEMA HN 1 : 2013	MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
IEC TS 62443-1-1:2009	Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
ISO/IEC 15408-3:2008	Information technology — Security techniques — Evaluation criteria for IT security — Part 3: Security assurance components
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 TR 80001-2-3:2012	Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
ISO 27799:2016	Health informatics Information security management in health using ISO/IEC 27002

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IEC TR 80001-2-8:2016

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