Samson 3349, Mounting And Operating Instructions

Page: 79 / 104

EB 8048-2 EN 14-5
SAMSON REGULATION S.A.S. · 1, rue Jean Corona · 69120 Vaulx-en-Velin, France · samson@samsongroup.com 3
EU DECLARATION OF CONFORMITY DC005
For the following product 2021-09
Aseptic Angle Valve Type 3349
The Aseptic Angle Valve Type 3349 meets the requirements of the food and pharmaceutical industry.
The valve components in contact with foodstuffs meet the following requirements:
- the metal parts (valve body and plug) are made of forged stainless steel 1.4435/316L in accord-
ance with:
o the French decree of 13 January 1976 on stainless steel materials and objects in contact
with foodstuffs;
o
the sheet published by the French authority DGCCRF: MCDA n°1 (V2 - 2017), Aptitude
for food contact of metals and metal alloys intended to come into contact with foodstuffs.
- The diaphragm, which ensures the seal with the outside, is made of PTFE:
o Our supplier's declaration of conformity certifies that this material complies with regula-
tions (EC) No. 1935/2004 4 and (EU) No. 10/2011 5 as amended and is manufactured in
accordance with the good manufacturing practices established by regulation (EC) No.
2023/2006
6
;
o The conditions and results of the overall and specific migration tests are detailed on the
next page.
- The optional valve seals, which provide the internal seal, are made of PEEK Natural Food & Life
Science Grade:
o Our supplier's declaration of conformity certifies that this material complies with regula-
tions (EC) No. 1935/2004
4
and (EU) No. 10/2011
5
as amended and is manufactured in
accordance with the good manufacturing practices established by regulation (EC) No.
2023/2006 6 ;
o The conditions and results of our supplier's global and specific migration tests are availa-
ble on request.
According to the migration tests carried out on the plastic components in accordance with Regulation
(EU) No 10/2011 as amended, the overall and specific migrations remain within the limits set by the
above-mentioned Regulation when the complete apparatus is used under the conditions indicated below:
- for all foodstuffs specified due to the satisfactory results obtained with simulants A, B and D2 (Annex III
Tables 1 and 3);
- under the conditions covered by the tests: applications at a maximum temperature of 121°C (according
to Annex V Chapter 3 Table 3).
4
Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food
5
Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as last amended by Regula-
tion (EU) No 2020/1245
6
Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food