EN ISO 1135-3:2017
(Main)Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
ISO 1135-3:2016 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
ISO 1135-3:2016 also aims to provide
a) specifications relating to the quality and performance of materials used in transfusion equipment, and
b) a unified presentation of terms for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.
Transfusionsgeräte zur medizinischen Verwendung - Teil 3: Blutentnahmegeräte zur einmaligen Verwendung (ISO 1135-3:2016)
Dieser Teil von ISO 1135 legt Anforderungen an Blutentnahmegeräte für die medizinische Verwendung fest, um die funktionelle Austauschbarkeit von Transfusionsgeräten sicherzustellen. Sie ist auf sterilisierte Blutentnahmegeräte zur einmaligen Verwendung anzuwenden.
Dieser Teil von ISO 1135 stellt auch zur Verfügung:
a) Qualitätsanforderungen für die in Blutentnahmegeräten verwendeten Werkstoffe, und
b) eine einheitliche Darstellung von Benennungen für Blutentnahmegeräte
festzulegen.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 1135.
Matériel de transfusion à usage médical - Partie 3: Appareils non réutilisables pour prélèvement sanguin (ISO 1135-3:2016)
ISO 1135-3:2016 fixe les spécifications des divers types d'appareils pour prélèvement sanguin à usage médical afin d'assurer I'interchangeabilité fonctionnelle du matériel de transfusion. Elle s'applique aux appareils stériles non réutilisables pour prélèvement sanguin.
ISO 1135-3:2016 a également pour but de fournir
a) des spécifications relatives à la qualité et aux performances des matériaux utilisés pour le matériel de transfusion; et
b) une terminologie uniforme concernant ce type de matériel.
Dans certains pays, la pharmacopée nationale ou d'autres règlements nationaux sont juridiquement contraignants et prévalent sur les dispositions de l'ISO 1135-3:2016.
Transfuzijska oprema za uporabo v medicini - 3. del: Seti za odvzem krvi za enkratno uporabo (ISO 1135-3:2016)
Ta del standarda EN ISO 1135 določa zahteve za vrste setov za odvzem krvi za uporabo v medicini, da se zagotovi funkcijska zamenljivost opreme za transfuzijo. Uporablja se samo za sterilizirane sete za odvzem krvi za enkratno uporabo. Materiali in sestavni deli setov so validirani na podlagi različnih preskusnih metod. Proizvajalec izbere ustrezne preskusne metode za uskladitev z zahtevami, določenimi v tem delu standarda EN ISO 1135. Druga cilja tega dela standarda EN ISO 1135 sta zagotoviti a) specifikacije glede kakovosti in učinkovitosti materialov, ki se uporabljajo v opremi za transfuzijo; b) enotno predstavitev pogojev in označb za takšno opremo. V nekaterih državah so nacionalne farmakopeje ali drugi nacionalni predpisi pravno zavezujoči in imajo prednost pred tem delom standarda EN ISO 1135.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 1135-3:2017
01-maj-2017
Transfuzijska oprema za uporabo v medicini - 3. del: Seti za odvzem krvi za
enkratno uporabo (ISO 1135-3:2016)
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO
1135-3:2016)
Transfusionsgeräte zur medizinischen Verwendung - Teil 3: Blutentnahmegeräte zur
einmaligen Verwendung (ISO 1135-3:2016)
Matériel de transfusion à usage médical - Partie 3: Appareils non réutilisables pour
prélèvement de sang (ISO 1135-3:2016)
Ta slovenski standard je istoveten z: EN ISO 1135-3:2017
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 1135-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 1135-3:2017
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SIST EN ISO 1135-3:2017
EN ISO 1135-3
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Transfusion equipment for medical use - Part 3: Blood-
taking sets for single use (ISO 1135-3:2016)
Matériel de transfusion à usage médical - Partie 3: Transfusionsgeräte zur medizinischen Verwendung -
Appareils non réutilisables pour prélèvement sanguin Teil 3: Blutentnahmegeräte zur einmaligen
(ISO 1135-3:2016) Verwendung (ISO 1135-3:2016)
This European Standard was approved by CEN on 24 August 2016.
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 1135-3:2017 E
worldwide for CEN national Members.
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
Contents
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered. 5
2
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
European foreword
This document (EN ISO 1135-3:2017) 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 205 “Non-active 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 August 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] 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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, I
...
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