Beschriftung und Kennzeichnung von medizinischen Geräten
Leonard Eisner, Robert M. Brown und Dan Modi haben auf dem Informationsportal Medical Device Link eine kurze Einführung in den amerikanischen Standard zur Beschriftung und Kennzeichnung von medizinischen Geräten veröffentlicht:
IEC 60601-1 treats labeling as a critical component of the device and provides comprehensive requirements for marking and labeling. The standard requires all information for safe installation, use, storage, servicing, and maintenance of the device to be provided to the user. For safety-significant items and for effective use of the device, the standard requires that markings be placed directly on the device. Symbols are often preferred over wording to meet such marking requirements.
Many of the requirements for IEC 60601-1 also support compliance to various national regulations for medical devices. However, defining a medical device’s target market prior to deciding the marking and labeling program saves medical manufacturers both time and money. Once the target market is established, it is much easier to identify the proper national regulations that apply in addition to IEC 60601-1 tests. Then a test suite can be defined, and labeling can be selected that incorporates all requirements.