This standard specifies requirements for all entities involved in medical devices, in all stages of the product life cycle: from design to manufacture to installation to disposal. Ubora Platform is structured to be a guideline for design activities in compliance to this standard.
This standard specifies requirements for designers and manufacturers of medical devices, in order to minimize the risk of the device itself. There is no “risk zero” device but many activities can be implemented to reduce and manage risk. This standard provides useful checklists and also guidance on the most widespread risk management techniques such as FMEA.
This guideline provides information on methods used to assess the clinical performance and the clinical benefit of a medical device.
This standard provides guidance on how to manage the human factors while designing a medical device (usability engineering).
This standard lists a series of symbols that may be applicable in labels of medical devices.
ISO 11199-2:2005 specifies requirements and methods of testing the static stability braking capabilities, static strength and fatigue of rollators being used as walking aids with wheels, manipulated by the hands, without accessories, unless specified in the particular test procedure. ISO 11199-2:2005 also gives requirements relating to safety, ergonomics, performance, and information supplied by the manufacturer including marking and labelling. The requirements and tests are based on every-day usage of rollators as walking aids, for a maximum user mass as specified by the manufacturer. ISO 11199-2:2005 includes rollators specified for a user mass of no less than 35 kg. ISO 11199-2:2005 is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.