ISO 8362-1:2003/FDAmd 1
(Amendment)Injection containers and accessories — Part 1: Injection vials made of glass tubing — Amendment 1
Injection containers and accessories — Part 1: Injection vials made of glass tubing — Amendment 1
Récipients et accessoires pour produits injectables — Partie 1: Flacons en verre étiré — Amendement 1
General Information
Relations
Standards Content (Sample)
FINAL ISO
AMENDMENT
DRAFT 8362-1:2003
FDAM 1
ISO/TC 76
Injection containers and accessories —
Secretariat: DIN
Part 1:
Voting begins on:
2008-09-16
Injection vials made of glass tubing
Voting terminates on:
AMENDMENT 1
2008-11-16
Récipients et accessoires pour produits injectables —
Partie 1: Flacons en verre étiré
AMENDEMENT 1
Please see the administrative notes on page iii
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 SUPPORT-
ING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO 8362-1:2003/FDAM 1:2008(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2008
---------------------- Page: 1 ----------------------
ISO 8362-1:2003/FDAM 1:2008(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2008 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8362-1:2003/FDAM 1:2008(E)
In accordance with the provisions of Council Resolution 15/1993, this document is circulated in the
English language only.
© ISO 2008 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 8362-1:2003/FDAM 1:2008(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to ISO 8362-1:2003 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion
and injection equipment for medical and pharmaceutical use.
The purpose of this Amendment is to develop further types of neck finishes for injection vials (model B and
model C) in order to meet the market actualities.
iv © ISO 2008 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 8362-1:2003/FDAM 1:2008(E)
Injection containers and accessories —
Part 1:
Injection vials made of glass tubing
AMENDMENT 1
Page 1, Dimensions
Replace the first paragra
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.