Endress+Hauser Proline Promass E 300 HART, Руководство по эксплуатации

Страница: 200 / 212

Technical data Proline Promass E 300 HART
200 Hauser
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.
Functional safety The measuring device can be used for flow monitoring systems (min., max., range) up to
SIL 2 (single-channel architecture; order code for "Additional approval", option LA) and SIL
3 (multichannel architecture with homogeneous redundancy) and is independently
evaluated and certified by the TÜV in accordance with IEC 61508.
The following types of monitoring in safety equipment are possible:
• Mass flow
• Volume flow
• Density
Functional Safety Manual with information on the SIL device →  203
HART certification HART interface
The measuring device is certified and registered by the FieldComm Group. The measuring
system meets all the requirements of the following specifications:
• Certified according to HART 7
• The device can also be operated with certified devices of other manufacturers
(interoperability)
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
→  204
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