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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
31-Aug-2016
Completion Date
31-Aug-2016

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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.

---------------------- Page: 1 ----------------------

SIST EN ISO 7864:2016

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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
...

SLOVENSKI STANDARD
oSIST prEN ISO 7864:2015
01-marec-2015
Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode
(ISO/DIS 7864:2014)
Sterile hypodermic needles for single use - Requirements and test methods (ISO/DIS
7864:2014)
Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren
(ISO/DIS 7864:2014)
Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai
(ISO/DIS 7864:2014)
Ta slovenski standard je istoveten z: prEN ISO 7864 rev
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7864:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 7864:2015

---------------------- Page: 2 ----------------------
oSIST prEN ISO 7864:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7864
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2014-12-04 2015-05-04
Sterile hypodermic needles for single use — Requirements
and test methods
Aiguilles hypodermiques stériles, non réutilisables
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7864:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014

---------------------- Page: 3 ----------------------
oSIST prEN ISO 7864:2015
ISO/DIS 7864:2014(E)

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 7864:2015
ISO/DIS 7864
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 General . 2
4.2 Statistics and reproducibility of test methods . 2
4.3 Cleanliness .
...

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