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Standards Referenced in AAMI TIR38

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AAMI 14971 7th Edition, 2007
Medical devices—Application of risk management to medical devices
Includes all amendments and changes through Reaffirmation Notice , 2010

AAMI 14971

7th Edition, 2007

Complete Document
 
Medical devices—Application of risk management to medical devices
Includes all amendments and changes through Reaffirmation Notice , 2010
Additional Comments:
SAME AS ISO 14971
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AAMI 62304 6th Edition, 2006
Medical device software - Software life cycle processes
Includes all amendments and changes through Amendment 1, 2016

AAMI 62304

6th Edition, 2006

Complete Document
 
Medical device software - Software life cycle processes
Includes all amendments and changes through Amendment 1, 2016
Additional Comments:
CUSTOMER MUST GO DIRECT TO AAMI TO PURCHASE
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ASTM F2761 2009 Edition, 2009
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
Includes all amendments and changes through Reapproval Notice , 2013

ASTM F2761

2009 Edition, 2009

Complete Document
 
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
Includes all amendments and changes through Reapproval Notice , 2013
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IEC/TR 80001-2-2 1st Edition, July 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 80001-2-2

1st Edition, July 2012

Complete Document
 
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
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IEC TR 80001-2-9 1st Edition, January 2017
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

IEC TR 80001-2-9

1st Edition, January 2017

Complete Document
 
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
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IEC/TR 80002-1 1st Edition, September 2009
Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software

IEC/TR 80002-1

1st Edition, September 2009

Complete Document
 
Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
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ISO DIS 14971 2018 Edition, July 19, 2018
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

ISO DIS 14971

2018 Edition, July 19, 2018

Complete Document
 
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
Additional Comments:
NOW A FINAL DRAFT * SEE ISO FDIS 14971
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ISO/IEC 15026-2 1st Edition, February 15, 2011
Systems and software engineering - Systems and software assurance - Part 2: Assurance case

ISO/IEC 15026-2

1st Edition, February 15, 2011

Complete Document
 
Systems and software engineering - Systems and software assurance - Part 2: Assurance case
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Additional Comments:
ENGLISH
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ISO/IEC DIS 15026-1 2018 Edition, February 1, 2018
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
Includes all amendments and changes through Draft , February 1, 2018

ISO/IEC DIS 15026-1

2018 Edition, February 1, 2018

Complete Document
 
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
Includes all amendments and changes through Draft , February 1, 2018
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Additional Comments:
SEE ISO/IEC DIS 15026-1
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ISO/IEC/IEEE 15026-1 1st Edition, March 2019
Systems and software engineering — Systems and software assurance — Part 1: Concepts and vocabulary

ISO/IEC/IEEE 15026-1

1st Edition, March 2019

Complete Document
 
Systems and software engineering — Systems and software assurance — Part 1: Concepts and vocabulary
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Additional Comments:
ENGLISH
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