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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 032 Date of Recognition 08/06/2013 
FR Recognition Number 13-38
Standard
IEC 80001-1 Edition 1.0 2010-10
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
U.S. Identical Adoption
ANSI AAMI IEC 80001-1:2010
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
Scope/Abstract
Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), this international standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). This international standard does not specify acceptable risk levels....

This standard applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network....

This standard applies throughout the life cycle of IT-networks incorporating medical devices....

This standard applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device....

This standard applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization.

This standard does not apply to personal use applications where the patient, operator and responsible organization are one and the same person....

This standard does not address regulatory or legal requirements.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Any procode which describes a networkable medical device
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Brian Fitzgerald
  FDA/OMPT/CDRH/OSEL/
  301-796-2579
  brian.fitzgerald@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Software/Informatics
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