Pharmaceutical Compatibility - Endress+Hauser Dosimass Modbus RS485 Operating Instructions Manual

Dosimass Modbus RS485
Hygienic compatibility
Pharmaceutical
compatibility
Pressure Equipment
Directive
4) DN 8 to 40 (³⁄₈ to 1 ½")
Endress+Hauser
• 3-A approval
• Only measuring devices with the order code for "Additional approval", option LP "3A"
have 3-A approval.
• The 3-A approval refers to the measuring device.
• When installing the measuring device, ensure that no liquid can accumulate on the
outside of the measuring device.
• Accessories (e.g. sensor holder) must be installed in accordance with the
3-A Standard.
Each accessory can be cleaned. Disassembly may be necessary under certain
circumstances.
4)
• EHEDG-certified
Only devices with the order code for "Additional approval", option LT "EHEDG" have been
tested and meet the requirements of the EHEDG.
To meet the requirements for EHEDG certification, the device must be used with process
connections in accordance with the EHEDG position paper entitled "Easy cleanable Pipe
couplings and Process connections" (www.ehedg.org).
When installed, the orientation of the device must facilitate draining in order to meet
the requirements of EHEDG certification.
• Food Contact Materials Regulation (EC) 1935/2004
Observe special mounting instructions →  21
• FDA 21 CFR 177
• USP <87>
• USP <88> Class VI 121 °C
• TSE/BSE Certificate of Suitability
• cGMP
Devices with the order code for "Test, certificate", option JG "Conformity with cGMP-
derived requirements, declaration" comply with the requirements of cGMP with regard to
the surfaces of parts in contact with the medium, design, FDA 21 CFR material
conformity, USP Class VI tests and TSE/BSE conformity.
A serial number-specific declaration is generated.
• With the marking
a) PED/G1/x (x = category) or
b) PESR/G1/x (x = category)
on the sensor nameplate, Endress+Hauser confirms compliance with the "Essential
Safety Requirements"
a) specified in Annex I of the Pressure Equipment Directive 2014/68/EU or
b) Schedule 2 of Statutory Instruments 2016 No. 1105.
• Devices not bearing this marking (without PED or PESR) are designed and manufactured
according to sound engineering practice. They meet the requirements of
a) Art. 4 Para. 3 of the Pressure Equipment Directive 2014/68/EU or
b) Part 1, Para. 8 of Statutory Instruments 2016 No. 1105.
The scope of application is indicated
a) in diagrams 6 to 9 in Annex II of the Pressure Equipment Directive 2014/68/EU or
b) Schedule 3, Para. 2 of Statutory Instruments 2016 No. 1105.
Technical data
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