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Group 5: Validation based on TUV-SUD, BP (Ketua: Zul) (AUDITING AND SYSTEM…
Group 5: Validation based on TUV-SUD, BP (Ketua: Zul)
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Validation
To validate is to prove that something is based on truth or fact, or is acceptable. It can also mean to make something, like a contract, legal.
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BP Validation Process
BP Validation Procedure
subject seated comfortably and relaxed for at least 5 minutes, her/his back and arm supported with the middle of the upper arm at heart level, legs uncrossed, and feet flat on the floor.
The reference BP measurement (R0) taken by the 2 observers, followed by a test device measurement (T0) to confirm the device function
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The supervisor will review each pair of test/reference BP measurements. A maximum of 8 pairs is allowed.
Observers’ BP comparison during the validation study shall be reported (mean difference, standard deviation, and range) together with the number of repeated measurements
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