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EN 16821:2017

Current

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

Published date

14-06-2017

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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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