EN 13348:2016

Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum

This European Standard specifies the requirements, sampling, test methods and conditions of delivery for copper tubes.
It is applicable to seamless round copper tubes having an outside diameter from 6 mm up to and including 219 mm for pipeline systems under vacuum or for distributing the following medical gases intended to be used at operating pressures up to 2 000 kPa:
-   oxygen, nitrous oxide, nitrogen, helium, carbon dioxide, xenon;
-   medical air;
-   specific mixtures of these above mentioned gases;
-   air for driving surgical tools;
-   anaesthetic gases and vapours.

Kupfer und Kupferlegierungen - Nahtlose Rundrohre aus Kupfer für medizinische Gase oder Vakuum

Diese Europäische Norm legt die Anforderungen, Probenentnahme, Prüfverfahren und die Liefer-bedingungen für Rohre aus Kupfer fest.
Sie gilt für nahtlose Rundrohre aus Kupfer, die einen Außendurchmesser von 6 mm bis 219 mm haben und die für Rohrleitungssysteme unter Vakuum und zur Verteilung der folgenden medizinischen Gase bei Arbeitsdrücken bis 2 000 kPa vorgesehen sind:
   Sauerstoff, Stickstoffoxide, Stickstoff, Helium, Kohlenstoffdioxid, Xenon;
   medizinische Luft;
   spezifische Mischungen aus den oben erwähnten Gasen;
   Luft zum Antrieb chirurgischer Instrumente;
Gase und Dämpfe für die Anästhesie.

Cuivre et alliages de cuivre - Tubes ronds sans soudure en cuivre pour gaz médicaux ou le vide

La présente Norme européenne établit les exigences, le mode d'échantillonnage, les méthodes d'essai et les conditions de livraison applicables aux tubes en cuivre.
Elle s'applique aux tubes ronds sans soudure en cuivre de diamètre extérieur compris entre 6 mm et 219 mm inclus, destinés à des réseaux de distribution par canalisations sous vide ou à la distribution des gaz médicaux suivants prévus pour être utilisés à des pressions de service pouvant atteindre 2 000 kPa :
-   l'oxygène, le protoxyde d'azote, l'azote, l'hélium, le dioxyde de carbone, le xénon ;
-   l’air à usage médical ;
-   les mélanges spécifiques des gaz spécifiés ci-avant ;
-   l'air permettant d'actionner les instruments chirurgicaux ;
-   les gaz et vapeurs anesthésiques.

Baker in bakrove zlitine - Nevarjene okrogle bakrene cevi za medicinske pline ali vakuumske sisteme

Ta evropski standard določa tolerance mer in oblike za hladno vlečene nevarjene cevi iz aluminija in aluminijeve zlitine z zunanjim premerom (OD) od 3 mm do 350 mm (okrogla cev, glej sliko 1) ali s presekom v odprtini (CD) velikosti od 8 mm do 300 mm (neokrogla cev, glej sliko 2), dobavljene v ravnih presekih.
Ta evropski standard se uporablja samo za cevi, izdelane z metodo iztiskovanja s celim utopom/trnom (ki so nato hladno vlečene do zahtevane končne mere).
Oznake za popuščanje, uporabljene v tem delu, so skladne s standardom EN 515.
Ta dokument se uporablja za hladno vlečene nevarjene cevi za splošno tehnično uporabo.
Ta dokument se ne uporablja za:
– hladno vlečene cevi, izdelane z metodo iztiskovanja z večdelnimi matricami/mostičkom (EN 754-8),
– cevi, dobavljene v navojih (EN 13958),
– navojne cevi, razrezane po dolžini (EN 13958).

General Information

• Status: Published
• Publication Date: 14-Jun-2016
• Withdrawal Date: 30-Dec-2016
• ICS: 23.040.15 - Non-ferrous metal pipes
• Technical Committee: CEN/TC 133 - Copper and copper alloys
• Drafting Committee: CEN/TC 133/WG 3 - Copper tubes (installation and industrial)
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 19-Oct-2022
• Completion Date: 22-Apr-2026
• Directive: Harmonized Standard2014/68/EU - 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
  OJ Ref: C 293/01 OJ Date: 12-Aug-2016
• Directive:

  ---

  Not Harmonized97/23/EC - Pressure equipment
• Mandate: M/071 - Mandate to CEN for standardization in the field of Pressure equipment
• Ref Project: SIST EN 13348:2016 - Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum

Relations

• Replaces: EN 13348:2008 - Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
• Effective Date: 12-Dec-2012
• Refers: ISO 4741:1984 - Copper and copper alloys — Determination of phosphorus content — Molybdovanadate spectrometric method
• Effective Date: 22-Apr-2026
• Refers: ISO 1553:1976 - Unalloyed copper containing not less than 99,90 % of copper — Determination of copper content — Electrolytic method
• Effective Date: 22-Apr-2026
• Refers: EN 1971-1:2019 - Copper and copper alloys - Eddy current test for measuring defects on seamless round copper and copper alloy tubes - Part 1: Test with an encircling test coil on the outer surface
• Effective Date: 28-Jan-2026
• Refers: EN ISO 8493:2004 - Metallic materials - Tube - Drift-expanding test (ISO 8493:1998)
• Effective Date: 28-Jan-2026
• Refers: EN ISO 6892-1:2019 - Metallic materials - Tensile testing - Part 1: Method of test at room temperature (ISO 6892-1:2019)
• Effective Date: 28-Jan-2026
• Refers: EN 723:2009 - Copper and copper alloys - Combustion method for determination of the carbon content on the inner surface of copper tubes or fittings
• Effective Date: 28-Jan-2026
• Refers: EN 10204:2004 - Metallic products - Types of inspection documents
• Effective Date: 28-Jan-2026
• Refers: EN ISO 6507-1:2023 - Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2023)
• Effective Date: 28-Jan-2026
• Refers: EN 1971-2:2019 - Copper and copper alloys - Eddy current test for measuring defects on seamless round copper and copper alloy tubes - Part 2: Test with an internal probe on the inner surface
• Effective Date: 28-Jan-2026
• Refers: ENV 1852-2:2000 - Plastics piping systems for non-pressure underground drainage and sewerage - Polypropylene (PP) - Part 2: Guidance for the assessment of conformity
• Effective Date: 28-Jan-2026
• Refers: EN ISO 8491:2004 - Metallic materials - Tube (in full section) - Bend test (ISO 8491:1998)
• Effective Date: 28-Jan-2026
• Refers: EN 1173:2008 - Copper and copper alloys - Material condition designation
• Effective Date: 28-Jan-2026
• Refers: EN 12697-28:2000 - Bituminous mixtures - Test methods for hot mix asphalt - Part 28: Preparation of samples for determining binder content, water content and grading
• Effective Date: 28-Jan-2026
• Referred By: EN 14931:2006 - Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
• Effective Date: 28-Jan-2026

Overview

EN 13348:2016 is a harmonized European Standard developed by CEN for the specification of seamless, round copper tubes used in pipeline systems for medical gases or vacuum. Covering tubes with outside diameters from 6 mm up to and including 219 mm, the standard defines the requirements, test methods, sampling protocols, and delivery conditions. It applies to tubes designed to distribute medical gases and mixtures – such as oxygen, nitrous oxide, nitrogen, helium, carbon dioxide, xenon, medical air, anaesthetic gases, vapours, and air for driving surgical tools – at pressures up to 2,000 kPa or under vacuum.

This document is essential in ensuring copper tubing used within critical healthcare environments is manufactured to stringent quality, cleanliness, and safety criteria, complying with EU directives such as the Pressure Equipment Directive (PED, 2014/68/EU).

Key Topics

EN 13348:2016 covers the following core aspects:

• Material and Compositional Requirements
  Specifies copper composition (minimum Cu + Ag) and material conditions (e.g., R220 - annealed, R250 - half hard, R290 - hard).
• Mechanical and Dimensional Properties
  Sets values for tensile strength, elongation, nominal diameters, wall thicknesses, and tolerances for seamless copper tubes.
• Surface Quality and Cleanliness
  Demands smooth, clean, contamination-free inner and outer tube surfaces – with strict limits for lubricant residue to ensure hygienic gas delivery.
• Testing and Inspection
  Details mandatory tests such as eddy current testing, hydrostatic and pneumatic tests, and carbon content checks to verify tube integrity, defect freedom, and internal cleanliness.
• Marking, Packaging, and Documentation
  Requires permanent or durable marking of each tube, secure capping to maintain cleanliness, and proper documentation per EN 10204 inspection requirements.
• Sampling and Quality Control
  Establishes batch-based sampling rates, aligning with recognized quality management systems, such as EN ISO 9001.

Applications

Copper tubes conforming to EN 13348:2016 are primarily specified for:

• Medical Gas Pipeline Systems
  Used in hospitals, dental surgeries, and healthcare facilities for conveying critical medical gases (oxygen, nitrous oxide, etc.) and vacuum.
• Vacuum Installations
  Essential for the distribution of vacuum in surgery or intensive care environments.
• Air Lines for Surgery
  Suited for supplying compressed air for driving surgical instruments.
• Anaesthetic Gas Distribution
  Safe for delivering controlled anaesthetic gases and vapours within clinical settings.
• Compliance with Regulatory Requirements
  Adoption of EN 13348 is a key assurance for meeting EU safety, hygiene, and performance legislative requirements for systems delivering breathable gases.

The standard ensures compatibility with various installation methods, including soldering, brazing, or mechanical joining, supporting safe and efficient installation practices.

Related Standards

Organizations involved with medical gas and vacuum installations may also need to reference these related documents:

• EN 1057: Copper tubes for water and gas in sanitary and heating applications
• EN 12449 / EN 12450 / EN 12451 / EN 12452: Copper and copper alloy tubes for general, capillary, and heat exchanger applications
• EN 12735 (Parts 1 and 2): Copper tubes for air conditioning and refrigeration
• EN 13349: Pre-insulated copper tubes
• EN ISO 7396-1 / 7396-2: Medical gas pipeline and anaesthetic gas scavenging systems
• EN ISO 9001: Quality management systems
• Directive 2014/68/EU (PED): European Pressure Equipment Directive

For organizations looking to ensure the highest level of materials safety, quality assurance, and regulatory compliance in healthcare environments, EN 13348:2016 provides the definitive requirements for copper tubes in medical gas and vacuum systems.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Baker in bakrove zlitine - Nevarjene okrogle bakrene cevi za medicinske pline ali vakuumske sistemeKupfer und Kupferlegierungen - Nahtlose Rundrohre aus Kupfer für medizinische Gase oder VakuumCuivre et alliages de cuivre - Tubes ronds sans soudure en cuivre pour gaz médicaux ou le videCopper and copper alloys - Seamless, round copper tubes for medical gases or vacuum77.150.30Bakreni izdelkiCopper products23.040.15Cevi iz neželeznih kovinNon-ferrous metal pipesICS:Ta slovenski standard je istoveten z:EN 13348:2016SIST EN 13348:2016en,fr,de01-september-2016SIST EN 13348:2016SLOVENSKI
STANDARDSIST EN 13348:20081DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13348
June
t r s x ICS
t uä r v rä s w Supersedes EN
s u u v zã t r r zEnglish Version
Copper and copper alloys æ Seamlessá round copper tubes for medical gases or vacuum Cuivre et alliages de cuivre æ Tubes ronds sans soudure en cuivre pour gaz médicaux ou le vide
Kupfer und Kupferlegierungen æ Nahtlose Rundrohre aus Kupfer für medizinische Gase oder Vakuum This European Standard was approved by CEN on
t z February
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s u u v zã t r s x ESIST EN 13348:2016

Marking durability test . 18 A.1 Abrasion test . 18 A.2 Climatic test . 18 Annex B (normative)
Freedom from defects test . 19 B.1 Eddy current test . 19 B.2 Hydrostatic test . 19 B.3 Pneumatic test . 20 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of Directive 2014/68/EU aimed to be covered . 21 Bibliography . 22 Tables Table 1 — Mechanical properties . 10 Table 2 — Nominal outside diameters and wall thicknesses . 11 Table 3 — Tolerances on outside diameter . 12 Table 4 — Tolerance on wall thickness . 12 Table 5 — Lubricant residue on the inner surface of the tube . 13 Table 6 — Testing of bending and drift expanding . 14 Table 7 — Sampling rate . 14 Table 8 — Minimum radius of curvature . 15 Table 9 — Recommended form of delivery. 17 Table B.1 — Maximum drill diameters for the reference standard tube . 19 Table B.2 — Hydrostatic pressure test . 19 Table ZA.1 — Correspondence between this European Standard and Annex I of Directive 2014/68/EU . 21
EN 13348 — R290 — 12 × 1,0 Denomination
Number of this European Standard
Material condition designation
Nominal cross-sectional dimensions in millimetres
500 m Copper tube EN 13348 — R290 — 12 × 1,0 — 5 m straight lengths 6 Requirements 6.1 Composition The composition shall conform to the following requirements: Cu + Ag: min. 99,90 %; 0,015
¨
¶ P
¶
rá r v r %. This copper grade is designated either Cu-DHP or CW024A. 6.2 Mechanical properties The tensile strength and elongation shall conform to the requirements given in Table 1. The test shall be carried out in accordance with 8.2. SIST EN 13348:2016

mm MPa % HV 5 min. max. min. min.
R220 annealed 6 108 220 40 (40 to 70) R250 half harda 6 66,7 250 30 (75 to 100) 66,7 219 20 R290 harda 6 219 290 3 (min. 100)
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