Monday, May 15, 2017

New Medical Equipment Standards for the 1st Quarter 2017

Document Center, Inc. is pleased to announce that the following Standards on Medical Equipment in General are now available;

  •  BS EN 80601-2-35, 2009 Edition with Amendment 1, Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
  • BS EN ISO 13485, 2016 Edition with Corrigendum 2, Medical devices. Quality management systems. Requirements for regulatory purposes
  • IEC 80001-2-9, Edition 1.0, 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
  • SIS EN ISO 13485, Corrigendum 1 for 2016 Edition, Medical devices - Quality management systems - Requirements for regulatory purposes

For more standards like these, please refer to our Document Center List of Standards on Medical Equipment in General.