EN ISO 6710:2017

Single-use containers for human venous blood specimen collection (ISO 6710:2017)

ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.
It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.

Gefäße zur einmaligen Verwendung für die venöse Blutentnahme beim Menschen (ISO 6710:2017)

Diese Internationale Norm legt Anforderungen an und Prüfungen für evakuierte und nicht evakuierte Probengefäße (-behälter) zur einmaligen Verwendung für die venöse Blutentnahme fest.
Sie legt keine Anforderungen an Blutentnahmekanülen, Kanülenhalter, Blutkulturgefäße oder Entnahme-vorrichtungen für arterielles Blutgas, die für venöses Blut verwendet werden dürfen, fest.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor dieser Norm.

Récipients à usage unique pour prélèvements de sang veineux humain (ISO 6710:2017)

L'ISO 6710 :2017 spécifie les exigences et les méthodes d'essai relatives aux récipients à usage unique pour prélèvements de sang veineux, sous vide ou non.
Il ne spécifie pas les exigences relatives aux aiguilles de prélèvement sanguin, aux supports d'aiguille, aux récipients pour hémoculture ou aux dispositifs de prélèvement de gaz du sang «artériel» pouvant aussi être utilisés pour le sang veineux.

Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi (ISO 6710:2017)

Ta dokument določa zahteve in preskusne metode za vsebnike za enkratno uporabo, ki jih je proizvajalec predvidel za zbiranje venske krvi iz človeškega telesa za namene diagnostičnih preiskav in vitro. Ta dokument se uporablja tudi za vsebnike, ki vsebujejo gojišča za krvne kulture.
Ta dokument ne določa zahtev za vsebnike kapilarne ali arterijske krvi. Ta dokument ne določa zahtev in preskusnih metod za vsebnike za enkratno uporabo, ki so namenjeni zbiranju nekrvnih vzorcev.

General Information

• Status: Published
• Publication Date: 05-Sep-2017
• Withdrawal Date: 05-Sep-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-Sep-2017
• Completion Date: 06-Sep-2017
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN ISO 6710:2017 - Single-use containers for venous blood specimen collection (ISO 6710:2017)

Relations

• Replaces: EN 14820:2004 - Single-use containers for human venous blood specimen collection
• Effective Date: 13-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 6710:2017
01-november-2017
1DGRPHãþD
SIST EN 14820:2005
Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi
(ISO 6710:2017)
Single-use containers for venous blood specimen collection (ISO 6710:2017)
Gefäße zur einmaligen Verwendung für die venöse Blutentnahme (ISO 6710:2017)
Récipients non réutilisables pour prélèvements de sang veineux (ISO 6710:2017)
Ta slovenski standard je istoveten z: EN ISO 6710:2017
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 6710:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 6710:2017

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SIST EN ISO 6710:2017


EN ISO 6710
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2017
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN 14820:2004
English Version

Single-use containers for human venous blood specimen
collection (ISO 6710:2017)
Récipients non réutilisables pour prélèvements de Gefäße zur einmaligen Verwendung für die venöse
sang veineux humain (ISO 6710:2017) Blutentnahme (ISO 6710:2017)
This European Standard was approved by CEN on 23 August 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6710:2017 E
worldwide for CEN national Members.

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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 5
2

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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)

European foreword
This document (EN ISO 6710:2017) has been prepared by Technical Committee ISO/TC 76
“Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use” in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 218, and conflicting national standards shall be
withdrawn at the latest by September 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
This document supersedes EN 14820:2004, of which the following has been changed:
— Clause "Introduction" has been updated;
— Clause "Scope" has been updated and phrased clearer. Blood culture bottles have been excluded
from this standard, as it does not address the special needs for this kind of testing;
— Clause "Normative references" has been updated;
— Clause 'Terms and definitions" has been updated and extended;
— Clause "Materials" has been updated;
— Clause "Nominal liquid capacity" has been shortened and renamed to "Draw vol
...