Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1183

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1183

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

AMY
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for AMY

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

5,722 µkat/L(343,3 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,161 µkat/L
2,8 %
2,0
> 50

(9,7 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
14.11.2013
14.11.2013
14.11.2013
15.11.2013
15.11.2013
15.11.2013
18.11.2013
18.11.2013
18.11.2013
19.11.2013
19.11.2013
19.11.2013

343,14 U/L
340,33 U/L
339,52 U/L
341,74 U/L
340,50 U/L
339,89 U/L
348,85 U/L
346,56 U/L
346,58 U/L
343,51 U/L
345,67 U/L
343,55 U/LStatistics of the single values
Number12
Mean
343,3 U/LSD
3,1 U/LCV
0,9 %Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1184

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1184

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

ALP
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for ALP

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

2,475 µkat/L(148,5 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,063 µkat/L
2,5 %
2,0
> 50

(3,8 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
02.12.2013
02.12.2013
02.12.2013
05.12.2013
05.12.2013
05.12.2013
09.12.2013
09.12.2013
09.12.2013
10.12.2013
10.12.2013
10.12.2013

147,03 U/L
146,15 U/L
148,21 U/L
148,49 U/L
148,31 U/L
150,09 U/L
150,75 U/L
150,78 U/L
150,49 U/L
146,78 U/L
147,52 U/L
147,21 U/LStatistics of the single values
Number12
Mean
148,5 U/LSD
1,7 U/LCV
1,1 %Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1185

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1185

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

ALT
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for ALT

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

2,716 µkat/L(163,0 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,060 µkat/L
2,2 %
2,0
> 50

(3,6 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
25.11.2013
25.11.2013
25.11.2013
26.11.2013
26.11.2013
26.11.2013
27.11.2013
27.11.2013
27.11.2013
28.11.2013
28.11.2013
28.11.2013

162,87 U/L
164,29 U/L
162,56 U/L
162,68 U/L
161,73 U/L
161,52 U/L
163,91 U/L
163,96 U/L
161,92 U/L
163,22 U/L
164,40 U/L
162,36 U/LStatistics of the single values
Number12
Mean
163,0 U/L
SD
1,0 U/LCV
0,6 %Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1186

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1186

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

AST
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for AST

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

2,780 µkat/L(166,8 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,062 µkat/L
2,2 %
2,0
> 50

(3,7 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
25.11.2013
25.11.2013
25.11.2013
26.11.2013
26.11.2013
26.11.2013
27.11.2013
27.11.2013
27.11.2013
28.11.2013
28.11.2013
28.11.2013

166,80 U/L
168,01 U/L
165,90 U/L
165,95 U/L
166,51 U/L
164,99 U/L
166,97 U/L
167,96 U/L
163,60 U/L
167,89 U/L
169,21 U/L
167,82 U/LStatistics of the single values
Number12
Mean
166,8 U/LSD
1,5 U/LCV
0,9 %Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1187

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1187

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

CK
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for CK

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

7,274 µkat/L(436,4 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,175 µkat/L
2,4 %
2,0
> 50

(10,5 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
11.12.2013
11.12.2013
11.12.2013
12.12.2013
12.12.2013
12.12.2013
16.12.2013
16.12.2013
16.12.2013
17.12.2013
17.12.2013
17.12.2013

435,12 U/L
433,21 U/L
435,08 U/L
434,25 U/L
439,24 U/L
442,37 U/L
431,81 U/L
436,91 U/L
438,39 U/L
435,26 U/L
439,97 U/L
435,62 U/LStatistics of the single values
Number12
Mean
436,4 U/LSD
3,0 U/LCV
0,7 %Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1188

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1188

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

GGT
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for GGT

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

2,501 µkat/L(150,1 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,062 µkat/L
2,5 %
2,0
> 50

(3,7 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
11.12.2013
11.12.2013
11.12.2013
12.12.2013
12.12.2013
12.12.2013
16.12.2013
16.12.2013
16.12.2013
17.12.2013
17.12.2013
17.12.2013

149,49 U/L
149,15 U/L
150,65 U/L
150,58 U/L
150,02 U/L
150,32 U/L
150,74 U/L
150,97 U/L
151,12 U/L
148,81 U/L
149,67 U/L
149,31 U/LStatistics of the single values
Number12
Mean
150,1 U/L
SD
0,8 U/LCV
0,5 %Kalibrierlaboratorium II
Calibration laboratory II

AKKREDITIERT DURCH DIE / ACCREDITED BY THE

Deutsche Akkreditierungsstelle GmbH
als Kalibrierlaboratorium im / as calibration laboratory in the

D-K-15117-02-00

Deutschen Kalibrierdienst

1189

Kalibrierschein
Calibration Certificate
GegenstandCalibrator

ObjectHersteller

D-K-1511702-00

Calibration mark2013-12

Dieser Kalibrierschein dokumentiert die
Rückführung auf nationale Normale zur
Darstellung der Einheiten in Übereinstimmungmit
demInternationalen
Einheitensystem (SI).

JCCLS

Manufacturer

Identifikation

CRM 001

Identification

Auftraggeber

Asahi Kasei
Tokyo, Japan

Customer

Auftragsnummer

ID-No. 896

Order No.

Anzahl der Seiten des Kalibrierscheins2

Number of pages of the certificate

Datum der Kalibrierung

Kalibrierzeichen

Dec 18, 2013

Date of calibration

Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European cooperation for Accreditation (EA) und derInternational
Laboratory
Accreditation
Cooperation (ILAC) zur gegenseitigen
Anerkennung der Kalibrierscheine.
Für die Einhaltung einer angemessenen
Frist zur Wiederholung der Kalibrierung ist
der Benutzer verantwortlich.
This calibration certificate documents thetraceability to national standards, which
realize the units of measurement according
to the International System of Units (SI).
The DAkkS is signatory to the multilateralagreements of the European co-operation
for Accreditation (EA) and of theInternational
Laboratory
Accreditation
Cooperation (ILAC) for the mutual
recognition of calibration certificates.
The user is obliged to have the object
recalibrated at appropriate intervals.

Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen derGenehmigung sowohl der Deutschen Akkreditierungsstelle GmbH als auch des ausstellenden Kalibrierlaboratoriums.
Kalibrierscheine ohne Unterschrift haben keine Gültigkeit.
This calibration certificate may not be reproduced other than in full except with the permission of both the Deutsche
Akkreditierungsstelle GmbH and the issuing laboratory. Calibration certificates without signature are not valid.

Datum
Date

Leiter des Kalibrierlaboratoriums
Head of the calibration laboratory

Bearbeiter
Person in charge

Prof. Dr. G. Schumann

R. Strache

Dec 19, 2013

Seite

2

1189

Page
D-K-1511702-00

The calibration is performed according to EN ISO 15195 and EN ISO 17025.
Object of calibration:

Calibrator
lyophilized

Analyte:System:Kind of quantity:

LDH
Buffer and stabilizer

2013-12

Catalytic activity concentration

Calibration procedure:

Determination of the catalytic concentration of enzymes
according to the primary IFCC reference procedure for LDH

Environmental condition:

The catalytic concentration refers to atemperature of 37 °C
One filling of the material of investigation was analyzed on eachmeasurement day. The number of measurement days and the numberof measurements per measurement day can be seen in the list with thesingle values.

Investigated random
sample:Measurement results:

Reference method value

7,130 µkat/L(427,8 U/L)

Expanded uncertainty of measurement
Relative expanded uncertainty of measurement
Coverage factor k
Effective degrees of freedom

0,161 µkat/L
2,3 %
2,0
> 50

(9,7 U/L)

The expanded uncertainty is declared and calculated by multiplying the standard uncertainty with the coveragefactor k = 2,0. The expanded uncertainty was calculated according to the document DAkkS-DKD-3. The valueof the measurable quantity lies within the attached range with a probability of 95 %.
The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of theInternational Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Further
signatories within and outside Europe can be seen on the websites of EA (www.european-accreditation.org) and ILAC
(www.ilac.org).

Single values
Date
Value
02.12.2013
02.12.2013
02.12.2013
05.12.2013
05.12.2013
05.12.2013
09.12.2013
09.12.2013
09.12.2013
10.12.2013
10.12.2013
10.12.2013

421,24 U/L
426,24 U/L
425,57 U/L
428,11 U/L
427,32 U/L
431,90 U/L
428,73 U/L
429,24 U/L
425,84 U/L
429,14 U/L
432,01 U/L
428,41 U/LStatistics of the single values
Number12
Mean
427,8 U/LSD
2,9 U/LCV
0,7 %Summary

Enzyme
AMY
ALP
ALT
AST
CK
GGT
LDH

Calibration
certificate
Name of theno.
Month Year Customer City
specimen1183
122013 Asahi Kasei Tokyo, Japan CRM 0011184
122013 Asahi Kasei Tokyo, Japan CRM 001
1185
122013 Asahi Kasei Tokyo, Japan CRM 0011186
122013 Asahi Kasei Tokyo, Japan CRM 0011187
122013 Asahi Kasei Tokyo, Japan CRM 0011188
122013 Asahi Kasei Tokyo, Japan CRM 0011189
122013 Asahi Kasei Tokyo, Japan CRM 001

Sh/Str/Kl 19.12.2013

Usage
MatrixCalibrator Buffer and stabilizer
Calibrator Buffer and stabilizer
Calibrator Buffer and stabilizer
Calibrator Buffer and stabilizer
Calibrator Buffer and stabilizer
Calibrator Buffer and stabilizer
Calibrator Buffer and stabilizer

Conditionlyophilizedlyophilizedlyophilizedlyophilizedlyophilizedlyophilizedlyophilized

Manufacturer Lot Code Beginning
JCCLS
1
896 28.10.2013
JCCLS
1
896 28.10.2013
JCCLS
1
896 28.10.2013
JCCLS
1
896 28.10.2013
JCCLS
1
896 28.10.2013
JCCLS
1
896 28.10.2013
JCCLS
1
896 28.10.2013

Summary

Enzyme
AMY
ALP
ALT
AST
CK
GGT
LDH

Calibration
certificate
u
u
no.
End
Days Values RMV SD CV (U/L) (%) k =U (U/L) U (%)
1183
18.12.2013
4
12343,3 3,1 0,9
1,6 0,5 2,00 (veff>50)
9,7
2,8
1184
18.12.2013
4
12
148,5 1,7 1,10,8 0,6 2,00 (veff>50)
3,8
2,5
1185
18.12.2013
4
12
163,0 0,6 0,40,3 0,2 2,00 (veff>50)
3,6
2,2
1186
18.12.2013
4
12
166,8 1,1 0,70,6 0,3 2,00 (veff>50)
3,7
2,2
1187
18.12.2013
4
12
436,4 1,8 0,40,9 0,2 2,00 (veff>50)
10,5
2,4
1188
18.12.2013
412
150,1 0,7 0,50,4 0,2 2,00 (veff>50)
3,7
2,5
1189
18.12.2013
4
12
427,8 2,4 0,6
1,2 0,3 2,00 (veff>50)
9,72,3

Sh/Str/Kl 19.12.2013