AAMI TIR57 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
Hardcopy , PDF
05-05-2020
English
01-01-2016
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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Superseded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 |
| 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 |
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