ISO 8362-2:2024

Norme
internationale
ISO 8362-2
Quatrième édition
Récipients et accessoires pour
2024-03
produits injectables —
Partie 2:
Bouchons pour flacons
Injection containers and accessories —
Part 2: Closures for injection vials
Numéro de référence
ISO 8362-2:2024(fr) © ISO 2024

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ISO 8362-2:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse

© ISO 2024 – Tous droits réservés
ii

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ISO 8362-2:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Classification . 2
5 Forme et dimensions . 2
6 Désignation . 4
7 Matériau . 4
8 Exigences de fonctionnement . . 4
8.1 Généralités .4
8.2 Exigences physiques .5
8.2.1 Dureté .5
8.2.2 Pénétrabilité .5
8.2.3 Fragmentation .5
8.2.4 Auto-obturation et essai relatif à l’étanchéité à la solution aqueuse .5
8.2.5 Étanchéité à la solution aqueuse .5
8.2.6 Résistance au vieillissement .
...

International
Standard
ISO 8362-2
Fourth edition
Injection containers and
accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
PROOF/ÉPREUVE
Reference number
ISO 8362-2:2024(en) © ISO 2024

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ISO 8362-2:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
PROOF/ÉPREUVE
© ISO 2024 – All rights reserved
ii

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ISO 8362-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 4
7 Material. 4
8 Performance requirements . . 4
8.1 General .4
8.2 Physical requirements .5
8.2.1 Hardness .5
8.2.2 Penetrability . . .5
8.2.3 Fragmentation .5
8.2.4 Self-sealing and aqueous solution tightness test .5
8.2.5 Aqueous solution tightness .5
8.2.6 Resistance to ageing .
...

Date: 2024-01-04 Style Definition
...
Formatted: Left: 42.55 pt, Right: 42.55 pt, Top: 39.7 pt,
Gutter: 0 pt, Section start: New page, Header distance from
ISO/PRF 8362-2:2024(E)
edge: 36 pt, Footer distance from edge: 36 pt
Formatted: zzCover large, Adjust space between Latin and
ISO/TC 76
Asian text, Adjust space between Asian text and numbers
Secretariat: DIN
Date: 2024-02-01
Injection containers and accessories —
Formatted: Cover Title_A2, Adjust space between Latin and
Part 2: Closure
Asian text, Adjust space between Asian text and numbers
Closures for injection vials
Formatted: Regular, Font: 16 pt, Bold
Élément introductif — Récipients et accessoires pour produits injectable — injectables — Formatted: French (France)
Partie 2: Bouchons pour flacons Formatted: French (France)
Formatted: Cover Title_B, Adjust space between Latin and
Asian text, Adjust space between Asian text and numbers
PROOF

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ISO/PRF 8362-2:2024(Een)
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Formatted: Font: 11 pt, Bold
Formatted: Font: Bold
© ISO 2024
Formatted: HeaderCentered
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
Formatted: French (Switzerland)
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
Formatted: Adjust space between Latin and Asian text,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
Adjust space between Asian text and numbers
at the address below or ISO'sISO’s member body in the country of the requester.
Formatted: Default Paragraph Font, French (Switzerland)
Formatted: French (Switzerland)
ISO Copyright Officecopyright office
CP 401 • Ch. de Blandonnet 8
Formatted: Default Paragraph Font, French (Switzerland)
CH-1214 Vernier, Geneva
Formatted: French (Switzerland)
Phone: + 41 22 749 01 11
Formatted: zzCopyright address, Adjust space between
Latin and Asian text, Adjust space between Asian text and
Email: copyright@iso.org
Formatted: French (Switzerland)
E-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org Formatted: zzCopyright address, Adjust space between
Latin and Asian text, Adjust space between Asian text and
Published in Switzerland.
Formatted: FooterPageRomanNumber
ii © ISO 2024 – All rights reserved
© ISO 2024 – All rights reserved

ii

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Formatted: Font: 11 pt, Bold
ISO/PRF 8362-2:2024(Een)
Formatted: HeaderCentered, Left
Formatted: Font: 11 pt, Bold
Formatted: Font: 11 pt, Bold
Contents Page
Formatted: Font: Bold
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 5
7 Material . 5
8 Performance requirements . 6
8.1 General . 6
8.2 Physical requirements . 6
8.2.1 Hardness .
...