Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

Infusionsgeräte zur medizinischen Verwendung - Teil 14: Klemmen und Durchflussregler für Transfusions- und Infusionsgeräte ohne Flüssigkeitskontakt (ISO 8536-14:2016)

Matériel de perfusion à usage médical - Partie 14: Clamps et limiteurs de débit pour appareils de transfusion et de perfusion sans contact à fluide (ISO 8536-14:2016)

ISO 8536-14:2016 spécifie les exigences applicables aux clamps non stériles et aux limiteurs de débit utilisés en tant que sous-composants pour réguler le débit des solutions intraveineuses et/ou des composants sanguins dans les appareils de perfusion et de transfusion sanguine stérilisés et dans les poches de sang sans contact à fluide.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales présentent un caractère obligatoire et peuvent prévaloir sur l'ISO 8536-14:2016.

Infuzijska oprema za uporabo v medicini - 14. del: Sponke in regulatorji pretoka transfuzijskih in infuzijskih naprav brez stika s tekočino (ISO 8536-14:2016)

Ta del standarda ISO 8536 določa zahteve za naprave, ki se uporabljajo za nadzor pretoka intravenoznih raztopin in/ali krvnih sestavin prek kompletov za infuzijo in transfuzijo krvi ter sestavov vrečk za kri brez stika s tekočino. Takšne komponente so lahko sestavni del medicinskega pripomočka ali »samostojne« komponente.

General Information

Status
Published
Publication Date
06-Feb-2018
Withdrawal Date
27-Feb-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
07-Feb-2018
Completion Date
07-Feb-2018

Buy Standard

Standard
EN ISO 8536-14:2018
English language
16 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-14:2018
01-april-2018
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO6SRQNHLQUHJXODWRUMLSUHWRND
WUDQVIX]LMVNLKLQLQIX]LMVNLKQDSUDYEUH]VWLNDVWHNRþLQR ,62
Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion
and infusion equipment without fluid contact (ISO 8536-14:2016)
Infusionsgeräte zur medizinischen Verwendung - Teil 14: Klemmen und Durchflussregler
für Transfusions- und Infusionsgeräte ohne Flüssigkeitskontakt (ISO 8536-14:2016)
Matériel de perfusion à usage médical - Partie 14: Clamps et limiteurs de débit pour
appareils de transfusion et de perfusion sans contact à fluide (ISO 8536-14:2016)
Ta slovenski standard je istoveten z: EN ISO 8536-14:2018
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-14:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8536-14:2018

---------------------- Page: 2 ----------------------

SIST EN ISO 8536-14:2018


EN ISO 8536-14
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2018
EUROPÄISCHE NORM
ICS 11.040.20
English Version

Infusion equipment for medical use - Part 14: Clamps and
flow regulators for transfusion and infusion equipment
without fluid contact (ISO 8536-14:2016)
Matériel de perfusion à usage médical - Partie 14: Infusionsgeräte zur medizinischen Verwendung - Teil
Clamps et limiteurs de débit pour appareils de 14: Klemmen und Durchflussregler für Transfusions-
transfusion et de perfusion sans contact à fluide (ISO und Infusionsgeräte ohne Flüssigkeitskontakt (ISO
8536-14:2016) 8536-14:2016)
This European Standard was approved by CEN on 19 December 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-14:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
Contents Page
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

---------------------- Page: 4 ----------------------

SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
European foreword
This document (EN ISO 8536-14:2018) 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 2018, and conflicting national standards shall
be withdrawn at the latest by February 2021.
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.
Acc
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.