GB/T 21415-2008 English PDF (GBT21415-2008)

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GB/T 21415-2008: In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
GB/T 21415–2008
GB
ICS 11.100
C 44
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
GB/T 21415-2008 / ISO 17511.2003
In vitro diagnostic medical devices -
Measurement of quantities in biological samples -
Metrological traceability of values assigned to
calibrators and control materials
体外诊断医疗器械
(ISO 17511. 2003, IDT)
ISSUED ON. JANUARY 22, 2008
IMPLEMENTED ON. SEPTEMBER 01, 2008
Issued by. General Administration of Quality Supervision, Inspection
and Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword ... 3 
Introduction ... 4 
1  Scope ... 7 
2  Normative references ... 8 
3  Terms and definitions ... 8 
4  Metrological traceability chain and calibration hierarchy ... 17 
4.1  Principles ... 17 
4.2  Structure and nomenclature ... 19 
4.3  Considerations in establishing metrological traceability ... 23 
4.4  Functions of reference materials ... 25 
5  Calibration transfer protocols ... 26 
5.1  Availability and structure ... 26 
5.2  Cases with primary reference measurement procedure and
primary calibrators) giving metrological traceability to SI ... 26 
5.3  Cases with international conventional reference measurement
procedure (which is not primary) and international conventional
calibrators) without metrological traceability to SI ... 28 
5.4  Cases with international conventional reference measurement
procedure (which is not primary) but no international conventional
calibrator and without metrological traceability to SI ... 29 
5.5  Cases with international conventional calibrator (which is not
primary) but no international conventional reference measurement
procedure and without metrological traceability to SI ... 30 
5.6  Cases with manufacturer's selected measurement procedure
but neither international conventional reference measurement
procedure nor international conventional calibrator and without
metrological traceability to SI ... 31 
5.7  Trueness control materials ... 32 
6  Expression of uncertainty of measurement ... 32 
7  Validation of metrologically traceable calibration ... 33 
8  Information on metrological traceability to be given in the instructions for
use of an in vitro diagnostic medical device ... 35 
Bibliography ... 36 
Foreword 
This Standard equivalently adopts ISO 17511. 2003 In vitro diagnostic medical devices —
Measurement of quantities in biological samples — Metrological traceability of values
assigned to calibrators and control materials.
For ease of use, the editorial modifications have been made in this Standard as follows.
— Modify the “international standard” to “this Standard”;
— Replace the comma “,” with decimal point “.”;
— Delete the foreword of international standard.
The Standard was proposed by China Food and Drug Administration.
The Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
The responsible drafting organizations of this Standard. Beijing Institute of Medical Device
Testing, and Roche Diagnostics (Shanghai) Co., Ltd.
The chief drafting staffs of this Standard. Zong Yulong, Feng Renfeng, Zhang Xinmei, Hu
Dongmei, Tao Yuan, and Kang Juan.
32) Stockl D, Franzini C, Kratochvila J, Middle J, Ricos C, Siekmann L, Thienpont LM.
Analytical specifications of reference methods. Compilation and critical discussion
(From the members of the European EQA-organizers Working Group B) [Review].
Eur J Clin Chem Clin Biochem 1996;34.319-37.
33) Velapoldi RA, Paule RC, Schaffer R, Mandel J, Machlan LA, Gramlich JW. A
reference method for the determination of potassium in serum (Special Publication
260-60). Gaithersburg. National Bureau of Standards;1979.
34) WHO. Guidelines for the preparation, characterization and establishment of
international and other standards and reference reagents for biological substances.
Techn Rep Ser 1990;No.800 (Annex 4).181-214.