Siemens Healthcare Diagnostics Products GmbH

P. O. Box 1149
35001 Marburg, Germany
diagnostics.siemens.com

Certificate of Traceability
Assigned Values

This is to certify the traceability of the assigned values of the product listed below to a reference material.

The uncertainty of the assigned value for this product was calculated according to the ISO norm 17511 by using
a coverage factor of two. Expressing the uncertainty by a coefficient of variation can be done by dividing the
given uncertainty by two.

Product PT-Multi Calibrator

Product Code OPAT

Parameter PT with Thromborel S

Unit INR

Device for usage of assigned value Sysmex® CA-500 and CA-600 Series

WHO rTF / 09
Reference material
Fresh normal plasma samples

Measuring method used for value assignment Nephelometry

Uncertainty of assigned values [%] L1: 2.8, L2: 3.0, L3: 3.4, L4: 5.4, L5: 6.9

This document was produced by means of an electronic system, therefore without signature

Name of document: D-00015 Effective date: 2013-07-12 Page 1 of 2

Siemens Healthcare Diagnostics Products GmbH
P. O. Box 1149
35001 Marburg, Germany
diagnostics.siemens.com

Traceability Chart
This is to certify the traceability chain of the assigned values of the product listed below to a reference material.

Product PT-Multi Calibrator

Product Code OPAT

Parameter PT with Thromborel S

Unit INR

Materials & Procedures Section1)

WHO rTF / 09 ab
Fresh normal plasma samples
→

Primary calibration ab

←
ISI and MNPT determination for
ab
Master lot Thromborel S
→
Secondary calibration of PT Multi
b
Calibrator
←
Calibration of new PTMC on multiple
b
occasions and per instrument type
→
Calculation of PTMC-level INRs using
determined PTMC values, MNPT and b

←
Thromborel S Master Lot ISI
Assignment of calculated PTMC-INR
b
values to individual levels
→

Use of calibrated values by customer c

-
1)
a = External material / procedure
b = Company internal
c = Use of assigned value by customer

Name of document: D-00015 Effective date: 2013-07-12 Page 2 of 2