EN ISO 7864:2016

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren (ISO 7864:2016)

Diese Internationale Norm legt Anforderungen an sterile Injektionskanülen zum Einmalgebrauch der metrischen Nenngrößen von 0,18 mm bis 1,2 mm fest.
Sie gilt nicht für jene medizinischen Artikel, die in ihren eigenen Normen behandelt werden, wie Dentalkanülen und Pen-Nadeln.

Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai (ISO 7864:2016)

L'ISO 7864 :2016 fixe les prescriptions des aiguilles hypodermiques stériles, non réutilisables, ayant des dimensions métriques désignées comprises entre 0,18 mm et 1,2 mm.
Elle ne s'applique pas aux dispositifs couverts par leur propre norme, tels que les aiguilles dentaires et les aiguilles à stylo.

Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode (ISO 7864:2016)

Ta mednarodni standard določa zahteve za sterilne podkožne igle za enkratno uporabo
z metrično označbo velikosti od 0,18 mm do 1,2 mm.
Ne uporablja se za naprave, ki so obravnavane v svojih standardih, kot so zobozdravniške igle in
igle za peresnike.

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 7864:2016 - Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

Relations

• Replaces: EN ISO 7864:1995 - Sterile hypodermic needles for single use (ISO 7864:1993)
• Effective Date: 18-Jan-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7864:2016
01-november-2016
1DGRPHãþD
SIST EN ISO 7864:2000
Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode (ISO
7864:2016)
Sterile hypodermic needles for single use - Requirements and test methods (ISO
7864:2016)
Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren
(ISO 7864:2016)
Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai (ISO
7864:2016)
Ta slovenski standard je istoveten z: EN ISO 7864:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7864:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7864:2016

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SIST EN ISO 7864:2016


EN ISO 7864
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2016
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7864:1995
English Version

Sterile hypodermic needles for single use - Requirements
and test methods (ISO 7864:2016)
Aiguilles hypodermiques stériles, non réutilisables - Sterile Injektionskanülen für den Einmalgebrauch -
Exigences et méthodes d'essai (ISO 7864:2016) Anforderungen und Prüfverfahren (ISO 7864:2016)
This European Standard was approved by CEN on 15 July 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 7864:2016 E
worldwide for CEN national Members.

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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2

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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
European foreword
This document (EN ISO 7864:2016) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection, and blood processing equipment for medical and pharmaceutical use" 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 7864:1995.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevan
...