Please choose at least one filter
Published from
Time limit for review from
Withdrawn from
Released from
Guide to the development and inclusion of aspects of safety in international standards for medical devices
Information supplied by the manufacturer of medical devices
Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards:
Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
Medical devices – Quality management systems – Requirements for regulatory purposes
CE Harmonized
Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances
Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances
Medical device traceability enabled by unique device identification (UDI)
Medical devices – Application of risk management to medical devices (ISO 14971:2019)
Medical devices – Application of risk management to medical devices
You must be logged in to sign up for monitoring
You must be logged in to sign up for subscription
There is a problem adding monitoring - please try again later
There is a problem adding the subscription - please try again later
Du overvåger allerede dette emne
Du overvåger allerede denne standard
Er du sikker på at du vil overvåge dette emne?
Er du sikker på at du vil overvåge denne standard?
Du abonnerer allerede dette emne
Du abonnerer allerede denne standard
Er du sikker på at du vil abonnere på dette emne?
Er du sikker på at du vil abonnere på denne standard?
Du abonnerer nu på dette emne!
Du abonnerer nu på denne standard!
Activation of your subscription failed - please try again later or contact us
Du overvåger nu dette emne!
Du overvåger nu denne standard!
Activation of monitoring failed - please try again later or contact us
Are you sure you want to unsubscribe monitoring?
Are you sure you want to unsubscribe?
It was not possible to unsubscribe - please try again later or contact the Danish Standard
Please make sure you are logged in
Please choose number of devices you want to open the document on
The printed version is available at half price when you buy the electronic version
It is not possible to buy in the shop - please contact us