SSH EN 16821:2017

Tuba gome dhe bashkues tubash plastik për përdorim në industrinë farmaceutike dhe bioteknologjike - Tuba gome të përbëre nga silikoni

Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hoses

Scope

This final draft European Standard applies to type 1 to type 3 hose assemblies with hoses made of silicone rubber for the transport of liquid or powdery substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −40 °C ) to +150 °C and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Table 1). These hose assemblies are not electrically conductive. The danger of static charging shall be considered on a case-by-case basis.
Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.2).
Attention is called to the fact that for certain applications the relevant legal regulations such as the Pressure Equipment Directive 2014/68/EU (PED) need to be complied with.