ISO/PRF 8362-2
(Main)Injection containers and accessories — Part 2: Closures for injection vials
Injection containers and accessories — Part 2: Closures for injection vials
ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in ISO 8362-2:2015 are intended for single use only.
Récipients et accessoires pour produits injectables — Partie 2: Bouchons pour flacons
L'ISO 8362-2:2015 spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons de flacons pour produits injectables faisant l'objet de l'ISO 8362‑1 et de l'ISO 8362‑4. Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur. Les bouchons faisant l'objet de l'ISO 8362-2:2015 sont à usage unique.
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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 .
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Date: 2024-01-04 Style Definition
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ISO/PRF 8362-2:2024(E)
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ISO/TC 76
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Secretariat: DIN
Date: 2024-02-01
Injection containers and accessories —
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Part 2: Closure
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Closures for injection vials
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Élément introductif — Récipients et accessoires pour produits injectable — injectables — Formatted: French (France)
Partie 2: Bouchons pour flacons Formatted: French (France)
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PROOF
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ISO/PRF 8362-2:2024(Een)
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© ISO 2024
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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.
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ii © ISO 2024 – All rights reserved
© ISO 2024 – All rights reserved
ii
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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 .
...
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