ISO 8536-15:2022

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

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

Matériel de perfusion à usage médical — Partie 15: Perfuseurs photoprotecteurs à usage unique

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.

General Information

• Status: Published
• Publication Date: 07-Mar-2022
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
• Current Stage: 6060 - International Standard published
• Start Date: 08-Mar-2022
• Due Date: 15-Apr-2022
• Completion Date: 08-Mar-2022

Relations

• Consolidates: ISO 16075-2:2020 - Guidelines for treated wastewater use for irrigation projects — Part 2: Development of the project
• Effective Date: 06-Jun-2022
• Amended By: ISO 8536-15:2022/Amd 1:2023 - Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1
• Effective Date: 06-Jun-2022

Standards Content (Sample)

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: 1 ----------------------
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
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: 3 ----------------------
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 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).

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.
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 8536-15:2022(E)
Introduction

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

requirements, some infusion sets need to be adapted to specific clinical requirements.

Some pharmaceuticals, such as sodium nitroprusside, nitroglycerin and vitamin B2, are light sensitive

and need to be clinically infused under light-protective conditions; this document is applicable to such

sets.

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-protection of the infusion sets stable

during the shelf life. Annex A, Annex B and Annex C give the methods for evaluation of light-protective

infusion sets.
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 8536-15:2022(E)
Infusion equipment for medical use —
Part 15:
Light-protective infusion sets for single use
1 Scope

This document specifies the requirements for infusion sets for single use that use light-protective

agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).

This document also provides guidelines for performance and quality specifications of materials used in

light-protective infusion sets.
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.

GB/T 601-2016, Chemical reagent — Preparations of reference titration solutions
ISO 8536 (all parts), Infusion equipment fo
...

NORME ISO
INTERNATIONALE 8536-15
Première édition
2022-03
Matériel de perfusion à usage
médical —
Partie 15:
Perfuseurs photoprotecteurs à usage
unique
Infusion equipment for medical use —
Part 15: Light-protective infusion sets for single use
Numéro de référence
ISO 8536-15:2022(F)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 8536-15:2022(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse
© ISO 2022 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 8536-15:2022(F)
Sommaire Page

Avant-propos .............................................................................................................................................................................................................................iv

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

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ..................................................................................................................................................................................1

3 Termes et définitions ...................................................................................................................................................................................... 1

4 Exigences générales ........................................................................................................................................... ...............................................1

5 Matériaux ..................................................................................................................................................................................................................... 2

6 Exigences physiques ......................................................................................................................................................................................... 2

6.1 Généralités ................................................................................................................................................................................................. 2

6.2 Transparence ........................................................................................................................................................................................... 2

6.3 Performance de photoprotection ........................................................................................................................................... 2

6.4 Décoloration ...................................................................... ........................................................................................................................ 2

7 Exigences chimiques ........................................................................................................................................................................................3

8 Exigences biologiques..................................................................................................................................................................................... 3

9 Etiquetage ................................................................................................................................................................................................................... 3

10 Emballage .................................................................................................................................................................................................................... 3

11 Mise au rebut ............................................................................................................................................................................................................ 3

Annexe A (normative) Détermination de la transmission de lumière ............................................................................ 4

Annexe B (normative) Essai de décoloration – Méthode physique ...................................................................................... 6

Annexe C (normative) Méthode d'essai chimique pour la détermination de la décoloration

– Colorimétrie par détection visuelle ............................................................................................................................................7

Bibliographie .............................................................................................................................................................................................................................. 8

iii
© ISO 2022 – Tous droits réservés
---------------------- Page: 3 ----------------------
ISO 8536-15:2022(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a

été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir

www.iso.org/directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www.iso.org/brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www.iso.org/avant-propos.

Le présent document a été élaboré par le comité technique ISO/TC 76, Appareils de transfusion, de

perfusion et d'injection et appareils destinés au traitement du sang à usage médical et pharmaceutique, en

collaboration avec le comité technique CEN/TC 205, Dispositifs médicaux non-actifs, du Comité européen

de normalisation (CEN) conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord

de Vienne).

Une liste de toutes les parties de la série ISO 8536 se trouve sur le site web de l’ISO.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www.iso.org/fr/members.html.
© ISO 2022 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO 8536-15:2022(F)
Introduction

Avec l’évolution continue des techniques de perfusion et des exigences cliniques de plus en plus

assujettissantes, un certain nombre de perfuseurs ont besoin d'être adaptés à des exigences cliniques

spécifiques.

Certains médicaments comme le sodium nitroprusside, la nitroglycérine et la vitamine B2, sont

photosensibles et il est indispensable de pratiquer les perfusions dans les conditions cliniques à l’abri

de la lumière. C'est à ce type de perfuseurs que le présent document est applicable.

Le présent document stipule les exigences relatives à la translucidité de la chambre compte-gouttes et

du tube. Étant donné que les autres composants sont de dimensions externes restreintes, ils ne sont pas

soumis aux exigences de translucidité. La décision de les rendre photoprotecteurs, ou non, est laissée à

la discrétion du fabricant.

Le maintien de la stabilité pendant toute la durée de vie des perfuseurs photoprotecteurs relève de la

responsabilité du fabricant du dispositif. L’Annexe A, l'Annexe B et l’Annexe C fournissent les méthodes

qui permettent d’évaluer les perfuseurs photoprotecteurs.
© ISO 2022 – Tous droits réservés
---------------------- Page: 5 ----------------------
NORME INTERNATIONALE ISO 8536-15:2022(F)
Matériel de perfusion à usage médical —
Partie 15:
Perfuseurs photoprotecteurs à usage unique
1 Domaine d’application

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.

2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s'applique (y compris les

éventuels amendements).
GB/T 601-2016, Chemical reagent — Preparations of reference titration solutions
ISO 8536 (toutes les parties), Matériel de perfusion à usage médical
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions suivants s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp

— IEC Ele
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 8536-15
ISO/TC 76
Infusion equipment for medical use —
Secretariat: DIN
Voting begins on:
Part 15:
2021-11-25
Light-protective infusion sets for
Voting terminates on:
single use
2022-01-20
Matériel de perfusion à usage médical —
Partie 15: Perfuseurs photoprotecteurs à usage unique
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 8536-15:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 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 ................................................................................................................................................................................... 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 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/FDIS 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, 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).

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.
© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 8536-15:2021(E)
Introduction

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

requirements, some infusion sets need to be adapted to specific clinical requirements.

Some pharmaceuticals, such as sodium nitroprusside, nitroglycerin and vitamin B2, are light sensitive

and need to be clinically infused under light-protective conditions; this document is applicable to such

sets.

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-protection of the infusion sets stable

during the shelf life. Annex A, Annex B and Annex C give the methods for evaluation of light-protective

infusion sets.
© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 8536-15:2021(E)
Infusion equipment for medical use —
Part 15:
Light-protective infusion sets for single use
1 Scope

This document specifies the requirements for infusion sets for single use that use light-protective

agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).

This document also provides guidelines for performance and quality specifications of materials used in

light-protective infusion sets.
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
...