Frequently Asked Questions about
European Reference Materials ERM®
Why? - What is the “big idea” behind European Reference Materials?
Currently there are many European reference materials producers that are individually centres of
competence. Most of these offer quite restricted ranges of products and are not widely recognised
internationally. By uniting under the European Reference Materials ERM® brand they are able to pool
their knowledge and resources and present a strong European brand to an international audience.
Through adoption of the latest principles of production and certification and thorough peer review it is
possible to offer an increased range of internationally-recognised, high quality certified reference
materials (CRMs).
What is an ERM®
branded material?
What is the difference between CRM, RM,
SRM, ERM?
An ERM is a CRM with the added value that
very stringent quality criteria regarding
production, homogeneity and stability testing,
and of course characterisation
measurements, have to be fulfilled. A special
panel made up of leading experts in the field
scrutinises every application before the ERM®
label is granted.
What is a CRM?
for
erial which is used either
ce material (CRM) is a mat
The
.
tion
bra
cali
for
Briefly, a certified referen
or
,
lar to check for method bias
method validation, in particu
de is:- a CRM is a
the corresponding ISO Gui
in
ned
defi
as
wer
formal ans
procedure for one or
d
vali
lly
gica
terised by a metrolo
provides the value of
reference material charac
that
te
accompanied by a certifica
ies,
l
pert
pro
d
cifie
spe
e
em
mor
a stat ent of metrologica
associated uncertainty and
the specified property, its
traceability.
an European
nefits of buying
be
n
ai
m
e
th
e
ar
What
ials?
d their
Reference Mater
certified values an
nfidence in the
rigorous
Users can have co ult of the demanding criteria and
res
a
cers are
du
pro
e
Th
.
en
uncertainties as
giv
certified value is
tion process is
scrutiny that each
and
re that the certifica
su
g
kin
ma
to
d
the clearly defined
th
wi
committe
er
eth
tog
ct
pe
the
as
th
is
wi
Th
.
ers
all
us
e
transparent for
lues will provid
particular
of the certified va
the suitability of a
stated traceability
ate
alu
ev
ly
ful
to
ed
ne
y
the
on
ati
inform
cation.
CRM for their appli
How doe
s
a produc
In order to
t become
be include
an ERM ®
(CRM) mu
d in the E
?
R ®
st satisfy
a number M range a certifie
productio
of deman
d reference
n of the m
din
ate
homogen
m
eity and st rial, the way in wh g criteria with respe aterial
ich
abili
ct to the
and 35. A
panel of le ty. These criteria a it was characterise
d,
scrutinise
re specifie
ading exp
sa
erts in the
d in ISO G its
field of re
become E ll applications to e
ference m uides 34
nsure only
RMs
aterials
the highe
st quality
products
e mean?
What does the shelf-lif
a specified
terials guarantee within
ma
Producers of reference
the validity of the
grity of the material and
sample is properly
time (=shelf life) the inte
the
d
the material, provide
guarantee this
certificate accompanying
ers
duc
. Furthermore, most pro
ds, once the
wor
transported and stored
er
oth
In
er.
tain
con
unopened
no longer
can
y
only for materials in an
grit
inte
al
teri
er is opened ma
user has to
the
t
original material contain
tha
an
s not automatically me
al will remain
be guaranteed. This doe
teri
ma
the
lly,
ma
Nor
.
sample
throw away the unused
er suitable conditions.
stable when stored und
For what applications are ERM® CRMs suitable?
The ERM® range of reference materials covers the following
applications: environmental, food/agriculture, industrial and clinical.
There are also calibration standards certified for purity, concentration,
and activity, or for physical properties including melting point, hardness
and optical properties.
Reference material (RM) is the generic term for a group of
either pure substances or matrix materials, which are used for
calibration, method validation, the establishment of
traceability, method development, and various quality control
purposes (proficiency testing, charting, etc). If the reference
material fulfils a number of requirements (proven homogeneity
and stability, characterisation of the property values using
suitable, well described and validated methods) this information may be summed up in a certificate, thus being a certified
reference materials.
SRM is a trademark registered by the US National Institute for
Standards and Technology (NIST) for the certified reference
materials they produce and stands for Standard Reference
Material. An ERM belongs to the group of CRMs which carry
the trademark ERM®.
fied
ility mean for Certi
What does traceab
?
s)
RM
(C
ls
Reference Materia logy defines traceability
cabulary of Metro
The International Vo
whereby the result
measurement result
a
of
rty
pe
as the pro
unbroken chain of
an
gh
erence throu
rement
can be related to a ref
tributing to the measu
calibrations, each con
to anchor the
ans
me
this
ms
ter
al
practic
uncertainty. In more
over time and place
which do not change
results to standards
comparable.
ults
asurement res
in order to make me
a CRM shall be
of
s)
ue(
val
d
tifie
Consequently, the cer
standards,
rnationally accepted
traceable to such inte
ient way to
ven
con
a
is
M
Use of a CR
preferably to the SI.
ty.
demonstrate traceabili
eable to e.g. the SI,
lue of the CRM is trac
va
rty
pe
pro
If the
e traceability to SI
vid
pro
ent results
then these measurem
ertainty of the
is only valid if the unc
units. However, this
ing into account
tak
ly
per
pro
are
M
CR
ly matched by
property values of the
ent
fici
suf
are
sample
and if the nature of the el/matrix of the CRM.
the analyte lev
do I
How
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nts?
lue
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certificate.
© European Communities, 2008. Reproduction is authorised, provided the source is acknowledged © European Communities, 2008. Reproduction is authorised, provided the source is acknowledged. Neither the European Commission nor any person acting on behalf of the Commission is responsible
for the use which might be made of the following information
How should I use the data obtained on measurements of a Certified Reference Material
(CRM)?
There are several possible uses for the data obtained from a measurement of a CRM. It can be used to:- Validate a method of measurement. This is to see if the observed value and the certified value agree within the
uncertainty.
- Verify a specific measurement procedure. This is to see, if the observed value and the certified value agree within
the uncertainty under the specific laboratory conditions.
- Control the accuracy of measurements within the uncertainty.
- Calibrate a measurement device for a specific type of measurement. This is to establish the relation between a
‘signal’ and the quantity intended to be measured (usually a concentration). In the simplest case, a calibration factor
and its uncertainty is calculated from the observed value and the certified value.
- Underpinning proficiency testing. The use of a well characterised test sample, unknown by the PT participants,
enables their performance to be monitored against certified values instead of the consensus values. Moreover, the
homogeneity and stability of such a PT test sample will have been characterised already.
- Develop new methods of measurement.
- Estimate measurement uncertainty.
®
ly for Europeans?
Materials, ERM on
®
r the ERM brand
ials marketed unde
ter
Ma
.
ce
by all
ran
iew
su
as
rev
ct to extensive
highest level of
will have been subje
nce materials of the
t
d
ere
Bu
an
.
ref
35
ility
es
d
ab
uir
an
cap
req
34
No
l
o
s
na
wh
o have internatio
down in ISO Guide
y
itable for any user
the principles laid
monstrate that the
terial distributors wh
ERM-CRMs are su
Union who can de
in accordance with
er of reference ma
n
d
mb
ea
ce
nu
rop
du
a
Eu
pro
m
fro
en
the
in
be
ble
®
will have
are availa
producers located
ns. ERM materials
reference materials
®
member organisatio
hip is open only to
ers
rtn
pa
M
ER
membership of the
eria.
at
ed membership crit
004
meet certain defin
tart?ce in May 2talogue
s
t
i
l ca
pla
s
did
hen® range tooky. A speciaaterials wa
Who owns the Eu
W
n
ro
m
pe
a
an Reference Mate
ce
RM , Germ
ERM® materials?
rials
feren
h
the E
h of in Munic ertified re asion.
c
n
u
Each ERM material
c
la
c
is owned by one of
The tica 2004 first 146 for the oc
the members of the
cooperation. The ow
naly ing the oduced
ERM®
ner is fully respons
A
r
in
ible for its material
p
i.e. production, rep
s
lacement, stability,
conta
storage, product lia
bility, etc.
ference
Are European Re
®
ation?
members of the ERM cooper , namely the Institute for
tutes
Who is involved? Who are the
insti
t
men
sure
mea
ted
repu
three well-
are
The founding partners of the ERM
European Commission’s Joint
ments (IRMM), an institute of the
Reference Materials and Measure
surement institute for chemical
mea
nal
ed Kingdom’s designated natio
Unit
the
LGC
tre,
Cen
h
earc
Res
Research and Testing
the Federal Institute for Materials
and biochemical analysis, and
authority of the
the
r
unde
ute
Is the ERM® conc
senior federal instit
(BAM), a technical and scientific
ep
any.
Germ
in
ur
Labo
and
CRM producers? t only for EU
Federal Ministry of Economics
The Trademark
owner (European
Community) is
not prepared to
give a licence for
the trademark
to
an
ins
in
titu
lts
te
ou
tside the EU.
nt resu
easureme
of Weights
M-MRA? mutual recognition of m
IP
ee
C
itt
m
e
th
om
C
What is RA is a document of by the ‘International llowing the Metre
-M
was set up in measurements fo
What are signatories/designated laboratories of the
The CIPM
ity
untries, and
different co s’, the highest author
ml is:CIPM-MRA?
ht
s.
e
re
iv
ct
su
e
and Mea
n/mra/obj
standards
t
tio
CIPM-MRA
are the legal representatives of the
en
en
Signatories
of
the
m
nv
e
o
ur
/c
n.
n
nal meas
Conventio RA www.bipm.org/e
highest authority for measurements in their country.
nce of natio
le
a
-M
iv
s
M
qu
te
IP
e
C
f
ca
The
ree o
ent certifi
Typically these representatives are the directors the National
ing the deg s
measurem
- establish
ration and
atorie
lib
gn
Measurement
Institutes (NMIs). For specific fields of measurements,
si
ca
f
o
by
nical
maintained e mutual recognition
the representatives can designate other laboratories as authority in
th
secure tech ce
a
ng
ith
di
w
vi
s
ro
-p
partie
their country.
de, commer
signatories. rnments and other
ational tra
issued by
d to intern
Signatories/designated laboratories are listed:
ing gove
te
id
la
ov
re
pr
ts
y
reemen
- thereb
www.bipm.org/utils/en/pdf/signatories.pdf
for wider ag
foundation
.
irs
fa
af
ry
to
la
gu
re
and
Is the ERM® cooperation a closed club?
ERM® is not a closed club, but explicitly open to new members, who fulfil the defined membership criteria as given under www.erm-crm.org.
The summarised criteria are:
- Be located within the European Union and be a signatory or designated laboratory of the CIPM-MRA.
- Be a producer of certified reference materials who fulfils agreed quality standards, in particular by having in place a quality system for the production
of CRMs in accordance with ISO Guide 34 and 35.
- Accept all principles of the ERM® Memorandum of Understanding.
The role of the three ‘founding’ partners is as the nucleus of the ERM®.
mark?
Who owns the trade
®
tradema®rk.
unity owns the ERM
ERM partner
The European Comm
the
to
ark
dem
tra
®
nces the
M in accordance
The Community lice
ER
as
ted
ep
rk products acc
organisations ®to ma
with the ERM rules.
When
does the tradem
The ERM ® trade
ark expire?
mark is licensed
to member organ
ERM ® co-operatio
isations for the du
n provided the lic
ratio
ensee continues
co-operation an
d to follow its rul
to remain a memb n of the
es.
er of the
Licensees are ob
liged not to use
the Trademark for
accepted as ER ®
any materials, wh
M .
ich are not
How to find out more about European Reference Materials
Please visit www.erm-crm.org
Status April 2008