Annex - DAkkS

Deutsche Akkreditierungsstelle GmbH
Annex to the Accreditation Certificate D-PL-19882-01-00
according to DIN EN ISO/IEC 17025:2005
Period of validity: 2014-08-01 to 2019-07-31 Date of issue: 2014-08-01
Holder of certificate:
Keysight Technologies Deutschland GmbH
Germany Hardware TestCenter ( GHTC)
Herrenberger Straße 130, 71034 Böblingen
Tests in the fields:
Electromagnetic Compatibility (EMC)
Electrical Safety
Environmental Testing
The testing laboratory is permitted, without being required to inform and obtain prior approval
from DAkkS, to use standard testing methods listed here with different issue dates.
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Electrical
Safety
DIN EN 61010-1:2011 Sicherheitsbestimmungen für elektrische Mess, Steuer-, Regel- und Laborgeräte – Teil 1:
VDE 0411-1:2011
Allgemeine Anforderungen (IEC 61010-1:2010 +
Cor.:2011); Deutsche Fassung EN 61010-1:2010
Safety requirements for electrical equipment
for measurement, control and laboratory use –
Part 1: General requirements (IEC 610101:2010 + Cor.:2011); German version EN 610101:2010
Electrical
Safety
IEC 61010-1:2010
Test area /
reductions
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 1: General requirements
This document is a translation. The definitive version is the original German annex to the accreditation certificate.
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Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Electrical
Safety
UL 61010-1:2012
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 1: General requirements (IEC 610101:2010, MOD) National Standard of USA
Electrical
Safety
CAN/CSA-C22.2 No.
61010-1-12
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 1: General requirements (IEC 610101:2010, MOD) National Standard of Canada
Electrical
Safety
DIN EN 61010-1:2002 Sicherheitsbestimmungen für elektrische Mess, Steuer-, Regel- und Laborgeräte – Allgemeine
VDE 0411-1:2002
Anforderungen (IEC 61010-1:2001); Deutsche
Fassung EN 61010-1:2001
Safety requirements for electrical equipment
for measurement, control and laboratory use –
Part 1: General requirements (IEC 610101:2001); German version EN 61010-1:2001
Electrical
Safety
IEC 61010-1:2001
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 1: General requirements
Electrical
Safety
UL 61010-1:2004
Safety Requirements for Electrical Equipment
for Measurement, Control, and Laboratory Use
– Part 1: General Requirements (IEC 610101:2001, MOD) National Standard of USA
Electrical
Safety
CAN/CSA-C22.2 No.
61010-1-04
Safety Requirements for Electrical Equipment
for Measurement, Control, and Laboratory Use
– Part 1: General Requirements (IEC 610101:2001, MOD) National Standard of Canada
Electrical
Safety
DIN EN 61010-2Sicherheitsbestimmungen für elektrische Mess010:2004
, Steuer-, Regel- und Laborgeräte – Teil 2-010:
VDE 0411-2-010:2004 Besondere Anforderungen an Laborgeräte für
das Erhitzen von Stoffen (IEC 61010-2010:2003); Deutsche Fassung EN 61010-2010:2003
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 2-010: Particular requirements for
laboratory equipment for the heating of
materials (IEC 61010-2-010:2003); German
version EN 61010-2-010:2003
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
2/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Electrical
Safety
IEC 61010-2-010:2003 Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 2-010: Particular requirements for
laboratory equipment for the heating of
materials
Electrical
Safety
DIN EN 61010-2Sicherheitsbestimmungen für elektrische Mess081:2004
, Steuer-, Regel- und Laborgeräte – Teil 2-081:
VDE 0411-2-081:2004 Besondere Anforderungen an automatische
und semiautomatische Laborgeräte für
Analysen und andere Zwecke (IEC 61010-2081:2001 + A1:2003); Deutsche Fassung EN
61010-2-081:2002 + A1:2003
Safety requirements for electrical equipment
for measurement, control and laboratory use –
Part 2-081: Particular requirements for
automatic and semi-automatic laboratory
equipment for analysis and other purposes (IEC
61010-2-081:2001 + A1:2003); German version
EN 61010-2-081:2002 + A1:2003
Electrical
Safety
IEC 61010-2-081:2001 Safety requirements for electrical equipment
+A1:2003
for measurement, control and laboratory use –
Part 2-081: Particular requirements for
automatic and semi-automatic laboratory
equipment for analysis and other purposes
Electrical
Safety
DIN EN 61010-2Sicherheitsbestimmungen für elektrische Mess101:2003
, Steuer-, Regel- und Laborgeräte – Teil 2-101:
VDE 0411-2-101:2003 Besondere Anforderungen an In-vitroDiagnostik-(IVD-)Medizingeräte (IEC 61010-2101:2002, modifiziert); Deutsche Fassung EN
61010-2-101:2002
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment (IEC 610102-101:2002, modified); German version EN
61010-2-101:2002
Electrical
Safety
IEC 61010-2-101:2002 Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical Equipment
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
3/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Electrical
Safety
DIN EN 60950-1:2011 Einrichtungen der Informationstechnik –
Sicherheit – T eil 1: Allgemeine Anforderungen
VDE 0805-1:2011
(IEC 60950-1:2005, modifiziert + Cor.:2006 +
A1:2009, modifiziert); Deutsche Fassung EN
60950-1:2006 + A11:2009 + A1:2010
Electrical
Safety
IEC 60950-1:2005
+A1:2009
Electrical
Safety
DIN EN 60825-1:2008 Sicherheit von Lasereinrichtungen – Teil 1:
Klassifizierung von Anlagen und Anforderungen
VDE 0837-1:2008
(IEC 60825-1:2007); Deutsche Fassung EN
60825-1:2007
Safety of laser products – Part 1: Equipment
classification and requirements (IEC 608251:2007); German version EN 61010-1:2007
Electrical
Safety
IEC 60825-1:2007
Test area /
reductions
Ausgenommen
Anhang U: Isolierte
Wickeldrähte zur
Verwendung ohne
isolierende
Zwischenlage
Information technology equipment – Safety – Excluding Annex U:
Part 1: General requirements (IEC 60950Insulating winding
1:2005, MOD + Cor.:2006 + A1:2009, MOD);
wires without
German version EN 60950-1:2006 + A11:2009 + interleaved
A1:2010
insulation.
Information technology equipment – Safety –
Part 1: General requirements
Excluding Annex U:
Insulating winding
wires without
interleaved
insulation.
Safety of laser products – Part 1: Equipment
classification and requirements
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
4/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
Environmental DIN EN 60068-2Testing
1:2008
VDE 0468-2-1:2008
Umgebungseinflüsse - Teil 2-1: Prüfverfahren Prüfung A: Kälte (IEC 60068-2-1:2007);
Deutsche Fassung EN 60068-2-1:2007
Environmental IEC 60068-2-1:2007
Testing
Environmental testing - Part 2-1: Tests - Tests A:
Cold
Environmental DIN EN 60068-2Testing
2:2008
VDE 0468-2-2:2008
Umgebungseinflüsse - Teil 2-2: Prüfverfahren Prüfung B: Trockene Wärme (IEC 60068-22:2007); Deutsche Fassung EN 60068-2-2:2007
Environmental IEC 60068-2-2:2007
Testing
Environmental testing - Part 2-2: Tests - Test B: 180°C <= T
Dry heat
Environmental DIN EN 60068-2Testing
6:2008
VDE 0468-2-6:2008
Umgebungseinflüsse - Teil 2-6: Prüfverfahren Prüfung Fc: Schwingen (sinusförmig)
(IEC 60068-2-6:2007); Deutsche Fassung
EN 60068-2-6:2008
5 Hz <= f <= 3000
Hz
Environmental IEC 60068-2-6:2007
Testing
Environmental testing - Part 2-6: Tests - Tests
Fc: Vibration (sinusoidal)
5 Hz <= f <= 3000
Hz
Environmental DIN EN 60068-2Testing
14:2010
VDE 0468-2-14:2010
Umgebungseinflüsse - Teil 2-14: Prüfverfahren Prüfung N: Temperaturwechsel (IEC 60068-214:2009); Deutsche Fassung EN 60068-214:2009
Environmental IEC 60068-2-14:2009
Testing
Environmental testing - Part 2-14: Tests - Test
N: Change of temperature
Environmental DIN EN 60068-2Testing
27:2010
VDE 0468-2-27:2010
Umgebungseinflüsse - Teil 2-27: Prüfverfahren Prüfung Ea und Leitfaden: Schocken (IEC 600682-27:2008); Deutsche Fassung EN 60068-227:2009
Environmental IEC 60068-2-27:2008
Testing
Environmental testing - Part 2-27: Tests - Test
Ea and guidance: Shock
Environmental DIN EN 60068-2Testing
30:2006
Umgebungseinflüsse - Teil 2-30: Prüfverfahren Prüfung Db: Feuchte Wärme, zyklisch
(12 + 12 Stunden) (IEC 60068-2-30:2005);
Deutsche Fassung EN 60068-2-30:2005
Environmental IEC 60068-2-30:2005
Testing
Environmental testing - Part 2-30: Tests - Test
Db: Damp heat, cyclic (12 h + 12 h cycle)
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
180°C <= T
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Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
Environmental DIN EN 60068-2Testing
31:2009
VDE 0468-2-31:2009
Umgebungseinflüsse - Teil 2-31: Prüfverfahren Prüfung Ec: Schocks durch raue Handhabung,
vornehmlich für Geräte (IEC 60068-2-31:2008);
Deutsche Fassung EN 60068-2-31:2008
Environmental IEC 60068-2-31:2008
Testing
Environmental testing - Part 2-31: Tests - Test
Ec: Rough handling shocks, primarily for
equipment-type specimens
Environmental DIN EN 60068-2Testing
38:2010
VDE 0468-2-38:2010
Umgebungseinflüsse - Teil 2-38: Prüfverfahren Prüfung Z/AD: Zusammengesetzte Prüfung,
Temperatur/Feuchte, zyklisch (IEC 60068-238:2009); Deutsche Fassung EN 60068-238:2009
Environmental IEC 60068-2-38:2009
Testing
Environmental testing - Part 2-38: Tests - Test
Z/AD: Composite temperature/humidity cyclic
test
Environmental DIN EN 60068-2Testing
64:2009
VDE 0468-2-64:2009
Umgebungseinflüsse - Teil 2-64: Prüfverfahren - 5 Hz <= f <= 3000
Hz
Prüfung Fh: Schwingen, Breitbandrauschen
(digital geregelt) und Leitfaden (IEC 60068-264:2008); Deutsche Fassung EN 60068-264:2008
Environmental IEC 60068-2-64:2008
Testing
Environmental testing - Part 2-64: Tests - Test 5 Hz <= f <= 3000
Fh: Vibration, broadband random and guidance Hz
Environmental DIN EN 60068-2Testing
78:2014
VDE 0468-2-78:2014
Umgebungseinflüsse - Teil 2-78: Prüfverfahren Prüfung Cab: Feuchte Wärme, konstant
(IEC 60068-2-78:2012); Deutsche Fassung
EN 60068-2-78:2013
Environmental IEC 60068-2-78:2012
Testing
Environmental testing - Part 2-78: Tests - Test
Cab: Damp heat, steady state
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
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Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 61000-42:2009
VDE 0847-4-2:2009
Elektromagnetische Verträglichkeit (EMV) - Teil
4-2: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen die Entladung statischer
Elektrizität (IEC 61000-4-2:2008); Deutsche
Fassung EN 61000-4-2:2009
Electromagnetic compatibility (EMC) - Part 4-2:
Testing and measurement techniques Electrostatic discharge immunity test (IEC
61000-4-2:2008); German version EN 61000-42:2009
EMC
DIN EN 61000-42:1996
VDE 0847-4-2:1996
Elektromagnetische Verträglichkeit (EMV) - Teil
4-2: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen die Entladung statischer
Elektrizität (IEC 61000-4-2:1995); Deutsche
Fassung EN 61000-4-2:1996
Electromagnetic compatibility (EMC) - Part 4-2:
Testing and measurement techniques Electrostatic discharge immunity test (IEC
61000-4-2:1995); German version EN 61000-42:1996
EMC
IEC 61000-4-2:2008
Electromagnetic compatibility (EMC) - Part 4-2:
Testing and measurement techniques Electrostatic discharge immunity test.
EMC
DIN EN 61000-43:2011
VDE 0847-4-3:2011
Elektromagnetische Verträglichkeit (EMV) - Teil
4-3: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen hochfrequente
elektromagnetische Felder (IEC 61000-4-3:2006
+ A1:2007 + A2:2010); Deutsche Fassung EN
61000-4-3:2006 + A1:2008 + A2:2010
Electromagnetic compatibility (EMC) - Part 4-3:
Testing and measurement techniques Radiated, radio-frequency, electromagnetic
field immunity test (IEC 61000-4-3:2006 +
A1:2007 + A2:2010); German version EN 610004-3:2006 + A1:2008 + A2:2010
EMC
lEC 61000-4-3:2006 + Electromagnetic compatibility (EMC) - Part 4-3:
A1:2007 + A2:2010
Testing and measurement techniques Radiated, radio-frequency, electromagnetic
field immunity test.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
f ≤ 2,7 GHz
illuminated area >
1 GHz: 1,5 x 1 m
(Points 1 -12, see
annex D.4)
f ≤ 2,7 GHz
illuminated area >
1 GHz: 1,5 x 1 m
(Points 1 -12, see
annex D.4)
7/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN 61000-44:2013
VDE 0847-4-4:2013
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
4-4: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen schnelle transiente
elektrische Störgrößen/Burst (IEC 61000-44:2012); Deutsche Fassung EN 61000-4-4:2012
Electromagnetic compatibility (EMC) - Part 44:Testing and measurement techniques Electrical fast transient/burst immunity test
(IEC 61000-4-4:2012); German version EN
61000-4-4:2012
EMC
lEC 61000-4-4:2012
Electromagnetic compatibility (EMG) - Part 4-4: Only single phase
equipment
Testing and measurement techniques Electrical fast transient/burst immunity test.
EMC
DIN EN 61000-44:2010
VDE 0847-4-4:2010
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
4-4: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen schnelle transiente
elektrische Störgrößen/Burst (IEC 61000-44:2004 + Cor. 1:2006 + Cor. 2:2007 + A1:2010);
Deutsche Fassung EN 61000-4-4:2004 +
A1:2010
Electromagnetic compatibility (EMC) - Part 4-4 :
Testing and measurement techniques Electrical fast transient/burst immunity test
(IEC 61000-4-4:2004 + Cor. 1:2006 + Cor.
2:2007 + A1:2010); German version EN 610004-4:2004 + A1:2010
EMC
lEC 61000-4-4:2004 + Electromagnetic compatibility (EMG) - Part 4-4: Only single phase
equipment
A1:2010
Testing and measurement techniques Electrical fast transient/burst immunity test.
EMC
DIN EN 61000-44:2005
VDE 0847-4-4:2005
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
4-4: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen schnelle transiente
elektrische Störgrößen/Burst (IEC 61000-44:2004); Deutsche Fassung EN 61000-4-4:2005
Electromagnetic compatibility (EMC) - Part 44:Testing and measurement techniques Electrical fast transient/burst immunity test
(IEC 61000-4-4:2004); German version EN
61000-4-4:2006
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
8/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN 61000-45:2007
VDE 0847-4-5:2007
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
4-5: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen Stoßspannungen (IEC
61000-4-5:2005); Deutsche Fassung EN 610004-5:2006
Electromagnetic Compatibility (EMC) - Part 4-5:
Testing and measurement techniques - Surge
immunity test (IEC 61000-4-5:2005); German
version EN 61000-4-5:2006
EMC
lEC 61000-4-5:2005
Electromagnetic compatibility (EMG) - Part 4-5: Only single phase
equipment
Testing and measurement techniques - Surge
immunity test.
EMC
DIN EN 61000-46:2009
VDE 0847-4-6:2009
Elektromagnetische Verträglichkeit (EMV) - Teil
4-6: Prüf- und Messverfahren - Störfestigkeit
gegen leitungsgeführte Störgrößen, induziert
durch hochfrequente Felder (IEC 61000-46:2008); Deutsche Fassung EN 61000-4-6:2009
Electromagnetic compatibility (EMC) - Part 4-6:
Testing and measurement techniques Immunity to conducted disturbances, induced
by radio-frequency fields (IEC 61000-4-6:2008);
German version EN 61000-4-6:2009
EMC
lEC 61000-4-6:2008
Electromagnetic compatibility (EMG) - Part 4-6:
Testing and measurement techniques Immunity to conducted disturbances, induced
by radio-frequency fields.
EMC
lEC 61000-4-6:2013
Electromagnetic compatibility (EMG) - Part 4-6:
Testing and measurement techniques Immunity to conducted disturbances, induced
by radio-frequency fields.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
9/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 61000-48:2010
VDE 0847-4-8:2010
Elektromagnetische Verträglichkeit (EMV) - Teil
4-8: Prüf- und Messverfahren - Prüfung der
Störfestigkeit gegen Magnetfelder mit
energietechnischen Frequenzen (IEC 61000-48:2009); Deutsche Fassung EN 61000-4-8:2010
Electromagnetic compatibility (EMC) - Part 4-8:
Testing and measurement techniques - Power
frequency magnetic field immunity test (IEC
61000-4-8:2009); German version EN 61000-48:2010
EMC
lEC 61000-4-8:2009
Electromagnetic compatibility (EMG) - Part 4-8:
Testing and measurement techniques - Power
frequency magnetic field immunity test.
EMC
DIN EN 61000-4-8:1994
Elektromagnetische Verträglichkeit (EMV) - Teil 4-8:
Prüf- und Messverfahren - Prüfung der Störfestigkeit
gegen Magnetfelder mit energietechnischen
Frequenzen (IEC 61000-4-8:1993); Deutsche Fassung
EN 61000-4-8:1993
VDE 0847-4-8:1994
Test area /
reductions
Electromagnetic compatibility (EMC) - Part 4-8:
Testing and measurement techniques - Power
frequency magnetic field immunity test (IEC 610004-8:1993); German version EN 61000-4-8:1993
EMC
DIN EN 61000-411:2005
VDE 0847-4-11:2005
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
4-11: Prüf- und Messverfahren - Prüfungen der equipment
Störfestigkeit gegen Spannungseinbrüche,
Kurzzeitunterbrechungen und
Spannungsschwankungen (IEC 61000-411:2004); Deutsche Fassung EN 61000-411:2004
Electromagnetic compatibility (EMC) - Part 411: Testing and measurement techniques Voltage dips, short interruptions and voltage
variations immunity tests (IEC 61000-411:2004); German version EN 61000-4-11:2004
EMC
lEC 61000-4-11:2004
Electromagnetic compatibility (EMG) - Part 411: Testing and measurement techniques Voltage dips, short interruptions and voltage
variations immunity tests.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Only single phase
equipment
10/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN 61000-32:2010
VDE 0838-2:2010
EMC
IEC 61000-3-2:2005 + Electromagnetic compatibility (EMG) - Part 3-2: Only single phase
A1:2008 + A2:2009
Limits – Limits for harmonic current emissions equipment
(equipment input current ≤ 16 A per phase).
EMC
EN 61000-3-3:2013
Electromagnetic compatibility (EMC) - Part 3-3: Only single phase
Limits - Limitation of voltage changes, voltage equipment
fluctuations and flicker in public low-voltage
supply systems, for equipment with rated
current <= 16 A per phase and not subject to
conditional connection (IEC 61000-3-3:2013)
EMC
IEC 61000-3-3:2013
Electromagnetic compatibility (EMC) - Part 3-3: Only single phase
Limits – Limitation of voltage changes, voltage equipment
fluctuations and flicker in public low-voltage
supply systems, for equipment with rated
current ≤ 16 A per phase and not subjected to
conditional connection.
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
3-2: Grenzwerte - Grenzwerte für
Oberschwingungsströme (GeräteEingangsstrom <= 16 A je Leiter) (IEC 61000-32:2005 + A1:2008 + A2:2009); Deutsche
Fassung EN 61000-3-2:2006 + A1:2009 +
A2:2009
Electromagnetic compatibility (EMC) - Part 3-2:
Limits - Limits for harmonic current emissions
(equipment input current <= 16 A per phase)
(IEC 61000-3-2:2005 + A1:2008 + A2:2009);
German version EN 61000-3-2:2006 + A1:2009
+ A2:2009
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
11/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN 61000-33:2009
VDE 0838-3:2009
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
3-3: Grenzwerte - Begrenzung von
Spannungsänderungen,
Spannungsschwankungen und Flicker in
öffentlichen NiederspannungsVersorgungsnetzen für Geräte mit einem
Bemessungsstrom <=16 A je Leiter, die keiner
Sonderanschlussbedingung unterliegen (IEC
61000-3-3:2008); Deutsche Fassung EN 610003-3:2008
Electromagnetic compatibility (EMC) - Part 3-3:
Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage
supply systems, for equipment with rated
current <=16 A per phase and not subject to
conditional connection (IEC 61000-3-3:2008);
German version EN 61000-3-3:2008
EMC
IEC 61000-3-3:2008
Electromagnetic compatibility (EMC) - Part 3-3: Only single phase
Limits – Limitation of voltage changes, voltage equipment
fluctuations and flicker in public low-voltage
supply systems, for equipment with rated
current ≤ 16 A per phase and not subjected to
conditional connection.
EMC
DIN EN 61000-33:1996
+ Berichtigung 1:1998
VDE 0838-3:1996
+ Berichtigung 1:1998
Elektromagnetische Verträglichkeit (EMV) - Teil Only single phase
equipment
3-3: Grenzwerte - Begrenzung von
Spannungsänderungen,
Spannungsschwankungen und Flicker in
öffentlichen NiederspannungsVersorgungsnetzen für Geräte mit einem
Bemessungsstrom <=16 A je Leiter, die keiner
Sonderanschlussbedingung unterliegen (IEC
61000-3-3:1994); Deutsche Fassung EN 610003-3:1995
Electromagnetic compatibility (EMC) - Part 3-3:
Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage
supply systems, for equipment with rated
current <=16 A per phase and not subject to
conditional connection (IEC 61000-3-3:1994);
German version EN 61000-3-3:1995
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
12/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 61000-61:2007
VDE 0839-6-1:2007
Elektromagnetische Verträglichkeit (EMV) - Teil
6-1: Fachgrundnormen - Störfestigkeit für
Wohnbereich, Geschäfts- und
Gewerbebereiche sowie Kleinbetriebe (IEC
61000-6-1:2005); Deutsche Fassung EN 610006-1:2007
Electromagnetic compatibility (EMC) - Part 6-1:
Generic standards - Immunity for residential,
commercial and light-industrial environments
(IEC 61000-6-1:2005); German version EN
61000-6-1:2007
EMC
IEC 61000-6-1:2005
Electromagnetic compatibility (EMC) - Part 6-1:
Generic standards - Immunity for residential,
commercial and light-industrial environments.
EMC
DIN EN 61000-62:2006
VDE 0839-6-2:2006
Elektromagnetische Verträglichkeit (EMV) - Teil
6-2: Fachgrundnormen - Störfestigkeit für
Industriebereiche (IEC 61000-6-2:2005);
Deutsche Fassung EN 61000-6-2:2005
Electromagnetic compatibility (EMC) - Part 6-2:
Generic standards - Immunity for industrial
environments (IEC 61000-6-2:2005); German
version EN 61000-6-2:2005
EMC
IEC 61000-6-2:2005
Electromagnetic compatibility (EMC) - Part 6-2:
Generic Standards - Immunity for industrial
environments.
EMC
DIN EN 61000-63:2011
VDE 0839-6-3:2011
Elektromagnetische Verträglichkeit (EMV) - Teil
6-3: Fachgrundnormen - Störaussendung für
Wohnbereich, Geschäfts- und
Gewerbebereiche sowie Kleinbetriebe (IEC
61000-6-3:2006 + A1:2010); Deutsche Fassung
EN 61000-6-3:2007 + A1:2011
Electromagnetic compatibility (EMC) - Part 6-3:
Generic standards - Emission standard for
residential, commercial and light-industrial
environments (IEC 61000-6-3:2006 + A1:2010);
German version EN 61000-6-3:2007 + A1:2011
EMC
IEC 61000-6-3:2006 + Electromagnetic compatibility (EMC) - Part 6-3:
A1:2010
Generic Standards - Emission for residential,
commercial and light-industrial environments.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
13/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN 61000-64:2011 + A1:2011
VDE 0839-6-4:2011
EMC
IEC 61000-6-4:2006 + Electromagnetic compatibility (EMC) - Part 6-4:
A1:2010
Generic Standards - Emission standard for
industrial environments.
EMC
DIN EN 55011:2011
VDE 0875-11:2011
Industrielle, wissenschaftliche und medizinische 150 kHz ≤ f ≤ 1 GHz
no frame antenna
Geräte - Funkstörungen - Grenzwerte und
Messverfahren (IEC/CISPR 11:2009, modifiziert
+ A1:2010); Deutsche Fassung EN 55011:2009 +
A1:2010
Industrial, scientific and medical equipment Radio-frequency disturbance characteristics Limits and methods of measurement (IEC/CISPR
11:2009, modified + A1:2010); German version
EN 55011:2009 + A1:2010
EMC
IEC/CISPR 11:2009 +
A1:2010
Industrial, scientific and medical (ISM) radiofrequency equipment - Electromagnetic
disturbance characteristics - Limits and
methods of measurement.
150 kHz ≤ f ≤ 1 GHz
no frame antenna
EMC
DIN EN 55022:2011
VDE 0878-22:2011
Einrichtungen der Informationstechnik Funkstöreigenschaften - Grenzwerte und
Messverfahren (CISPR 22:2008, modifiziert);
Deutsche Fassung EN 55022:2010
Information technology equipment - Radio
disturbance characteristics - Limits and
methods of measurement (CISPR 22:2008,
modified); German version EN 55022:2010
150 kHz ≤ f ≤ 1 GHz
EMC
IEC/CISPR 22:2008
Information technology equipment - Radio
disturbance characteristics - Limits and
methods of measurement.
150 kHz ≤ f ≤ 1 GHz
Elektromagnetische Verträglichkeit (EMV) - Teil
6-4: Fachgrundnormen - Störaussendung für
Industriebereiche (IEC 61000-6-4:2006 +
A1:2010); Deutsche Fassung EN 61000-64:2007 + A1:2011
Electromagnetic compatibility (EMC) - Part 6-4:
Generic standards - Emission standard for
industrial environments (IEC 61000-6-4:2006 +
A1:2010); German version EN 61000-6-4:2007 +
A1:2011
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
14/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 55024:2011
VDE 0878-24:2011
Einrichtungen der Informationstechnik Störfestigkeitseigenschaften - Grenzwerte und
Prüfverfahren (CISPR 24:2010); Deutsche
Fassung EN 55024:2010
Information technology equipment - Immunity
characteristics - Limits and methods of
measurement (CISPR 24:2010); German version
EN 55024:2010
EMC
IEC/CISPR 24:2010
Information technology equipment - Immunity
characteristics Limits and methods of
measurement.
EMC
DIN EN 61326-1:2013 Elektrische Mess-, Steuer-, Regel- und
VDE 0843-20-1:2013 Laborgeräte - EMV-Anforderungen - Teil 1:
Allgemeine Anforderungen (IEC 61326-1:2012);
Deutsche Fassung EN 61326-1:2013
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part 1:
General requirements (IEC 61326-1:2012);
German version EN 61326-1:2013
EMC
IEC 61326-1:2012
EMC
DIN EN 61326-2Elektrische Mess-, Steuer-, Regel- und
1:2013
Laborgeräte - EMV-Anforderungen - Teil 2-1:
VDE 0843-20-2-1:2013 Besondere Anforderungen - Prüfanordnung,
Betriebsbedingungen und Leistungsmerkmale
für empfindliche Prüf- und Messgeräte für
Anwendungen ohne EMV-Schutzmaßnahmen
(IEC 61326-2-1:2012); Deutsche Fassung EN
61326-2-1:2013
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-1: Particular requirements - Test
configurations, operational conditions and
performance criteria for sensitive test and
measurement equipment for EMC unprotected
applications (IEC 61326-2-1:2012); German
version EN 61326-2-1:2013
Test area /
reductions
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part 1:
General requirements.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
15/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
IEC 61326-2-1:2012
EMC
DIN EN 61326-2Elektrische Mess-, Steuer-, Regel- und
2:2013
Laborgeräte - EMV-Anforderungen - Teil 2-2:
VDE 0843-20-2-2:2013 Besondere Anforderungen - Prüfanordnung,
Betriebsbedingungen und Leistungsmerkmale
für ortsveränderliche Prüf-, Mess- und
Überwachungsgeräte für den Gebrauch in
Niederspannungs-Stromversorgungsnetzen (IEC
61326-2-2:2012); Deutsche Fassung EN 613262-2:2013
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-2: Particular requirements - Test
configurations, operational conditions and
performance criteria for portable test,
measuring and monitoring equipment used in
low-voltage distribution systems (IEC 61326-22:2012); German version EN 61326-2-2:2013
EMC
IEC 61326-2-2:2012
Test area /
reductions
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-1: Particular requirements - Test
configurations, operational conditions and
performance criteria for sensitive test and
measurement equipment for EMC unprotected
applications.
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-2: Particular requirements – Test
configurations, operational conditions and
performance criteria for portable test,
measuring and monitoring equipment used in
low-voltage distribution systems.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
16/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 61326-23:2013
VDE 0843-20-3:2013
Elektrische Mess-, Steuer-, Regel- und
Laborgeräte - EMV-Anforderungen - Teil 2-3:
Besondere Anforderungen - Prüfanordnung,
Betriebsbedingungen und Leistungsmerkmale
für Messgrößenumformer mit integrierter oder
abgesetzter Signalaufbereitung (IEC 61326-23:2012); Deutsche Fassung EN 61326-2-3:2013
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-3: Particular requirements - Test
configuration, operational conditions and
performance criteria for transducers with
integrated or remote signal conditioning (IEC
61326-2-3:2012); German version EN 61326-23:2013
EMC
IEC 61326-2-3:2012
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-3: Particular requirements – Test
configuration, operational conditions and
performance criteria for transducers with
integrated or remote signal conditioning.
EMC
DIN EN 61326-2Elektrische Mess-, Steuer-, Regel- und
6:2013
Laborgeräte - EMV-Anforderungen - Teil 2-6:
VDE 0843-20-2-6:2013 Besondere Anforderungen - Medizinische Invitro-Diagnosegeräte (IVD) (IEC 61326-26:2012); Deutsche Fassung EN 61326-2-6:2013
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-6: Particular requirements - In vitro
diagnostic (IVD) medical equipment (IEC 613262-6:2012); German version EN 61326-2-6:2013
EMC
IEC 61326-2-6:2012
Test area /
reductions
Electrical equipment for measurement, control
and laboratory use - EMC requirements - Part
2-6: Particular requirements In vitro diagnostic
(IVD) medical equipment.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
17/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 60601-12:2007
VDE 0750-1-2:2007
Medizinische elektrische Geräte - Teil 1-2:
Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen
Leistungsmerkmale - Ergänzungsnorm:
Elektromagnetische Verträglichkeit Anforderungen und Prüfungen (IEC 60601-12:2007, modifiziert); Deutsche Fassung EN
60601-1-2:2007
Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral standard:
Electromagnetic compatibility - Requirements
and tests (IEC 60601-1-2:2007, modified);
German version EN 60601-1-2:2007
EMC
IEC 60601-1-2:2007
Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance – Collateral standard:
Electromagnetic compatibility - Requirements
and tests.
EMC
DIN EN 60601-223:2000
VDE 0750-2-23:2000
Medizinische elektrische Geräte - Teil 2-23:
Besondere Festlegungen für die Sicherheit
einschließlich wesentlicher Leistungsmerkmale
von Geräten für die transkutane
Partialdrucküberwachung (IEC 60601-223:1999); Deutsche Fassung EN 60601-223:2000
Medical electrical equipment - Part 2-23:
Particular requirements for the safety,
including essential performance, of
transcutaneous partial pressure monitoring
equipment (IEC 60601-2-23:1999); German
version EN 60601-2-23:2000
EMC
IEC 60601-2-23:2011
Medical electrical equipment - Part 2-23:
Particular requirements for the safety,
including essential performance, of
transcutaneous partial pressure monitoring
equipment.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
18/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 60601-225:2001 + A1:2001
VDE 0750-2-25:2001
Medizinische elektrische Geräte - Teil 2-25:
Besondere Festlegungen für die Sicherheit von
Elektrokardiographen (IEC 60601-2-25:1993 +
A1:1999); Deutsche Fassung EN 60601-225:1995 + A1:1999
Medical electrical equipment - Part 2-25:
Particular requirements for the safety of
electrocardiographs (IEC 60601-2-25:1993 +
A1:1999); German version EN 60601-2-25:1995
+ A1:1999
EMC
IEC 60601-2-25:2011
Medical electrical equipment - Part 2-25:
Particular requirements for the safety of
electrocardiographs.
EMC
DIN EN 60601-226:2004
VDE 0750-2-26:2004
Medizinische elektrische Geräte - Teil 2-26:
Besondere Festlegungen für die Sicherheit von
Elektroenzephalographen (IEC 60601-226:2002); Deutsche Fassung EN 60601-226:2003
Medical electrical equipment - Part 2-26:
Particular requirements for the safety of
electroencephalographs (IEC 60601-2-26:2002);
German version EN 60601-2-26:2003
EMC
IEC 60601-2-26:2012
Medical electrical equipment - Part 2-26:
Particular requirements for the safety of
electroencephalographs.
EMC
DIN EN 60601-227:2006
VDE 0750-2-27:2006
Medizinische elektrische Geräte - Teil 2-27:
Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen
Leistungsmerkmale von ElektrokardiographieÜberwachungsgeräten (IEC 60601-2-27:2005);
Deutsche Fassung EN 60601-2-27:2006
Medical electrical equipment - Part 2-27:
Particular requirements for the safety,
including essential performance, of
electrocardiographic monitoring equipment
(IEC 60601-2-27:2005); German version EN
60601-2-27:2006
EMC
IEC 60601-2-27:2011
Medical electrical equipment - Part 2-27:
Particular requirements for the safety,
including essential performance, of
electrocardiographic monitoring equipment.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
19/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN 80601-230:2011
VDE 0750-2-30:2011
Replaces IEC
Medizinische elektrische Geräte - Teil 2-30:
60601-2-30
Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen
Leistungsmerkmale von automatisierten nichtinvasiven Blutdruckmessgeräten (IEC 80601-230:2009 + Cor. :2010); Deutsche Fassung EN
80601-2-30:2010
Medical electrical equipment - Part 2-30:
Particular requirements for the basic safety and
essential performance of automated type noninvasive sphygmomanometers (IEC 80601-230:2009 + Cor. :2010); German version EN
80601-2-30:2010
EMC
IEC 80601-2-30:2009
+ Corr. 1:2010
Replaces IEC
Medical electrical equipment - Part 2-30:
60601-2-30
Particular requirements for the safety,
including essential performance, of automatic
cycling non-invasive blood pressure monitoring
equipment.
EMC
DIN EN 60601-234:2001
VDE 0750-2-34:2001
Medizinische elektrische Geräte - Teil 2-34:
Besondere Festlegungen für die Sicherheit
einschließlich wesentlicher Leistungsmerkmale
von invasiven Blutdruck-Überwachungsgeräten
(IEC 60601-2-34:2000); Deutsche Fassung EN
60601-2-34:2000
Medical electrical equipment - Part 2-34:
Particular requirements for the safety,
including essential performance, of invasive
blood pressure monitoring equipment (IEC
60601-2-34:2000); German version EN 60601-234:2000
EMC
IEC 60601-2-34:2011
Medical electrical equipment - Part 2-34:
Particular requirements for the safety,
including essential performance, of invasive
blood pressure monitoring equipment.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
20/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
EMC
DIN EN 60601-237:2012
VDE 0750-2-37:2012
Medizinische elektrische Geräte - Teil 2-37:
Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen
Leistungsmerkmale von Ultraschallgeräten für
die medizinische Diagnose und Überwachung
(IEC 60601-2-37:2007); Deutsche Fassung EN
60601-2-37:2008 + A11:2011
Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and
essential performance of ultrasonic medical
diagnostic and monitoring equipment (IEC
60601-2-37:2007); German version EN 60601-237:2008 + A11:2011
EMC
IEC 60601-2-37:2007
Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and
essential performance of ultrasonic medical
diagnostic and monitoring equipment.
EMC
DIN EN 60601-249:2002
VDE 0750-2-49:2002
Medizinische elektrische Geräte - Teil 2-49:
Besondere Festlegungen für die Sicherheit von
multifunktionalen
Patientenüberwachungsgeräten (IEC 60601-249:2001); Deutsche Fassung EN 60601-249:2001
Medical electrical equipment - Part 2-49:
Particular requirements for the safety of
multifunction patient monitoring equipment
(IEC 60601-2-49:2001); German version EN
60601-2-49:2001
EMC
IEC 60601-2-49:2011
Medical electrical equipment - Part 2-49:
Particular requirements for the safety of
multifunction patient monitoring equipment.
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
Test area /
reductions
21/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
DIN EN ISO 80601-255:2012
VDE 0750-2-55:2012
Replaces ISO
Medizinische elektrische Geräte - Teil 2-55:
21647
Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen
Leistungsmerkmale von Überwachungsgeräten
für Atemgase (ISO 80601-2-55:2011); Deutsche
Fassung EN ISO 80601-2-55:2011
Medical electrical equipment - Part 2-55:
Particular requirements for the basic safety and
essential performance of respiratory gas
monitors (ISO 80601-2-55:2011); German
version EN ISO 80601-2-55:2011
EMC
ISO 80601-2-55:2011
Replaces ISO
Medical electrical equipment - Part 2-55:
Particular requirements for the basic safety and 21647
essential performance of respiratory gas
monitors
EMC
DIN EN ISO 80601-261:2012
VDE 0750-2-61:2012
Medizinische elektrische Geräte - Teil 2-61:
Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen
Leistungsmerkmale von Pulsoximetriegeräten
(ISO 80601-2-61:2011); Deutsche Fassung EN
ISO 80601-2-61:2011
Medical electrical equipment - Part 2-61:
Particular requirements for basic safety and
essential performance of pulse oximeter
equipment (ISO 80601-2-61:2011); German
version EN ISO 80601-2-61:2011
Replaces ISO 9919
EMC
ISO 80601-2-61:2011
Medical electrical equipment - Part 2-61:
Particular requirements for basic safety and
essential performance of pulse oximeter
equipment
Replaces ISO 9919
EMC
FCC Part 15 B
FCC Part 18
Code of federal regulations, Title 47:
Telecommunication Federal Communications
Commission (FCC):
- Part 15: Radio frequency devices - Subpart B:
Unintentional radiators
- Part 18: Industrial, scientific, and medical
equipment
Part 15 Subpart B
only: Radiated
Emissions
30 MHz < f < 1 GHz
Part 18: No induction
cooking or ultrasonic
equipment
No certification
EMC
ANSI C63.4:2009
American National Standard for Methods of
Measurement of Radio-Noise Emissions form
Low-Voltage Electrical and Electronic
Equipment in the Range of 9 kHz to 40 GHz.
f < 1 GHz
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
22/23
Annex to the accreditation certificate D-PL-19882-01-00
Department
Standard / in house
procedure / Version
Title of standard or in house procedure
(deviations / modifications of standard)
Test area /
reductions
EMC
MIL-STD-461F:2007
Sub-clause 5.16
Requirements for the control of
electromagnetic interference characteristics of RE101 only
subsystems and equipment
EMC
ETSI EN 3014891:2011
Electromagnetic compatibility and Radio
spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio
equipment and services; Part 1: Common
technical requirements
EMC
ETSI EN 30148917:2012
Electromagnetic compatibility and Radio
spectrum Matters (ERM); Electro Magnetic
Compatibility (EMC) standard for radio
equipment; Part 17: Specific conditions for
Broadband Data Transmission Systems
Period of validity: 2014-08-01 to 2019-07-31
Date of issue: 2014-08-01
- Translation -
23/23