diff --git a/CHANGELOG.md b/CHANGELOG.md index 0d35c7a..77afa02 100644 --- a/CHANGELOG.md +++ b/CHANGELOG.md @@ -20,10 +20,17 @@ Each section shall contain a list of action items of the following format: `> may decide to limit user notification of technical issues to certain user groups (e.g., biomed). +====== Safety, Effectiveness & Security Considerations and Requirements + +.R1530 +[sdpi_requirement#r1530,sdpi_req_level=shall] +**** +If a <> is operational and loses connection to the <>, it shall use its internal clock. + +.Notes +[%collapsible] +==== +NOTE: It is likely that a <> needs multiple attempts to connect to a TS service a few times during the day. The system needs to be stable against these kind of short term interruptions. +==== +**** + +.R1531 +[sdpi_requirement#r1531,sdpi_req_level=shall] +**** +For every MDS of a <>, if the <> cannot reach the <> and is no longer able to provide a maximum error of 50ms relative to the <>'s clock, the <> shall provide pm:ClockState/@Accuracy. + +.Notes +[%collapsible] +==== +NOTE: This allows for the <> to decide if timestamps are accurate enough for its specific use case. +==== +**** +*REVIEWER QUESTION*:Is R1531 too challenging for legacy devices? + + +.R1532 +[sdpi_requirement#r1532,sdpi_req_level=shall] +**** +The <> of a <> shall consider the risk of providing the <>'s <> if the accuracy of the device internal clock decreases due to an unreachable <>. + +**** + +.R1533 +[sdpi_requirement#r1533,sdpi_req_level=shall] +**** +The <> of a <> shall consider the risk of providing the <>'s <> if the accuracy of the <>'s clock decreases. + +.Notes +[%collapsible] +==== +NOTE: In accordance with <>, a <> can assume that the accuracy of a <>'s clock is at least 50ms if no other value is provided in the <> pm:ClockState/@Accuracy. + +NOTE: This goes beyond considering the risk of erroneous timestamps required by the Base <> Standard, since it forces the <> of a <> to define a minimum accuracy acceptable for a <>. + +==== +**** + +*REVIEWER QUESTION*:Do we need a requirement, for notifying the biomed in case the <> is no longer reachable? Or is the following logging requirement sufficient? + +.R1534 +[sdpi_requirement#r1534,sdpi_req_level=shall] +**** +If a <> cannot reach the <>, the <> shall create a log entry. + +**** +*REVIEWER QUESTION*:Do we need a requirement stating this explicitly, or is BPKP TR0916 sufficient, since a <> not being available can be considered as a change in the <>. + ===== Scenario: <> {var_use_case_id}.5 - Devices are operational in the MD LAN network but cannot access the TS Service and clock drift is unacceptable -*Given* Device is operational on the <> network +*Given* The <> is operational on the <> network *And* The <> is no longer operational or otherwise inaccessible -*When* The clock drift of the device exceeds an internal threshold +*When* The clock drift of the device internal clock exceeds an internal threshold -*Then* The device will notify the user that time synchronization is no longer functional, which may limit the availability of SDC System Functionality +*Or* The timestamps of the received data are no longer accurate enough + +*Then* The device will notify the user that time synchronization is no longer functional, which will limit the availability of SDC System Functionality *And* The device will create a log entry noting inaccurate time synchronization *And* The device will periodically attempt to reconnect to the <> and <> -==== Safety, Effectiveness & Security Considerations and Requirements +*And* Based on a <>'s risk management, the device may be disconnected entirely from the <> network. + +NOTE: It is the <>'s responsibility to decide if timestamps are accurate enough to execute its <>. + +====== Safety, Effectiveness & Security Considerations and Requirements .R1500 [sdpi_requirement#r1500,sdpi_req_level=shall] @@ -136,4 +202,30 @@ NOTE: Clocks of <>s run apart due to l NOTE: This requirement supplements RR1162 in <>: _The MANUFACTURER of an SDC BASE CONSUMER SHALL consider the RISKs resulting from erroneous timestamps._ ==== -**** \ No newline at end of file +**** + +.R1540 +[sdpi_requirement#r1540,sdpi_req_level=shall] +**** +If a <> receives an <> containing a pm:ClockState/@Accuracy that is no longer sufficient for at least one of its <>s, the <> shall disable all affected <>s. +**** + +.R1541 +[sdpi_requirement#r1541,sdpi_req_level=shall] +**** +If a <>'s internal clock is no longer sufficient for at least one of its <>s, the <> shall disable all affected <>s. +**** + +.R1542 +[sdpi_requirement#r1542,sdpi_req_level=shall] +**** +When a <> disables one or more <>s, the <> shall notify the user. +**** + +.R1543 +[sdpi_requirement#r1543,sdpi_req_level=shall] +**** +If a <> disables one or more <>s, the <> shall create a log entry, noting the disabled <>s as well as the cause for disabling them. +**** + +