SIST EN ISO 8536-12:2021

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)

Le présent document spécifie les exigences applicables aux clapets antiretour à usage unique et utilisés avec un matériel de perfusion à alimentation par gravité et avec un appareil de perfusion sous pression.
Les exigences fonctionnelles du présent document s'appliquent également aux clapets antiretour en ligne.

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
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 11-Mar-2021
• Due Date: 16-May-2021
• Completion Date: 16-Apr-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 8536-12:2021 - Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

Standards Content (Sample)

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

2

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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.

3

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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: [phone]
Email: [e-mail]
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 8536-12:2020
01-april-2020
Infuzijska oprema za uporabo v medicini - 12. del: Kontrolni ventili za enkratno
uporabo (ISO/DIS 8536-12:2020)
Infusion equipment for medical use - Part 12: Check valves for single use (ISO/DIS 8536
-12:2020)
Infusionsgeräte zur medizinischen Verwendung - Teil 12: Rückschlagventile zur
einmaligen Verwendung (ISO/DIS 8536-12:2020)
Matériel de perfusion à usage médical - Partie 12: Clapet antiretour non réutilisables
(ISO/DIS 8536-12:2020)
Ta slovenski standard je istoveten z: prEN ISO 8536-12
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-12:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 8536-12:2020

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oSIST prEN ISO 8536-12:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8536-12
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-02-06 2020-04-30
Infusion equipment for medical use —
Part 12:
Check valves for single use
Matériel de perfusion à usage médical —
Partie 12: Clapet antiretour non réutilisables
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8536-12:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020

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oSIST prEN ISO 8536-12:2020
ISO/DIS 8536-12:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-12:2020
ISO/DIS 8536-12:2020(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 compatibility . 2
6.4 Counterflow pressure resistance . 3
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 . 4
9.1 General . 4
9.2 Label on unit container . 4
9.3 Label on shelf or multi-unit container . 4
10 Packaging . 5
11 Disposal . 5
Annex A (normative) Physical tests . 6
© ISO 2020 – All rights reserved iii

---------------------- Page: 5 ----------------------
oSIST prEN ISO 8536-12:2020
ISO/DIS 8536-12:2020(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 on 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.
This second edition cancels and replaces the first edition (ISO 8536-12:2007), which has been
technically revised. It also incorporates Amendment ISO 8536-12:2007/Amd.1:2012.
The main changes compared to the previous edition are as follows:
— the title of this document standard has been amended by "for single use";
— the Clause 'Terms and definitions' has been completely reviewed;
— the Clause 'Designation' refers now to Clause 'Labelling';
— the requirement on tensile strength has been deleted;
— the connecting requirements have been aligned to the ISO 80369 series;
— a new Clause 'Disposal' has been added;
— the Annex A 'Physical tests' has been completely updated and aligned with the physical requirements
given in Clause 6;
— the 'Normative references' and the 'Bibliography' have been updated;
— 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 2020 – All rights reserved

---------------------- Page: 6 ----------------------
oSIST prEN ISO 8536-12:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 8536-12:2020(E)
Infusion equipment for medical use —
Part 12:
Check valves for single use
1 Scope
This document specifies requirements for check valves intended for single use and used with infusion
equipment both with gravity-feed infusion and with pressure infusion apparatus.
NOTE The functional requirements in this document also apply to inline check valves.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8536-8, Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion
apparatus
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2:
Identification and characterization
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, lab
...