Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)

This part of ISO 8536 specifies the requirements for infusion sets that use light-protective agents in the fluid path materials (abbreviated as "light-protective infusion sets” henceforth).
This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

Infusionsgeräte zur medizinischen Verwendung - Teil 15: Lichtbeständige Infusionsgeräte zur einmaligen Verwendung (ISO 8536-15:2022)

Dieses Dokument legt die Anforderungen an Infusionssets zum Einmalgebrauch fest, bei denen Lichtschutzmittel in den Materialien der Flüssigkeitsbahn verwendet werden (im Folgenden mit „Lichtschutz Infusionssets“ abgekürzt).
Dieses Dokument enthält außerdem einen Leitfaden für Leistungs  und Qualitätsspezifikationen von Materialien, die in Lichtschutz Infusionssets verwendet werden.

Matériel de perfusion à usage médical - Partie 15: Perfuseurs photoprotecteurs à usage unique (ISO 8536-15:2022)

Le présent document fixe les exigences relatives aux perfuseurs à usage unique qui utilisent des agents photoprotecteurs dans les matériaux du passage du fluide (ci-après dénommés «perfuseurs photoprotecteurs »).
Le présent document fournit également des lignes directrices afférentes aux spécifications de performance et de qualité des matériaux utilisés dans les perfuseurs photoprotecteurs.

Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski seti za enkratno uporabo, zaščiteni pred svetlobo (ISO 8536-15:2022)

General Information

Status
Published
Public Enquiry End Date
24-Apr-2021
Publication Date
11-May-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-Apr-2022
Due Date
30-Jun-2022
Completion Date
12-May-2022

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SLOVENSKI STANDARD
SIST EN ISO 8536-15:2022
01-junij-2022
Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski seti za enkratno
uporabo, zaščiteni pred svetlobo (ISO 8536-15:2022)

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use

(ISO 8536-15:2022)
Infusionsgeräte zur medizinischen Verwendung - Teil 15: Lichtbeständige
Infusionsgeräte zur einmaligen Verwendung (ISO 8536-15:2022)

Matériel de perfusion à usage médical - Partie 15: Perfuseurs photoprotecteurs à usage

unique (ISO 8536-15:2022)
Ta slovenski standard je istoveten z: EN ISO 8536-15:2022
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-15:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 8536-15:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 8536-15:2022
EN ISO 8536-15
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 15: Light-
protective infusion sets for single use (ISO 8536-15:2022)

Matériel de perfusion à usage médical - Partie 15: Infusionsgeräte zur medizinischen Verwendung - Teil

Perfuseurs photoprotecteurs à usage unique (ISO 15: Lichtbeständige Infusionsgeräte zur einmaligen

8536-15:2022) Verwendung (ISO 8536-15:2022)
This European Standard was approved by CEN on 21 February 2022.

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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-15:2022 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 8536-15:2022
EN ISO 8536-15:2022 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 8536-15:2022
EN ISO 8536-15:2022 (E)
European foreword

This document (EN ISO 8536-15:2022) 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 September 2022, and conflicting national standards

shall be withdrawn at the latest by September 2022.

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.

Any feedback and questions on this document should be directed to the users’ national standards

body/national committee. A complete listing of these bodies can be found on the CEN website.

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 8536-15:2022 has been approved by CEN as EN ISO 8536-15:2022 without any

modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 8536-15:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 8536-15:2022
INTERNATIONAL ISO
STANDARD 8536-15
First edition
2022-03
Infusion equipment for medical use —
Part 15:
Light-protective infusion sets for
single use
Matériel de perfusion à usage médical —
Partie 15: Perfuseurs photoprotecteurs à usage unique
Reference number
ISO 8536-15:2022(E)
© ISO 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 8536-15:2022
ISO 8536-15:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 8536-15:2022
ISO 8536-15:2022(E)
Contents Page

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

Introduction .................................................................................................................................................................................................................................v

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

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

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

4 General requirements .................................................................................................................................................................................... 1

5 Materials ....................................................................................................................................................................................................................... 1

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

6.1 General ........................................................................................................................................................................................................... 2

6.2 Transparency ........................................................................................................................................................................................... 2

6.3 Light-protective performance ......... .................................................................................................................................. ........ 2

6.4 Decolourization ...................................................................................................................................................................................... 2

7 Chemical requirements ................................................................................................................................................................................ 2

8 Biological requirements .............................................................................................................................................................................. 2

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

10 Packaging..................................................................................................................................................................................................................... 3

11 Disposal ......................................................................................................................................................................................................................... 3

Annex A (normative) Determination of light transmittance ..................................................................................................... 4

Annex B (normative) Decolourization test – physical method ................................................................................................ 6

Annex C (normative) Chemical method for decolourization test – visual colorimetry .................................7

Bibliography ................................................................................................................................................................................................................................ 8

iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 8536-15:2022
ISO 8536-15:2022(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 collabo
...

SLOVENSKI STANDARD
oSIST prEN ISO 8536-15:2021
01-april-2021
Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski seti za enkratno
uporabo, zaščiteni pred svetlobo (ISO/DIS 8536-15:2021)

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use

(ISO/DIS 8536-15:2021)
Infusionsgeräte zur medizinischen Verwendung - Teil 15: Lichtbeständige
Infusionsgeräte zur einmaligen Verwendung (ISO/DIS 8536-15:2021)

Matériel de perfusion à usage médical - Partie 15: Perfuseurs photoprotecteurs à usage

unique (ISO/DIS 8536-15:2021)
Ta slovenski standard je istoveten z: prEN ISO 8536-15
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-15:2021 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-15:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 8536-15:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8536-15
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-02-22 2021-05-17
Infusion equipment for medical use —
Part 15:
Light-protective infusion sets for single use
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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 8536-15:2021(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 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 8536-15:2021
ISO/DIS 8536-15:2021(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
---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-15:2021
ISO/DIS 8536-15:2021(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 General requirements ..................................................................................................................................................................................... 1

5 Materials ....................................................................................................................................................................................................................... 1

6 Physical requirements .................................................................................................................................................................................... 1

6.1 General ........................................................................................................................................................................................................... 1

6.2 Transparency ............................................................................................................................................................................................ 2

6.3 Light-protective performance .................................................................................................................................................... 2

6.4 Decolourization ...................................................................................................................................................................................... 2

7 Chemical requirements ................................................................................................................................................................................. 2

8 Biological requirements ............................................................................................................................................................................... 2

9 Labelling ........................................................................................................................................................................................................................ 2

10 Packaging ..................................................................................................................................................................................................................... 3

Annex A (normative) Determination of light transmittance ....................................................................................................... 4

Annex B (normative) Decolourization test – physical method .................................................................................................. 6

Annex C (normative) Chemical method for decolourization test - visual colorimetry ....................................7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 8536-15:2021
ISO/DIS 8536-15:2021(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.
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
---------------------- Page: 6 ----------------------
oSIST prEN ISO 8536-15:2021
ISO/DIS 8536-15:2021(E)
Introduction

With the continuous development of infusion technology and the increasingly exacting clinical

requirements, some infusion sets adapted to specific clinical requirements have been produced in

succession.

Some pharmaceuticals are light sensitive and need to be infused under light-protective conditions

clinically, such as sodium nitroprusside, nitroglycerin and vitamin B2. Ordinary infusion sets

conforming to other applicable parts of ISO 8536 cannot meet this infusion requirement, therefore, it is

necessary to use the light-protective infusion set as specified in this part of ISO 8536.

This document stipulates the light-transmission requirements for the drip chamber and the tube. Since

other components are limited by their external dimensions, they are not subject to light-transmission

requirements and whether they will be light-protective or not is at the manufacturer’s discretion.

It is the responsibility of the device manufacturer to keep the light-protective infusion sets stable

during the shelf life without decolourization. Annex B and Annex C of the standard give the methods for

decolourization evaluation of light-protective infusion sets. The alternative solve

...

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