Version control for medical anesthesia devices

摘要

A testing system, a testing process, a medical device, e.g., an anesthesia device (G), and a computer program product are provided for testing installed program versions for acceptability. The anesthesia device (G) comprises a plurality of electronic components (K), which are operated and/or controlled with a program, which may have various versions. A release function (50) is activated for releasing the anesthesia device (G) or for putting same into operation only if a consistent set of acceptable program versions can be detected, and the anesthesia device (G) is otherwise blocked.

主权项

1. A testing system for a medical device or for a system of medical devices, the medical device comprising a plurality of components, each of said components comprising a microprocessor and an executable program, wherein said executable program may be installed in different program versions on the respective component and wherein said executable program installed on the respective component can be replaced and/or changed independently from one another, the testing system comprising:
an access module or an acceptability memory provided for the medical device or for the system of medical devices, said access module or acceptability memory storing entries for all acceptable combinations of program versions for the executable programs of said components; a release and blocking device provided on the medical device or on each medical device of the system of medical devices, said release and blocking device controlling the initiation of operation of the medical device or each medical device of the system of medical devices or controlling the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices; a testing module provided for the medical device or for the system of medical devices detecting all program versions of all currently installed programs automatically as an actual state of the medical device or each medical device of the system of medical devices and checking said access module or acceptability memory as to whether the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry and to activate a release by said release and blocking device to allow initiation of operation of the medical device or each medical device of the system of medical devices or to allow the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry, wherein: the test module is provided with access to the access module or the acceptability memory; the testing module automatically detects all versions of all currently installed programs on all components of the medical device or system of medical devices as an actual state of the device; the testing module tests to determine whether the detected actual state of the device is acceptable by accessing the access module or an acceptability memory; and the testing module activates a release by said release and blocking device.