EN ISO 8536-1:2011

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO/FDIS 8536-1:2011)

ISO 8536-1:2011 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.

Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO/FDIS 8536-1:2011)

Dieser Teil von ISO 8536 legt Maße, Ausführungen und Anforderungen für Infusionsflaschen aus Glas fest,
die erforderlich sind, um die funktionelle Austauschbarkeit sicherzustellen. Er gilt nur für Infusionsflaschen zur
einmaligen Verwendung.

Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO/FDIS 8536-1:2011)

L'ISO 8536-1:2011 spécifie les dimensions, la performance et les exigences relatives aux flacons en verre pour perfusion afin d'assurer leur interchangeabilité. L'ISO 8536-1:2011 ne s'applique qu'aux flacons en verre pour perfusion non réutilisables.

Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2011)

Ta del ISO 8536 določa mere, zmogljivost in zahteve za infuzijske steklenice, ki so potrebne za zagotavljanje funkcionalne izmenljivosti. Velja le za infuzijske steklenice za enkratno uporabo

General Information

• Status: Published
• Publication Date: 31-Aug-2011
• Withdrawal Date: 30-Mar-2012
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Sep-2011
• Completion Date: 01-Sep-2011
• Ref Project: SIST EN ISO 8536-1:2011 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)

Relations

• Replaces: EN ISO 8536-1:2008 - Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2006)
• Effective Date: 10-Sep-2011

Overview

EN ISO 8536-1:2011 (CEN adoption of ISO 8536-1:2011) specifies the dimensions, performance and requirements for single‑use infusion glass bottles used as primary packaging for infusion solutions. The standard ensures functional interchangeability between bottles from different manufacturers and sets material, marking and performance criteria to protect patient safety during storage and administration.

Key topics and technical requirements

• Scope: Applies only to single‑use infusion glass bottles (typical nominal capacities 50–1 000 ml).
• Dimensions and models: Defines dimensional requirements and three typical neck finishes (models A, B, C) with common neck diameters (32 mm, 28 mm, 29 mm) and associated dimensional tolerances to ensure interchangeability.
• Materials: Permitted container glass types:
  • Borosilicate glass (colourless/cl or amber/br)
  • Soda‑lime‑silica glass
    Manufacturers must notify users of composition or colour changes in advance.
• Hydrolytic resistance: Internal surface must meet one of the hydrolytic resistance container classes (HC 1, HC 2, HC 3) when tested per ISO 4802‑1 / ISO 4802‑2.
• Mechanical and thermal performance:
  • Internal pressure resistance: bottles must withstand 600 kPa (6 bar) per ISO 7458.
  • Thermal shock resistance: ΔT = 42 °C for soda‑lime‑silica, ΔT = 60 °C for borosilicate, tested per ISO 7459.
• Annealing quality: Residual stress limited so optical retardation ≤ 40 nm per mm of glass thickness (viewed in a strain viewer).
• Marking and designation: Mandatory permanent marks (manufacturer, hydrolytic class, optional ISO logo). Standard designation format example:
  • Infusion bottle ISO 8536-1 – A – 500 – cl – HC 2
• Normative references: Key test standards cited include ISO 719/720, ISO 4802‑1/‑2, ISO 7458, ISO 7459.

Applications and who uses the standard

• Manufacturers of infusion glass bottles and primary packaging - for product design, quality control and conformity.
• Medical device and pharmaceutical engineers - to specify compatible bottles for parenteral solutions.
• Regulatory & procurement teams - to define compliance requirements for tenders and registrations.
• Testing laboratories - to perform hydrolytic, pressure and thermal shock tests per referenced ISO methods.
• Hospitals and clinical supply managers - to ensure device interchangeability and traceability.

Related standards

EN ISO 8536 is a multipart series; relevant companion parts include:

• Part 2: Closures for infusion bottles
• Part 3: Aluminium caps for infusion bottles
• Parts 4–12: Infusion sets, pressure equipment accessories, filters, check valves, etc.

Keywords: EN ISO 8536-1:2011, infusion glass bottles, infusion equipment, single‑use infusion bottles, hydrolytic resistance, borosilicate glass, soda‑lime‑silica, dimensions, internal pressure, thermal shock.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Infuzijska oprema za uporabo v medicini - 1. del: Infuzijske steklenice (ISO 8536-1:2011)Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011)Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011)Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8536-1:2011SIST EN ISO 8536-1:2011en,fr,de01-december-2011SIST EN ISO 8536-1:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 8536-1
September 2011 ICS 11.040.20 Supersedes EN ISO 8536-1:2008English Version
Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)
Matériel de perfusion à usage médical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011)
Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011) This European Standard was approved by CEN on 31 August 2011.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-1:2011: ESIST EN ISO 8536-1:2011

Reference numberISO 8536-1:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO8536-1Fourth edition2011-09-01Infusion equipment for medical use —
Part 1: Infusion glass bottles Matériel de perfusion à usage médical — Partie 1: Flacons en verre pour perfusion
ISO 8536-1:2011(E)
©
ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56  CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
[e-mail] Web
www.iso.org Published in Switzerland
ii © ISO 2011 – All rights reserved
ISO 8536-1:2011(E) © ISO 2011 – All rights reserved iii 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 8536-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. This fourth edition cancels and replaces the third edition (ISO 8536-1:2006), of which it constitutes a minor revision. The principle changes to the third edition are the updating of normative references to ISO 4802-1 and ISO 4802-2, and the addition of a note at the start of Clause 8. ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:  Part 1: Infusion glass bottles  Part 2: Closures for infusion bottles  Part 3: Aluminium caps for infusion bottles  Part 4: Infusion sets for single use, gravity feed  Part 5: Burette infusion sets for single use, gravity feed  Part 6: Freeze drying closures for infusion bottles  Part 7: Caps made of aluminium-plastics combinations for infusion bottles  Part 8: Infusion equipment for use with pressure infusion apparatus  Part 9: Fluid lines for use with pressure infusion equipment  Part 10: Accessories for fluid lines for use with pressure infusion equipment  Part 11: Infusion filters for use with pressure infusion equipment  Part 12: Check valves SIST EN ISO 8536-1:2011

ISO 8536-1:2011(E) iv © ISO 2011 – All rights reserved Introduction Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, it is essential to avoid possible interactions in order to guarantee the patient's safety. Adequate means to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems.
INTERNATIONAL STANDARD ISO 8536-1:2011(E) © ISO 2011 – All rights reserved 1 Infusion equipment for medical use —
Part 1: Infusion glass bottles 1 Scope This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest ed
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