Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number	032	Date of Entry 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
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* Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact  Brian Fitzgerald   FDA/OC/CDRH/OSPTI/DAHRSSP/   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
*These are provided as examples and others may be applicable.