Name: NEMA HN 1 : 2013
Brand: NEMA

NEMA HN 1 : 2013

Superseded

View Superseded by

MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY

Superseded date

10-14-2019

Published date

01-12-2013

Publisher

National Electrical Manufacturers Association

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Status	Superseded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	ANSI/NEMA HN 1:2019

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

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