Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

This document specifies requirements for check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus.
NOTE   The functional requirements in this document also apply to built-in check valves.

Infusionsgeräte zur medizinischen Verwendung - Teil 12: Rückschlagventile zur einmaligen Verwendung (ISO 8536-12:2021)

Dieses Dokument legt Anforderungen für Rückschlagventile fest, die zur einmaligen Verwendung bestimmt sind und sowohl mit Infusionsgeräten für die Schwerkraftinfusion als auch mit Druckinfusionsapparaten verwendet werden.
ANMERKUNG   Die funktionalen Anforderungen in diesem Dokument gelten auch für Inline-Rückschlagventile.

Matériel de perfusion à usage médical - Partie 12: Clapet antiretour non réutilisables (ISO 8536-12:2021)

Infuzijska oprema za uporabo v medicini - 12. del: Kontrolni ventili za enkratno uporabo (ISO 8536-12:2021)

General Information

Status
Published
Public Enquiry End Date
19-Mar-2020
Publication Date
15-Apr-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Mar-2021
Due Date
16-May-2021
Completion Date
16-Apr-2021

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SLOVENSKI STANDARD
SIST EN ISO 8536-12:2021
01-maj-2021
Infuzijska oprema za uporabo v medicini - 12. del: Kontrolni ventili za enkratno
uporabo (ISO 8536-12:2021)

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-

12:2021)
Infusionsgeräte zur medizinischen Verwendung - Teil 12: Rückschlagventile zur
einmaligen Verwendung (ISO 8536-12:2021)

Matériel de perfusion à usage médical - Partie 12: Clapet antiretour non réutilisables

(ISO 8536-12:2021)
Ta slovenski standard je istoveten z: EN ISO 8536-12:2021
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-12:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-12:2021
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SIST EN ISO 8536-12:2021
EN ISO 8536-12
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 12: Check valves
for single use (ISO 8536-12:2021)

Matériel de perfusion à usage médical - Partie 12: Infusionsgeräte zur medizinischen Verwendung - Teil

Clapet antiretour à usage unique (ISO 8536-12:2021) 12: Rückschlagventile zur einmaligen Verwendung

(ISO 8536-12:2021)
This European Standard was approved by CEN on 25 January 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, 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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-12:2021 E

worldwide for CEN national Members.
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SIST EN ISO 8536-12:2021
EN ISO 8536-12:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 8536-12:2021
EN ISO 8536-12:2021 (E)
European foreword

This document (EN ISO 8536-12:2021) 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 2021, and conflicting national standards shall

be withdrawn at the latest by August 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.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 8536-12:2021 has been approved by CEN as EN ISO 8536-12:2021 without any

modification.
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SIST EN ISO 8536-12:2021
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SIST EN ISO 8536-12:2021
INTERNATIONAL ISO
STANDARD 8536-12
Second edition
2021-02
Infusion equipment for medical use —
Part 12:
Check valves for single use
Matériel de perfusion à usage médical —
Partie 12: Clapets antiretour à usage unique
Reference number
ISO 8536-12:2021(E)
ISO 2021
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SIST EN ISO 8536-12:2021
ISO 8536-12:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 8536-12:2021
ISO 8536-12:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Designation ................................................................................................................................................................................................................ 2

5 Materials ....................................................................................................................................................................................................................... 2

6 Physical requirements .................................................................................................................................................................................... 2

6.1 Particulate contamination ............................................................................................................................................................. 2

6.2 Leakage .......................................................................................................................................................................................................... 2

6.3 ISO 80369 (all parts) compatibility ...................................................................................................................................... 2

6.4 Counterflow pressure resistance ............................................................................................................................................ 2

6.5 Flow rate ....................................................................................................................................................................................................... 3

6.6 Blocking performance....................................................................................................................................................................... 3

6.7 Opening pressure .................................................................................................................................................................................. 3

6.8 Protective caps ........................................................................................................................................................................................ 3

7 Chemical requirements ................................................................................................................................................................................. 3

8 Biological requirements ............................................................................................................................................................................... 3

8.1 General ........................................................................................................................................................................................................... 3

8.2 Sterility .......................................................................................................................................................................................................... 3

8.3 Pyrogenicity ............................................................................................................................................................................................... 3

9 Labelling ........................................................................................................................................................................................................................ 3

9.1 General ........................................................................................................................................................................................................... 3

9.2 Label on unit container .................................................................................................................................................................... 4

9.3 Label on shelf or multi-unit container ................................................................................................................................ 4

10 Packaging ..................................................................................................................................................................................................................... 4

11 Disposal .......................................................................................................................................................................................................................... 4

Annex A (normative) Physical tests ....................................................................................................................................................................... 5

Bibliography .............................................................................................................................................................................................................................11

© ISO 2021 – All rights reserved iii
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SIST EN ISO 8536-12:2021
ISO 8536-12:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection,

and blood processing equipment for medical and pharmaceutical use, in collaboration with the European

Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in

accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 8536-12:2007), which has been

technically revised. It also incorporates the Amendment ISO 8536-12:2007/Amd.1:2012.

The main changes compared to the previous edition are as follows:
— the title of this document has been amended by "for single use";
— Clause 3 has been completely reviewed;
— Clause 4, 'Designation' refers now to 'Labelling';
— the requirement on tensile strength has been deleted;
— the connecting requirements have been aligned to the ISO 80369 series;
— Clause 11 has been added;

— Annex A has been completely updated and aligned with the physical requirements given in Clause 6;

— the normative references have been updated;
— a bibliography has been added;
— complete editorial review.
A list of all parts in the ISO 8536 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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SIST EN ISO 8536-12:2021
INTERNATIONAL STANDARD ISO 8536-12:202
...

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