IEC 80001-1:2010 Preview

Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), 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). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 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. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.


General information

  • Current status : Published
    Publication date : 2010-10
  • Edition : 1
    Number of pages : 70
  • :
    ISO/TC 215
    Health informatics
  • 11.040.01
    Medical equipment in general
    35.240.80
    IT applications in health care technology

Buy this standard

Format Language
Paper
PDF
  • CHF198

Got a question?

Check out our FAQs


Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)