IEC TR 80001-2-8:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
19-05-2016
01-10-2025
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.
| Committee |
TC 62/SC 62A
|
| DevelopmentNote |
Stability date: 2018. (05/2016)
|
| DocumentType |
Technical Report
|
| Pages |
51
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| 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 |
| DS 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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