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)

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 - Teil15: 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
• Public Enquiry End Date: 20-Nov-2022
• Publication Date: 12-Apr-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Apr-2023
• Due Date: 11-Jun-2023
• Completion Date: 13-Apr-2023
• Ref Project: 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: SIST 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: 01-May-2023

Overview

SIST EN ISO 8536-15:2022/A1:2023 is an important international standard governing infusion equipment for medical use, specifically focusing on light-protective infusion sets for single use. Issued as Amendment 1 to ISO 8536-15:2022, this standard, developed by ISO/TC 76 in collaboration with CEN/TC 205, sets essential requirements for the design, materials, and performance of infusion sets that incorporate light-protective agents within the fluid path. This ensures the safe administration of photosensitive pharmaceutical solutions by preventing degradation caused by light exposure.

The standard aligns with global best practices and harmonizes requirements across many European nations, thereby facilitating consistent manufacturing quality and regulatory compliance. It addresses both technical specifications and biological safety, reinforcing patient safety during intravenous infusions.

Key Topics

• Scope and Purpose
  SIST EN ISO 8536-15:2022/A1:2023 defines the parameters for infusion sets that are single-use and equipped with materials designed to block or reduce light exposure within the fluid path. This is critical for protecting photosensitive medications.

• Material and Performance Specifications
  The standard provides detailed guidelines on the composition of light-protective agents and their integration into medical-grade polymers used in infusion sets. This includes new recommendations on inner surface stability, mandating that no decolourization occurs, ensuring the integrity of the infusion solution.

• Biological Safety and Risk Management
  Incorporation of references to ISO 10993-17 and ISO 10993-18 strengthens the biological evaluation framework for material safety. Manufacturers must conduct chemical characterization and assess leachable substances to comply with allowable limits, reducing patient risk.

• Testing Methods
  The amendment introduces precise testing methods such as Annex C for decolourization assessment and chemical analysis aligned with the ISO biological evaluation framework, promoting reliable quality control.

• Regulatory Impact
  This amendment mandates national standards bodies across Europe to adopt or endorse the updated text by September 2023, ensuring widespread regulatory harmonization within healthcare markets.

Applications

SIST EN ISO 8536-15:2022/A1:2023 is essential for organizations involved in the design, production, and quality assurance of single-use light-protective infusion sets. Its practical applications include:

• Medical Device Manufacturers
  Utilizing the standard ensures products meet stringent safety and performance criteria, enabling market access in regulated regions and enhancing product reliability when handling light-sensitive intravenous drugs.

• Healthcare Providers and Hospitals
  Selection and procurement of infusion sets compliant with this standard guarantee optimized patient care by minimizing risks linked to medication degradation caused by light exposure.

• Regulatory Bodies
  Adoption of the amendment supports harmonized evaluation of infusion equipment safety and efficacy, streamlining approvals and surveillance processes.

• Testing Laboratories
  Providing guidance on standardized testing protocols for material stability and chemical characterization supports compliance verification and certification.

Related Standards

The amendments and references in SIST EN ISO 8536-15:2022/A1:2023 complement several important standards including:

• ISO 10993-17: Biological evaluation of medical devices - Part 17
  Establishes criteria for allowable limits of leachable substances, vital for chemical safety assessment of infusion set materials.

• ISO 10993-18: Biological evaluation of medical devices - Part 18
  Details chemical characterization procedures within risk management frameworks, reinforcing material biocompatibility.

• ISO 8536 Series
  Includes multiple parts addressing different types of infusion equipment, offering a comprehensive structure for infusion device standards.

• United States Pharmacopeia (USP) Chapter 671
  Referenced for chemical testing standards relevant to infusion systems.

By aligning infusion set design and testing with these related standards, manufacturers and healthcare institutions can ensure robust protection for patients receiving light-sensitive intravenous therapies.

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This amendment to EN ISO 8536-15 reinforces the critical role of light-protective infusion sets in clinical practice, promoting enhanced patient safety and device reliability through updated materials’ performance criteria, biological evaluations, and rigorous testing requirements. Compliance with this standard is key for manufacturers and health systems striving for excellence in infusion therapy equipment.

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO
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