Proline Promass E 300 Modbus RS485
Technical data
Hauser
195
Pharmaceutical
compatibility
• FDA 21 CFR 177
• USP <87>
• USP <88> Class VI 121 °C
• TSE/BSE Certificate of Suitability
• cGMP
Devices with order code for "Test, certificate", option JG "Compliance with requirements
derived from cGMP, declaration" are in accordance with cGMP requirements relating
to the surfaces of wetted parts, design, FDA 21 CFR material conformity, USP Class VI
tests and TSE/BSE-compliance.
A manufacturer's declaration specific to the serial number is supplied with the device.
Pressure Equipment
Directive
• With the identification PED/G1/x (x = category) on the sensor nameplate,
Hauser confirms conformity with the "Essential Safety Requirements" specified
in Appendix I of the Pressure Equipment Directive 2014/68/EU.
• Devices not bearing this marking (PED) are designed and manufactured according to
good engineering practice. They meet the requirements of Article 4 paragraph 3 of the
Pressure Equipment Directive 2014/68/EU. The range of application is indicated in
tables 6 to 9 in Annex II of the Pressure Equipment Directive 2014/68/EU.
Radio approval
The measuring device has radio approval.
For detailed information regarding radio approval, see Special Documentation
Additional certification
CRN approval
Some device versions have CRN approval. A CRN-approved process connection with a CSA
approval must be ordered for a CRN-approved device.
Tests and certificates
• EN10204-3.1 material certificate, parts and sensor housing in contact with medium
• Pressure testing, internal procedure, inspection certificate
• PMI test (XRF), internal procedure, wetted parts, test report
• Compliance with requirements derived from cGMP, Declaration
• EN10204-2.1 confirmation of compliance with the order and EN10204-2.2 test report
Other standards and
guidelines
• EN 60529
Degrees of protection provided by enclosures (IP code)
• IEC/EN 60068-2-6
Environmental influences: Test procedure - Test Fc: vibrate (sinusoidal).
• IEC/EN 60068-2-31
Environmental influences: Test procedure - Test Ec: shocks due to rough handling,
primarily for devices.
• EN 61010-1
Safety requirements for electrical equipment for measurement, control and laboratory
use - general requirements
• IEC/EN 61326
Emission in accordance with Class A requirements. Electromagnetic compatibility (EMC
requirements).
• NAMUR NE 21
Electromagnetic compatibility (EMC) of industrial process and laboratory control
equipment
• NAMUR NE 32
Data retention in the event of a power failure in field and control instruments with
microprocessors