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Means of restricting access to changing or to the storage
of changes shall be described in the technical description (see 6.3.3.1, 6.5.3.1, 6.5.3.2, 6.5.4.1, 6.8.2 b) and c), 6.8.3 b), 6.8.5, and 6.10):
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EXAMPLE 1 Access
controlled by a tool.
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EXAMPLE 2 Access
controlled by RESPONSIBLE ORGANIZATION password and a
technical description that is separate from the instructions for use.
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EXAMPLE 3 Access
controlled by individual OPERATOR password. NOTE 1 For a password to be considered secure, the owner of the
password needs to be capable of changing the password.
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EXAMPLE 4 Access
controlled by voice recognition.
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EXAMPLE 5 Access
controlled by fingerprints.
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NOTE 2 Multiple
means of restriction can be needed, e.g., one for the RESPONSIBLE
ORGANIZATION and one for each OPERATOR.
Compliance
is checked by inspection of the technical documentation.
צריך להכלל גם ב-usability testing