EN ISO 9626:2016

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.
It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.
It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten - Anforderungen und Prüfverfahren (ISO 9626:2016)

Die vorliegende Internationale Norm gilt für biegesteife Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Injektionskanülen und anderen Medizinprodukten, vorwiegend für die Anwendung am Menschen.
Diese Internationale Norm enthält Anforderungen an und Prüfverfahren für Rohre, die in Form von Kanülen für den Einsatz als Komponenten in Medizinprodukten hergestellt werden. Eine zusätzliche Leistungsprüfung der Rohre kann erforderlich werden, wenn die Komponente in das gebrauchsfertige Produkt integriert wird.
Diese Internationale Norm legt die Maße und mechanischen Eigenschaften von Kanülenrohren aus Stahl der metrischen Nenngrößen von 3,4 mm (10 Gauge) bis 0,18 mm (34 Gauge) fest.
Sie gilt nicht für flexible Kanülenrohre aus nichtrostendem Stahl, da deren mechanische Eigenschaften von den in dieser Internationalen Norm für biegesteife Rohre festgelegten Eigenschaften abweichen. Hersteller und Käufer von flexiblen Kanülenrohren sind jedoch angehalten, die maßbezogenen Spezifikationen dieser Internationalen Norm anzuwenden.

Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical - Exigences et méthodes d'essai (ISO 9626:2016)

L'ISO 9626 :2016 est applicable aux tubes d'aiguilles rigides en acier inoxydable pouvant être utilisés dans la fabrication des aiguilles hypodermiques et d'autres dispositifs médicaux principalement à usage humain.
Elle prescrit des exigences et des méthodes d'essai s'appliquant aux tubes utilisés pour la fabrication d'aiguilles de dispositifs médicaux. Des essais de performance complémentaires concernant l'aspect du tube peuvent être requis lorsque l'élément est intégré dans le dispositif prêt à l'emploi.
Elle prescrit les dimensions et les propriétés mécaniques des tubes en acier de dimensions théoriques 3,4 mm (10 ga) à 0,18 mm (34 ga).
Elle n'est pas applicable aux tubes flexibles en acier inoxydable du fait que leurs propriétés mécaniques diffèrent de celles prescrites pour les tubes rigides dans l'ISO 9626 :2016. Toutefois, les fabricants et acheteurs de tubes flexibles sont invités à adopter les spécifications dimensionnelles indiquées dans l'ISO 9626 :2016.

Igle iz nerjavnega jekla za izdelavo medicinskih pripomočkov - Zahteve in preskusne metode (ISO 9626:2016)

Ta mednarodni standard se uporablja za toge nerjavne cevi za igle, primerne za uporabo pri izdelavi podkožnih igel in drugih medicinskih pripomočkov predvsem za uporabo pri ljudeh.
Ta mednarodni standard določa zahteve in preskusne metode za cevi, izdelane za igle kot komponente, uporabljene pri medicinskih pripomočkih. Dodatno preskušanje zmogljivosti cevi se lahko zahteva, ko je komponenta dodana v napravo, pripravljeno za uporabo.
Ta mednarodni standard določa mere in mehanske lastnosti nerjavnih cevi
z metrično označbo velikosti od 3,4 mm (10 gauge) do 0,18 mm (34 gauge).
Ne uporablja se za prožne nerjavne cevi, ker se njihove mehanske lastnosti razlikujejo od tistih, določenih za toge cevi v tem standardu. Kljub temu se proizvajalce in kupce prožnih cevi spodbuja, da sprejmejo dimenzijske specifikacije, določene v tem mednarodnem standardu.

General Information

• Status: Published
• Publication Date: 30-Aug-2016
• Withdrawal Date: 27-Feb-2017
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 31-Aug-2016
• Completion Date: 31-Aug-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 9626:2016 - Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

Relations

• Replaces: EN ISO 9626:1995/A1:2001 - Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991/AM 1:2001)
• Effective Date: 07-Sep-2016
• Replaces: EN ISO 9626:1995 - Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991)
• Effective Date: 18-Jan-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9626:2016
01-november-2016
1DGRPHãþD
SIST EN ISO 9626:2000
SIST EN ISO 9626:2000/A1:2002
,JOHL]QHUMDYQHJDMHNOD]DL]GHODYRPHGLFLQVNLKSULSRPRþNRY=DKWHYHLQ
SUHVNXVQHPHWRGH,62
Stainless steel needle tubing for the manufacture of medical devices - Requirements and
test methods (ISO 9626:2016)
Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten (ISO
9626:2016)
Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical - Exigences
et méthodes d'essai (ISO 9626:2016)
Ta slovenski standard je istoveten z: EN ISO 9626:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 9626:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9626:2016

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SIST EN ISO 9626:2016


EN ISO 9626
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2016
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 9626:1995
English Version

Stainless steel needle tubing for the manufacture of
medical devices - Requirements and test methods (ISO
9626:2016)
Tubes d'aiguilles en acier inoxydable pour la Kanülenrohre aus nichtrostendem Stahl zur
fabrication de matériel médical - Exigences et Herstellung von Medizinprodukten - Anforderungen
méthodes d'essai (ISO 9626:2016) und Prüfverfahren (ISO 9626:2016)
This European Standard was approved by CEN on 12 June 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9626:2016 E
worldwide for CEN national Members.

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SIST EN ISO 9626:2016
EN ISO 9626:2016 (E)
Contents Page
European foreword . 3

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SIST EN ISO 9626:2016
EN ISO 9626:2016 (E)
European foreword
This document (EN ISO 9626:2016) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and catheters" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2017, and conflicting national standards
shall be withdrawn at the latest by February 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 9626:1995.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9626:2016 has been approved by CEN as EN ISO 9626:2016 without any modification.
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SIST EN ISO 9626:2016

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SIST
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