al organizations concerned with metrology.
Besides ISO and IEC, which both are non–
govemmental organizations, two intergovern–
mental organizations were engaged namely
BIPM, Bureau International des Poids et Me–
sures, and OIML, Organisation International
de Metrologie Legale.
BIPM is subordinated to "Comite Interna–
tional des Poids et Mesures". This organiza–
tion has its roots in the "Convention du Me–
tre" which was signed in Paris in 1875. The
essential task of BIPM is to provide the ex–
perimental bases of the SI-system "Interna–
tional System of Units".
Like BIPM, OIML has about 50 member
countries from all over the world including the
Soviet Union, China, Japan. OIML was estab–
lished in 1955 because some people consid–
ered that BIPM did not fully meet the needs
for practical metrology. The name Organisa–
tion International de Metrologie Legal may
seem a little curious, but the term legal metrol–
ogy is deflned as all
applied metrology
subject–
ed to regulations by law or governmental de–
cree. Formally OIML is an important organi–
zation.
It
has many secretariats. The SP26, on
"Measuring Instruments Used in the Field of
Public Health" located in West Germany. Un–
der this seeretariat there is a reporting seere–
tariat SR5 on "Clinical Laboratory Reference
Materials" which is taken care of by NCCLS
in the US.
According to the secretariat's byelaws and
proeectures it "will develop written standards
to characterize clinical laboratory reference
materials for submission to OIML". Most
people engaged in clinical laboratory stand–
ardization seem to be unaware of this poten–
tially important activity. A first priority is ref–
erence material for blood cell counting, and a
document on this topic was prepared a year
ago.
ISO, BIPM and OIML together could be
considered as the highest gods of metrology.
We have also some minor chemistry gods like
IUPAC, the International Union of Pure and
Applied Chemistry, and IUB, the Internation-
22
al Union of Biochemistry. Their recommen–
dations on chemical terminology and enzyme
nomenciature should of course be followed.
WHO, ISQA AND COUNCIL OF
EUROPE
Let us now tum to our seeond faith, that of
medicine. For decades WHO has been very
active in Biological Standardization through
three laboratories with status as WHO Inter–
national Laboratories for Biological Stand–
ards, namely in England the National Institute
for Biological Standards and Control, in Den–
mark the State Serum Institute and in the
Netherlands the Central Laboratory of the
Netherlands Red Cross Blood Transfusion
Service. These laboratories prepare material
standards, but they also hold a stock of stand–
ards prepared in other laboratories. Every few
years WHO updates a publication called Bio–
logical Substances with the subtitle Interna–
tional Standards and Reference Reagents.
The most recent one, which appared in
1987, lists some 250 international standards
and reference reagents. The main fields are
antibiotics, antibodies, antigens, blood pro–
ducts and related substances, which includes
blood coagulation factors and other proteins,
and last but not least, endocrinological and
related substances.
(In 1987 the WHO Expert Committee on
Biological Standardization decided that in fu–
ture all preparations with international unit of
activity should be called International Stand–
ards, whereas other reference materials should
be designated as International Reference Re–
agents. The curious result is that a reference
material of insulin C-peptide is called a refer–
ence reagent because the amount of C-peptide
is given as lO
Jlg
per ampoule.)
The specifications for all these reference
materials are given in WHO's Technical Re–
port Series. In Number 760 of this series one
part is guidelines for the preparation, charac–
terization, and calibration of international
biological standards and reference reagents.
Klinisk kemi
i
Norden
