Medical device book
A medical device book is a summarizing documentation of all data of an energetically operated medical device of Annex 1 or 2 , which according to § 12 of the MPBetreibV ( Medical Device Operator Ordinance ) must be kept by every operator.
In addition to information on the operator, inventory number, serial number, functional test, test data, results of prescribed safety and metrological controls, it must also contain the date of instruction and the names of the instructed persons as well as data on maintenance. If necessary, malfunctions and repeated operating errors of the same type as well as messages about possible occurrences are documented. For the information, the designation according to the nomenclature for medical devices published by the German Institute for Medical Documentation and Information (DIMDI) should be used. For electronic clinical thermometers as compact thermometers and blood pressure measuring devices with mercury or aneroid manometers for non-invasive measurements, no medical device book has to be kept.
The medical device book must be accessible to users during working hours. It must be kept for at least five years after the medical device concerned has been taken out of service. Upon request, the competent authority is to be granted access to the medical device books at any time.
Individual evidence
- ↑ MPBetreibV § 12 on gesetze-im-internet.de ; accessed on January 14, 2019