EN ISO 8536-15:2022/A1:2023

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)

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.

Infusionsgeräte zur medizinischen Verwendung - Teil 15: Lichtbeständige Infusionsgeräte zur einmaligen Verwendung - Änderung 1 (ISO 8536-15:2022/Amd 1:2023)

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 -— Amendement 1 (ISO 8536-15:2022/Amd 1:2023)

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 - Dopolnilo A1 (ISO 8536-15:2022/Amd 1:2023)

General Information

• Status: Published
• Publication Date: 14-Mar-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Mar-2023
• Completion Date: 15-Mar-2023
• Ref Project: SIST EN ISO 8536-15:2022/A1:2023 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)

Relations

• Amends: EN ISO 8536-15:2022 - Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)
• Effective Date: 25-May-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-15:2022/A1:2023
01-maj-2023
Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski seti za enkratno
uporabo, zaščiteni pred svetlobo - Dopolnilo A1 (ISO 8536-15:2022/Amd 1:2023)
Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use
- Amendment 1 (ISO 8536-15:2022/Amd 1:2023)
Infusionsgeräte zur medizinischen Verwendung - Teil15: Lichtbeständige Infusionsgeräte
zur einmaligen Verwendung - Änderung 1 (ISO 8536-15:2022/Amd 1:2023)
Matériel de perfusion à usage médical - Partie 15: Perfuseurs photoprotecteurs à usage
unique - Amendement 1 (ISO 8536-15:2022/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 8536-15:2022/A1:2023
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-15:2022/A1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-15:2022/A1:2023

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SIST EN ISO 8536-15:2022/A1:2023


EN ISO 8536-15:2022/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2023
EUROPÄISCHE NORM
ICS 11.040.20
English Version

Infusion equipment for medical use - Part 15: Light-
protective infusion sets for single use - Amendment 1 (ISO
8536-15:2022/Amd 1:2023)
Matériel de perfusion à usage médical -¿ Partie 15: Infusionsgeräte zur medizinischen Verwendung -
Perfuseurs photoprotecteurs à usage unique -¿ Teil15: Lichtbeständige Infusionsgeräte zur einmaligen
Amendement 1 (ISO 8536-15:2022/Amd 1:2023) Verwendung - Änderung 1 (ISO 8536-15:2022/Amd
1:2023)
This amendment A1 modifies the European Standard EN ISO 8536-15:2022; it was approved by CEN on 30 January 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-15:2022/A1:2023 E
worldwide for CEN national Members.

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SIST EN ISO 8536-15:2022/A1:2023
EN ISO 8536-15:2022/A1:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 8536-15:2022/A1:2023
EN ISO 8536-15:2022/A1:2023 (E)
European foreword
This document (EN ISO 8536-15:2022/A1:2023) 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 2023, and conflicting national standards
shall be withdrawn at the latest by September 2023.
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,
...