en Supplementary Information Approvals and Certificates
en Supplementary Information Approvals and Certificates
Document ID:
36200
1 Contents
Contents
1 About this document
2 CE conformity
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Development, function . . . . . . . . . . . . . . . . . . . . . . . 5
2.3 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5 Foodstuffs/Pharmaceutical
5.1 3-A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2 European Hygienic Equipment Design Group
(EHEDG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.3 Food and Drug Administration (FDA) . . . . . . . . . . . . . 20
6 Ship approval
6.1 ABS (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 22
6.2 BV (France) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 22
6.3 CCS (China) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
6.4 DNV (Norway) . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
6.5 GL (Germany) . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
6.6 KRS (Korea) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
6.7 LRS (Great Britain) . . . . . . . . . . . . . . . . . . . . . . . . .. 24
6.8 NKK (Japan) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 24
6.9 RINA (Italy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 24
6.10 RS (Russia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 24
8.2 Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
9 Fieldbus systems
9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
9.2 HART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
9.3 Profibus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
9.4 Foundation Fieldbus . . . . . . . . . . . . . . . . . . . . . . . . . 31
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2 CE conformity
2.1 Overview
The CE marking (either from the French Communauté Européenne =
"European Community" or Conformité Européenne as much as
"Conformity with EU directives") is a mark according to EU law for
certain products in relation to product safety. With the CE mark, the
manufacturer confirms that the product corresponds to the applicable
European directives. The CE mark allows no conclusions if the product
was tested by independent authorities on the compliance with these
directives. If there is a four digit figure after the CE mark, this means
that a notified body is involved in the conformity assessment
procedure. The CE mark is no seal of quality (quality mark).
Commitment The manufacturer confirms with the CE marking the conformity of the
product with the applicable EC directive and the compliance with the
stipulated "general requirements". The manufacturer of the product (for
manufacturers outside the EU, an authorized person located in the EU
is required) is normally responsible for the marking. As far as the
manufacturer has not attended his duty outside the EU, this duty is
passed on to his representative in the EU or the importer or at least the
distributor (colloquially the "Seller").
Features Products for which due to their kind or character, one of the EC
directives can be applied, must be provided with the CE marking
before they are put into circulation or set up. Manufacturers of a
technical product check on their own risk which EC directives they
have to apply during production. The product must only be put into
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2.3 Scope
The CE marking is a prerequisite for putting products into circulation
(or setting up) for the first time for which the CE marking is required
according to the following EC directives, i.e. in all member states of the
European Economic Area (EEA). The EEA comprises die EU member
states, except Switzerland. The CE marking is not required for putting
products into circulation in Switzerland. There are many special
conformity marking, the CE marking according to the EU directives,
however, is accepted.
http://ec.europa.eu
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3.1 Overview
Explosion protection When handling substances that can react which oxygen, an explosion
(Ex) danger must always be expected if there is a combustible substance
with a certain partial pressure in a room volume.
In explosion-endangered manufacturing facilities, i.e in areas where
the atmosphere is potentially explosive, all components of the
measuring system, for example for a level measurement, must have an
appropriate certificate.
Dust-explosion protec- If dusty substances with a sufficiently fine granulation are present in a
tion (StEx) sufficient quantity (for example min. layer thickness of 1 mm exceeded
in an area), then there is generally the danger of a dust explosion and
explosion protection measures must be taken.
The dust Ex zone comprises hazardous areas that are endangered
due to combustible dusts. If level measuring instruments are used in
these areas, they must have an appropriate certificate.
Certificate After a test authority has ensured the general safety requirements of
an instrument, they will prepare a test report. This test report is basis
for issuing an EC type examination certificate by the certification
authority (notified authority).
The Ex mark can be added to the product, when additionally a
certificate of an authority notified according to directive 97/9 on the
quality assurance of the production or the products for the
corresponding product group is available and when the manufacturer
has issued a conformity declaration on the conformity of the products
with the sample treated in the EC type approval certificate. Instruments
with CE mark enjoy free movement within the European Community.
explosion protection.
Basics of explosion pro- To create uniform guidelines for the definition of protective measures,
tection combustible liquids and gases have been classified into explosion
Explosion group The explosion groups with designation IIA, IIB, IIC concern the safe
gap and/or min. ignition current ratio, whereas group IIC includes the
most dangerous materials.
Temperature classes Combustible gases, vapours and fog are being divided into temper-
ature classes due to their inflammation temperature. The inflammation
temperature of a combustible medium is the lowest temperature of a
heated wall on which the combustible medium may ignite. The ignition
point is the lowest temperature where vapours from the liquid to be
tested envolve in such quantities that they form inflammable mixtures
together with air. The ignition point indicates up from which temper-
ature a mixture may occur being ignited by an ignition source, the
ignition temperature indicates the temperature of a surface or
apparatus which can really ignite a certain mixture.
Division of hazardous Hazardous areas are divided into zones according to the probable
areas into zones appearance of dangerous hazardous atmospheres to judge the
required protective measures.
Zone 0, 1 and 2 comprise areas with combustible gases, vapours and
fog.
Dust-explosion protec- The following criteria are particularly relevant for the hazardousness of
tion dusts:
Ignitable dust Dust particles with a granulation size of more than approx. 0.4 mm are
not ignitable. However fine dust produced during transport or
processing of the coarse dust due to abrasion can be ignitable. The
smaller the particles of a certain quantity, the larger the surface
becomes which can react with the oxygen. Dust layerings which are
whirled up, e.g. by air may be ignited by low surface temperatures.
Due to smaller, relatively harmless deflagrations it is possible that
larger dust quantities are whirled up which can ignite and due to a
chain reaction can whirl up more and more dust and lead to a larger
explosion.
Glow temperature
nature (explosivity) of dusts. The glow temperature of a dust deposit is
the lowest temperature of a hot surface on which a dust deposit of a
certain thickness will ignite.
Zone 20, 21 and 22 are valid for combustible dusts which are defined
as follows according to EN 61241-10:
Zone 22 Area in which under normal operation it is not expected that explosive
atmospheres in form of a cloud of combustible dust occur in air,
however if this occurs, then only shortterm. Note: Among these can
count areas around dust containing instruments, protective systems
and components in which dust can penetrate due to lack of tightness
and dust deposits can be caused (e.g. mills where dust can penetrate
and deposits are caused).
d = pressure-tight en-
closure
e = increased safety
o = oil encapsulation
p = overpressure enclo-
sure
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q = sand enclosure
m = casting
i = intrinsic safety
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Lc
Cc
Explosive area Limit values with Effective inner ca- Limit value of the
which the instru- pacitance or induc- power for the in-
ment can be oper- tance of the trinsically safe in-
ated instrument strument
Ui, Ii Ci, Li Pi
Lc Line inductance
Cc Line capacitance
Tab. 23: Proof of the intrinsic safety - Values for an associated instrument (example signal conditioning instrument)
Tab. 24: Proof of the intrinsic safety - Values for an intrinsically safe instrument (example radar sensor)
Tab. 25: Proof of the intrinsic safety - Values for a cable (example)
Li + Lc Ci + Cc
[mH] [nF]
Tab. 26: Proof of the intrinsic safety - Total values for an intrinsically safe instrument and a cable (example)
U Uo = 24.4 V ≤ Ui = 30 V
I Io = 110 mA ≤ Ii = 131 mA
P Po = 662 mW ≤ Pi = 983 mW
L Lo = 0.5 mH ≥ Li + Lc = 0.42 mH
C Co = 82 nF ≥ Ci + Cc = 27.54 nF
Tab. 27: Proof of the intrinsic safety for an intrinsically safe circuit (example)
Result:
All electrical parameters are in the permissible range. The conditions
for intrinsic safety are fulfilled.
Additional requirements After determining the intrinsic safety, it is the task of the person
responsible in the plant to install the system according to the
"Additional requirements" of EN 60079-14, particularly with respect to
the identification of the circuits, maintaining the specified distances
and separating the different circuits.
3.5 IECEx
The International Electrotechnical Commission, short: IEC is an
international standization committee for electrotechnical and elec-
tronics standards situated in Geneva. Some standards are developed
together with ISO.
The IEC consists of members, so called national committees (NC).
Each NC represents the national electrotechnical interests in the IEC.
Members are manufacturers, suppliers, distributors and providers,
consumers and users, all levels of governmental authorities, profes-
sional instituations and trade associations as well as developers of
national standards bodies.
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4.1 Overview
Instruments which are used in North America in hazardous areas must
be designed according to the North-American explosion protection
standards and certified by an authorized test authority.
The FM and CSA certificates are also accepted by other countries
outside North America.
Explosions protection standards are created by the organisations FM
(USA) and CSA (Canada). Authorized test authorities for testing and
certifying according to the standards are for example, FM, CSA, ITS. In
the USA and in Canada, the explosive atmospheres are divided into
zone 0 to 2 (can be compared with Europe) or in division 1 and 2. The
combustible substances are divided into class I, II, III and group A to G.
4.2 FM - USA
FM Global is an American commercial industrial insurance company
whose business is engineering-supported property insurance (FM
stands for Factory Mutual). Its offerings include general and
specialized risk management, materials research, materials testing
and certifications in the area of fire protection. Risk management is
understood to be the best possible avoidance of natural hazards
through appropriate preventative measures.
The oldest predecessor of FM Global came into being in 1835 when
the textile mill owner Zachariah Allen founded the Manufacturers
Mutual Fire Insurance Company in Rhode Iceland, USA. In the course
of the years, the group Associated Factory Mutual Fire Insurance
Companies (in short, Factory Mutual) arose through mergers with
other insurance companies. The acronym FM in its current name, FM
Global, comes from this shortened form of the name. FM Global in its
present form was created through the merger of the sister companies:
Allendale Mutual Insurance Company, Arkwright Mutual Insurance
Company and Protection Mutual Insurance Company in 1999.
FM approvals certify industrial products and consumer items as well
as their use for companies worldwide. If a product or its use fulfils the
requirements of the FM approval, then the "FM APPROVED" mark is
issued, in order to verify that the expected function works properly and
the product contributes to loss prevention.
www.fmglobal.com
5 Foodstuffs/Pharmaceutical
5.1 3-A
3-A stands for an organisation that was founded in 1920 in the USA to
create standards for the equipment and facilities used in dairy
factories. These standards are there to ensure product quality and
thus protect the health of the consumer.
The main work of 3-A is evaluating the constructive features of
instruments and systems. The organisation checks if the hygienic
design is maintained. An independent authority checks with the
manufacturers to make sure the specifications are applied in the
correct way (3rd Party Verification) and then issues a respective
certificate with test mark.
The certificate refers always to the combination instrument /process
fitting.
Parallel to the FDA, 3-A publishes a list of recommended materials for
the food processing industry. The principles of 3-A are also applied
outside the milk industry. 3-A also gives general recommendations for
the installation and operation of food processing systems.
3-A conform instruments have a 3-A logo outside on the housing.
www.3-a.com
The commission of the FDA is to protect public health in the USA. The
FDA checks the safety and efficacy of human and animal drugs,
biological products, medicinal products, foodstuffs and radiation
emitting devices. This applies to products manufactured in the USA as
well as imported products. Improving public health is also the FDA’s
job. It does this by supporting, among other things, the acceleration of
innovations which make medicine and foodstuffs more effective, safer
and more affordable.
To set down principles for the design of food processing machinery
and systems, the FDA has engaged the 3-A. The FDA itself
determines, for example, which materials may come into contact with
foodstuffs or pharmaceuticals. The laws and regulations of the USA
are laid down in the Code of Federal Regulations (CFR) and divided
up into about 50 subject areas.
The area of food and pharmaceuticals is discussed under CFR 21.
Synthetic materials that may come in contact with food are described
in part 177. The materials are treated as if they were additives to food.
Part 177 is therefore also called "Indirect food additives". Direct
additives are described in Part 172.
The FDA does not check materials on request but has prepared a
positive list in which materials, which in principle are considered safe,
are listed (GRASS = Generally Regarded As Safe). Every user must
take pains to ensure that the materials he uses are "Compliant with
FDA Guidelines".
Sealing materials, for example, must comply with FDA Compliance
chapter 21 CFR 177.2600, "Rubber articles for repeated use".
www.fda.gov
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6 Ship approval
There are instruments for use on ships that are type-examination
tested and certified by ship classification societies. In the context of the
International Association of Classification Societies, IACS, the follow-
ing member organizations are listed.
www.iacs.org.uk
l American Bureau of Shipping (ABS), USA
l Bureau Veritas (BV), France
l China Classification Society (CCS), China
l Det Norske Veritas (DNV), Norway
l Germanischer Lloyd (GL), Germany
l Korean Register of Shipping (KRS), Korea
l Lloyd’s Register of Shipping (LRS), England
l Nippon Kaiji Kyokai (NKK), Japan
l Registro Italiano Navale (RINA), Italy
l Maritime Register of Shipping (RS), Russia
The requirements for use on ships refer primarily to on-board supply
system, vibration and humidity effects.
6.2 BV (France)
Bureau Veritas S.A. is a technical testing organization that emerged
from a ship classification society founded in Antwerp in 1828. Today its
headquarters are in Paris. In the course of the years, its business
interest has extended itself to include, besides ships, many other
areas of industry with regard to inspection, assurance and certification
of quality, health and social environment. In 2006 Bureau Veritas was
represented in more than 150 countries and has about 700 agencies,
laboratories and offices at its disposal worldwide.
www.buerauveritas.com
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6.5 GL (Germany)
German Lloyd is a ship classification society. The society deals with
the care and support of the itinerant fleet classified at German Lloyd
and the supervision of new ship builds. Its supervisory activities also
cover technical maritime constructions and offshore equipment, partly
also plant construction. The necessary scientific methods are
developed further by German Lloyd both in the area of ship calculation
and machine technology.
www.gl-group.com
www.krs.co.kr
6.10 RS (Russia)
The classification society Russian Register was set up on December
31st, 1913, as the result of long-standing experience in the field of
technical supervision of ships. In 1923 Russian Register was renamed
7.1 Overview
Objective Functional safety acc. to IEC 61508 serves to protect persons,
technical systems and the environment with the means of MSR
technology.
Components that are used for safety instrumented system applications
must therefore possess a corresponding level of "functional safety"
(SIL = Safety Integrity Level).
SIL classification The level of "functional safety" of an SIS is divided up into gradations,
from SIL1 to SIL4 (SIL = Safety Integrity Level). The majority of SISs
have a classification of SIL1 and SIL2, in some cases also SIL3.
Derived from IEC 61508, the IEC 61511 determines for users in the
process industry how components with an appropriate SIL qualification
are integrated into a safety instrumented system.
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W3 W2 W1
C1 a - -
P1 SIL1 a -
F1
P2 SIL1 SIL1 a
C2
P1 SIL2 SIL1 SIL1
F2
P2 SIL3 SIL2 SIL1
C4 b SIL4 SIL3
C - Extent of damage
l C1 - Slight injury
l C2 - Serious irreversible injuries to one or more persons or death
of a person
l C3 - Death of several persons/long-term, sizable and harmful
environmental effects
l C4 - Disastrous consequences, many deaths
l
l F2 - Frequent to continuous
P - Danger avoidance
l P1 - Possible under certain conditions
l P2 - Hardly possible
SIL documentation The qualification of components as per IEC 61508 and/or IEC 61511 is
documented by a safety manual on the topic of functional safety. All
safety-relevant characteristics and information that users and planners
need for project planning and operation of the safety instrumented
system are summarized here. You can download this documentation
from our homepage www.vega.com.
Instruments with SIL If you order an instrument with SIL qualification (optional at extra
qualification charge), you get:
l An instrument with permanently activated SIL functionality (for
continuously measuring sensors)
l "SIL qualification" on the type plate
l The safety manual with all safety-relevant data
l The complete instrument documentation
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8.1 Overview
In Germany, an overfill protection acc. to WHG (Water Resources Act)
is required when handling water-endangering substances. In para-
graph 19 of WHG and in the associated state regulations concerning
systems for storing, filling and transhipping water-endangering
substances, the implementation of an overfill protection system is
mandated. All components of an overfill protection system for
containers storing water-endangering liquids must comply with the
approval principles for overfill protection. The sensors in such overfill
protection systems require approval.
8.2 Description
Basics, scope The Water Resources Act (WHG) of the Federal Government, as a
legal framework, is the basis for the water laws of the federal states
and is one of the most substantial laws dealing with environmental
protection. The WHG requires overfill protection systems to be
installed on all containers for water-endangering liquids. The purpose
of an overfill protection system as per the WHG is to monitor the level
of water-endangering liquids and to interrupt the filling process at the
right time before the permissible level in the container is reached or to
trigger an acoustical or visual alarm.
Approval as overfill pro- The products that have to be monitored are described in the catalogue
tection of water endangering substances (KWS) and divided up into water
endangerment classes 1 - 3. The Water Resources Act and the
associated state regulations concerning systems for the storage, filling
and transhipping of water-endangering substances (VAwS) make the
use of overfill protection systems mandatory. Such an overfill
protection system must have an approval. TÜV Hanover issues test
certificates concerning functional performance and compliance with
the approval principles for overfill protection (ZG-ÜS). On the basis of
this test, the German Institute for Civil Engineering (DIBt) grants a
general technical approval that is valid nationwide. The field of
application of overfill protection systems and the approval obligation of
such systems is legally anchored. The functionality of such systems is
thus guaranteed.
www.dibt.de
9 Fieldbus systems
9.1 Overview
Description A fieldbus is an industrial communication system that connects a
variety of field instruments such as sensing elements (sensors), final
controlling elements and drives (actuators) with a control device.
9.2 HART
Highway Addressable Remote Transducer (HART) is a standardized,
widely-used communication system for the construction of industrial
fieldbusses. It enables the digital communication of several partic-
ipants (field instruments) via a common data bus. HART particularly
makes use of the also widely-used 4 … 20 mA standard (for
transmission of analogue sensor signals). The existing cables of an
older system can be used directly and both systems operated parallel
to each other.
Development The company Rosemount developed HART in the 1980’s for its own
field instruments. The HART standard was created by the HART
Communication Foundation (HCF) in 1989. The domicile of the HART
Communication Foundation in Europe is in Basel (Switzerland).
Data transmission The data transmission is carried out via Frequency Shift Keying (FSK)
in compliance with the Bell 202 Standard. A high-frequency electric
oscillation (+/-0.5 mA) is superimposed on the low-frequency analogue
signal. A digital "1" is represented by the frequency 1.2 kHz (1200 Hz)
and digital "0" by the frequency 2.2 kHz (2200 Hz). HART specifies
several protocol levels in the OSI model and permits the transmission
of process and diagnostic information as well as control signals
between the field instruments and the primary control system.
Standardized parameter sets can be used for manufacturer inde-
pendent operation of all HART instruments. Most well-known
manufacturers of sensors (field instruments) offer instruments with – in
some cases optional – HART communication. Typical examples are
measuring transducers for the measurement of mechanical and
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electrical quantities.
www.hartcomm2.org
9.3 Profibus
The history of Profibus goes back to a publicly-sponsored, joint
research project in Germany in 1987, for which 21 companies and
institutes had drawn up a project outline plan called "Fieldbus". The
objective was the realization and distribution of a bit serial fieldbus,
whose foundation should be laid through the standardization of the
field device interface. To this end, relevant member companies agreed
to support a common technical concept for manufacturing and process
automation. As a first step, the complex communications protocol
Profibus FMS (Fieldbus Message Specification), especially designed
for demanding communication tasks, was specified. In later steps as of
1993, the specification of the more simply constructed and therefore
considerably faster protocol Profibus DP (Decentralized Peripherals)
was carried out.
Versions, data transmis- Profibus exists in three versions, of which DP is the most used:
sion Profibus DP (Decentralized Periphery) for control of sensors and
actuators through a central control in production engineering. The
many possible standard diagnostic functions are a major feature here.
Another important application is the linking of "distributed intelligence",
i.e. the networking of multiple controls among each other (similar to
Profibus FMS). Data rates up to 12 Mbit/sec. on twisted two-wire
cables and/or fibre-optic cables are possible.
In process and production engineering, Profibus PA (Process
Automation) is implemented for controlling measuring instruments via
a process control system. This version of Profibus is suitable for
explosion-prone areas (Ex zone 0 and 1). Here, only a weak current
flows through the bus cables of an intrinsically safe electrical circuit,
ensuring that no incendiary sparks can arise, even in case of failure.
www.profibus.com
Versions, data transmis- Foundation Fieldbus H1 uses the same bus physics as Profibus PA,
sion as per IEC 61158-2 with a transfer rate of 31.25 Kbit/s. Intrinsically
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Factory certification 2.1 - Factory certification 2.1 for instruments with the assurance of
Special features special features (Certificate A)
Certification verifying that the products listed in the factory certification
correspond with the stipulations of the order. Also with instrument-
specific assurance of special features without test protocols, such as
e.g. surface roughness as per AQL, oil and grease free, FDA
conformity, declaration of no objection for RADAR radiation, ROHS
statement, etc.
Acceptance test certifi- Acceptance test certificate 3.1 for instruments (Certificate B)
cate 3.1 Certification verifying that the product mentioned in the acceptance
test certificate corresponds to the technical delivery terms specified in
the order and was checked in all production phases and subjected to a
final inspection, in order to guarantee its proper functioning as well as
compliance with the high VEGA quality standard. Includes information
about the standard tests carried out and successfully passed
according to an instrument-specific test plan.
Acceptance test certifi- Acceptance test certificate 3.1 for instruments with assurance of
cate 3.1 - Special fea- special features (Certificate B)
tures Certification verifying that the product mentioned in the acceptance
test certificate corresponds to the technical delivery terms specified in
the order and was checked in all production phases and subjected to a
final inspection, in order to guarantee its proper functioning as well as
compliance with the high VEGA quality standard. Includes information
about the supplementary special test carried out and passed, which is
not included in the instrument-specific test plan and therefore has to be
additionally carried out. The test procedure and test protocol of the
special test are also documented in the approval certificate.
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Acceptance test certifi- Acceptance test certificate 3.1 for material (Certificate C)
cate 3.1 - Material Certificate verifying that the mechanical parts mentioned in the factory
certification correspond with the specifications in the order. Docu-
mented by material certificate 3.1 with information about the test
results from specific tests.
The acceptance test certificate 3.1 of the material manufacturer can be
directly related to the parts listed in the certification, because these are
clearly marked with the identification number (melt number). Docu-
mented by acceptance test certificate 3.1 of the material manufacturer
with information about the test results from specific tests.
Inspection certificate - Inspection certificate with measurement results from the refer-
Reference measuring ence measuring track
track Certification verifying that the product mentioned in the inspection
certificate corresponds to the technical features specified in the order
confirmation and was checked in all production phases and subjected
to a final inspection, in order to guarantee its proper functioning as well
as compliance with the high VEGA quality standard. Includes
measurement results from the reference measuring track (by default,
five measuring points linearly distributed along the adjustment or
measuring range of the sensor).
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VEGA Grieshaber KG
Am Hohenstein 113
77761 Schiltach
Germany
Phone +49 7836 50-0
Fax +49 7836 50-201
E-mail: [email protected]
www.vega.com
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