What is BS EN 62570 - Standard practice for marking medical devices about?
BS EN 62570 is an international standard that focuses on standard practice for marking medical devices and safety in the magnetic resonance environment. BS EN 62570 specifies the permanent marking of items, which are used in an MR environment, using terms and icons. BS EN 62570 to the practice of marking items that might be used in the magnetic resonance (MR) environment.
Note- BS EN 62570 does not purport to address all the safety concerns, if any, associated with its use. It is the responsibility of the user of his standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations before use.
Who is BS EN 62570 - Standard practice for marking medical devices for?
BS EN 62570 on standard practice for marking medical devices and safety in the magnetic resonance environment is useful for:
- Research and Development team
- Medical device manufacturing companies
- Governing authorities
- Medical laboratories
Why should you use BS EN 62570 - Standard practice for marking medical devices?
Medical devices and other items vary widely in size, and the amount of information that practically can be included in marking varies accordingly. For implants, the MR marking shall be included in the labelling (including the instructions for use, package inserts, patient, and physician manuals) and on the patient information card. The purpose of BS EN 62570 is to recommend that items that may be brought into the MR environment be permanently marked to indicate the MR environment to which a specific item may safely be exposed and recommend that items that may be brought into the MR environment be permanently marked to indicate the MR environment to which a specific item may safely be exposed.
It is recognized that direct marking on the item is not practical for implants and certain other medical devices. Where direct marking is not practical, BS EN 62570 recommends that the marking be included in the labelling and on patient information cards