EN 16821:2017
Current
The latest, up-to-date edition.
Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Silicone rubber hoses
06-14-2017
European foreword
1 Scope
2 Normative references
3 Classifications and conditions of use
4 Dimensions
5 Materials
6 Requirements and tests - Physical properties
7 Designs/types of connection
8 Manufacturing of the hose assembly
9 Frequency of testing
10 Marking
11 Installation and user instructions
12 Storage and permissible storage time
Annex A (normative) - Surface roughness and
design of hose couplings
Annex B (normative) - Test frequencies for
type tests and routine tests
Annex C (informative) - Production acceptance tests
Bibliography
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.
Committee |
CEN/TC 218
|
DevelopmentNote |
Supersedes PREN 16821. (06/2017)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
DIN EN 16821:2015-03 (Draft) | Identical |
BS EN 16821:2017 | Identical |
NS EN 16821 : 2017 | Identical |
SN EN 16821 : 2017 | Identical |
NEN EN 16821 : 2017 | Identical |
DIN EN 16821:2017-10 | Identical |
UNI EN 16821 : 2017 | Identical |
PN EN 16821 : 2017 | Identical |
I.S. EN 16821:2017 | Identical |
UNE-EN 16821:2018 | Identical |
NF EN 16821 : 2017 | Identical |
EN ISO 5817:2014 | Welding - Fusion-welded joints in steel, nickel, titanium and their alloys (beam welding excluded) - Quality levels for imperfections (ISO 5817:2014) |
EN ISO 7233:2016 | Rubber and plastics hoses and hose assemblies - Determination of resistance to vacuum (ISO 7233:2016) |
EN ISO 1402:2009 | Rubber and plastics hoses and hose assemblies - Hydrostatic testing (ISO 1402:2009) |
ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) |
ISO 7233:2016 | Rubber and plastics hoses and hose assemblies Determination of resistance to vacuum |
EN 10088-2:2014 | Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes |
ISO 8331:2016 | Rubber and plastics hoses and hose assemblies Guidelines for selection, storage, use and maintenance |
EN ISO 7326:2016 | Rubber and plastics hoses - Assessment of ozone resistance under static conditions (ISO 7326:2016) |
ISO 7326:2016 | Rubber and plastics hoses Assessment of ozone resistance under static conditions |
ISO 5817:2014 | Welding — Fusion-welded joints in steel, nickel, titanium and their alloys (beam welding excluded) — Quality levels for imperfections |
ISO 10619-1:2011 | Rubber and plastics hoses and tubing Measurement of flexibility and stiffness Part 1: Bending tests at ambient temperature |
ISO 2078:1993 | Textile glass Yarns Designation |
ISO 10619-2:2011 | Rubber and plastics hoses and tubing Measurement of flexibility and stiffness Part 2: Bending tests at sub-ambient temperatures |
EN 10204:2004 | Metallic products - Types of inspection documents |
EN ISO 8331:2016 | Rubber and plastics hoses and hose assemblies - Guidelines for selection, storage, use and maintenance (ISO 8331:2016) |
2014/68/EU : 2014 COR 1 2015 | DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 MAY 2014 ON THE HARMONISATION OF THE LAWS OF THE MEMBER STATES RELATING TO THE MAKING AVAILABLE ON THE MARKET OF PRESSURE EQUIPMENT TEXT WITH EEA RELEVANCE |
ISO 7619-2:2010 | Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 2: IRHD pocket meter method |
ISO 1402:2009 | Rubber and plastics hoses and hose assemblies Hydrostatic testing |
ISO 1043-1:2011 | Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics |
ISO 1629:2013 | Rubber and latices — Nomenclature |
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