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 3826-1:2019 |
|---|---|
| Title | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019) |
| Work Item Number | 00205327 |
| Abstract/Scope | This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units. Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter. |
| Status |
Published
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| Reference Document |
ISO 3826-1:2019 (EQV)
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| date of Availability (DAV) | 2019-10-16 |
| 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) | 2019-08-25 |
|---|---|
| date of Availability (DAV) (2) | 2019-10-16 |
| date of Announcement (DOA) (3) | 2020-01-31 |
| date of Publication (DOP) (4) | 2020-04-30 |
| date of Withdrawal (DOW) (5) | 2020-04-30 |
Relations
| Supersedes | EN ISO 3826-1:2013 |
|---|---|
| Superseded by | |
| Normative reference (6) |
ISO 10993-10
ISO 10993-11 ISO 10993-4 ISO 10993-5 ISO 1135-4 ISO 1135-5 ISO 3696 |
| Bibliographic references (7) | |
| 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.
(7) This list of bibliographic references, which is provided for homegrown standards only, is purely indicative and was retrieved automatically using available XML files. It is limited to publications that have been published in the XML format. For standards that are not homegrown, the corresponding international standard should be consulted.