AAMI TIR57 : 2016

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT

Publisher: Association for the Advancement of Medical Instrumentation

Published:

Available Formats: PDF - English - DRM, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Terms and definitions
3 General guidance for performing security risk management
4 Security risk analysis
5 Security risk evaluation
6 Risk control
7 Evaluation of overall residual security risk acceptability
8 Security risk management report
9 Production and post-production information
Annex A (informative) - Security engineering principles and
        nomenclature
Annex B (informative) - Security risk assessment
Annex C (informative) - Generating cybersecurity requirements
Annex D (informative) - Questions that can be used to identify
        medical device security characteristics
Annex E (informative) - Security risk examples applied to a
        medical device
Annex F (informative) - A comparison of terminology between key
        referenced standards
Bibliography

Abstract - (Show below) - (Hide below)

Gives guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.

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Published
Document Type	Standard
Status	Superseded
Publisher	Association for the Advancement of Medical Instrumentation
Pages
ISBN
Superseded By	AAMI TIR57 : 2016(R2019)

Standards Referencing This Book - (Show below) - (Hide below)

AAMI IEC 80001-1 : 2010	APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
NEMA HN 1 : 2013	MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
AAMI ES60601-1 : 2005	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
ISO/IEC 29147 : 2014	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - VULNERABILITY DISCLOSURE
IEC TS 62443-1-1 : 1.0 : 2009	INDUSTRIAL COMMUNICATION NETWORKS - NETWORK AND SYSTEM SECURITY - PART 1-1: TERMINOLOGY, CONCEPTS AND MODELS
IEC TR 62443-3-1 : 1.0	INDUSTRIAL COMMUNICATION NETWORKS - NETWORK AND SYSTEM SECURITY - PART 3-1: SECURITY TECHNOLOGIES FOR INDUSTRIAL AUTOMATION AND CONTROL SYSTEMS
CFR 45(PTS1-199) : OCT 2017	PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
IEC TR 80001-2-8 : 1ED 2016	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
IEC 62443-2-1 : 1.0 : 2010	INDUSTRIAL COMMUNICATION NETWORKS - NETWORK AND SYSTEM SECURITY - PART 2-1: ESTABLISHING AN INDUSTRIAL AUTOMATION AND CONTROL SYSTEM SECURITY PROGRAM
FIPS PUB 140-2 : 0	SECURITY REQUIREMENTS FOR CRYPTOGRAPHIC MODULES
AAMI ISO TIR 24971 : 2013	MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971
AAMI IEC TIR 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
AAMI IEC 62366-1 : 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
IEC TR 80001-2-2 : 1.0	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
ISO/IEC GUIDE 51 : 2014	SAFETY ASPECTS - GUIDELINES FOR THEIR INCLUSION IN STANDARDS
ISO/IEC 27005 : 2011	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY RISK MANAGEMENT
FIPS PUB 185 : 0	ESCROWED ENCRYPTION STANDARD (EES)
IEC 62443-3-3 : 2013 COR 1 2014	INDUSTRIAL COMMUNICATION NETWORKS - NETWORK AND SYSTEM SECURITY - PART 3-3: SYSTEM SECURITY REQUIREMENTS AND SECURITY LEVELS
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
AAMI ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO/IEC 30111 : 2013	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - VULNERABILITY HANDLING PROCESSES

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