About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | EN ISO 8362-2:2024 |
|---|---|
| Title | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024) |
| Work Item Number | CSS02045 |
| Abstract/Scope | This document 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 this document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging. |
| Status |
Published
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| Reference Document |
ISO 8362-2:2024 (EQV)
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| date of Availability (DAV) | 2024-04-03 |
| ICS | 11.040.20 - Transfusion, infusion and injection equipment |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | |
|---|---|
| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2023-12-21 |
|---|---|
| date of Availability (DAV) (2) | 2024-04-03 |
| date of Announcement (DOA) (3) | 2024-07-31 |
| date of Publication (DOP) (4) | 2024-10-31 |
| date of Withdrawal (DOW) (5) | 2024-10-31 |
Relations
| Supersedes |
EN ISO 8362-2:2015/A1:2022
EN ISO 8362-2:2015 |
|---|---|
| Superseded by | |
| Normative reference (6) |
ISO 3302-1
ISO 3302-2 ISO 48-4 ISO 8362-1 ISO 8362-4 ISO 8871-1 ISO 8871-4 ISO 8871-5:2016
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| Sales Points |
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.