Endress+Hauser Proline Promass E 500 PROFINET Operating Instructions Manual page 279

Proline Promass E 500 PROFINET
Pharmaceutical
compatibility
Certification PROFINET
Pressure Equipment
Directive
Radio approval
Additional certification
Other standards and
guidelines
Endress+Hauser
• FDA
• USP Class VI
• TSE/BSE Certificate of Suitability
• cGMP
Devices with the order code "Test, Certificate", option JG "Conformity to cGMP derived
requirements, declaration" meet the requirements of cGMP in regards of wetted parts
surface finish, design, FDA 21 CFR material compliance, USP Class VI testing, and
TSE/BSE compliance.
A serial number specific manufacturers declaration is delivered with the device.
PROFINET interface
The measuring device is certified and registered by the PNO (PROFIBUS User
Organization). The measuring system meets all the requirements of the following
specifications:
• Certified according to:
• Test specification for PROFINET devices
• PROFINET Security Level 2 – Netload Class
• The device can also be operated with certified devices of other manufacturers
(interoperability)
• The device supports PROFINET S2 system redundancy.
• With the identification PED/G1/x (x = category) on the sensor nameplate,
Endress+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.
The measuring device has radio approval.
For detailed information regarding radio approval, see Special Documentation
→  282
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
• EN10204-2.1 confirmation of compliance with the order and EN10204-2.2 test report
• 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.
Technical data
279