AAMI TIR57 : 2016

Name: AAMI TIR57 : 2016
Brand: AAMI
Price: 282.00 USD

Superseded

View Superseded by

PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT

Available format(s)

Hardcopy , PDF

Superseded date

05-05-2020

Language(s)

English

Published date

01-01-2016

Publisher

Association for the Advancement of Medical Instrumentation

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

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

DocumentType	Standard
Pages	84
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	AAMI TIR57:2016(R2019)

ANSI/AAMI/IEC 80001-1:2010	APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
ISO/IEC 29147:2014	Information technology Security techniques Vulnerability disclosure
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
IEC TR 62443-3-1:2009	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 80001-2-8:2016	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 62443-2-1:2010	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 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 80001-2-2:2012	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
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)
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO/IEC 30111:2013	Information technology Security techniques Vulnerability handling processes