NEMA HN 1 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
12-01-2013
14-10-2019
FOREWORD
CHANGES FROM PREVIOUS (2008) MDS[2] REVISION
Section 1 - GENERAL
1.1 Scope
1.2 References
1.3 Definitions
1.4 Acronyms
Section 2 - INSTRUCTIONS FOR OBTAINING, USING AND COMPLETING
MDS[2] FORM
2.1 Obtaining the MDS[2] Form (Providers)
2.2 Using the MDS[2] Form (Providers)
2.3 Completing the MDS[2] Form (Manufacturers)
Section 3 - MDS[2] FORM
Annex (Informative) - COMPARISON OF PREVIOUS (2008)
AND CURRENT (2013) MDS[2]
Aims at assisting professionals responsible for security risk assessment processes in their management of medical device security issues.
| DocumentType |
Standard
|
| PublisherName |
National Electrical Manufacturers Association
|
| Status |
Superseded
|
| SupersededBy |
| EN 82304-1:2017 | Health Software - Part 1: General requirements for product safety |
| AAMI/IEC TIR80001-2-8:2016 | 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 80001-2-2 |
| 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 |
| AAMI TIR57 : 2016 | PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT |
| BS EN 82304-1:2017 | Health Software General requirements for product safety |
| 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 |
| I.S. EN 82304-1:2017 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| 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 80001-2-2:2012 | 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 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |