SIST EN ISO 8536-3:2009
(Main)Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)
ISO 8536-3:2009 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.
Infusionsgeräte zur medizinischen Verwendung - Teil 3: Aluminium-Bördelkappen für Infusionsflaschen (ISO 8536-3:2009)
Dieser Teil von ISO 8536 legt Aluminium-Bördelkappen für Infusionsflaschen aus Glas nach ISO 8536-1 fest.
Matériel de perfusion à usage médical - Partie 3: Capsules en aluminium pour flacons de perfusion (ISO 8536-3:2009)
L'ISO 8536-3:2009 spécifie des capsules en aluminium pour flacons de perfusion en verre, conformément à l'ISO 8536-1.
Infuzijska oprema za uporabo v medicini - 3. del: Aluminijeve zaporke za infuzijske steklenice (ISO 8536-3:2009)
General Information
Relations
Overview
EN ISO 8536-3:2009 - "Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles" specifies the design, dimensions, tolerances and performance requirements for aluminium caps used with infusion glass bottles that comply with ISO 8536-1. This CEN-endorsed international standard covers one-, two- and three-piece tear-off caps, their designation, packaging and marking, and references test and tolerance standards applicable to medical infusion closures.
Key topics and requirements
- Scope: Aluminium caps for infusion glass bottles (used with infusion equipment for medical use) in accordance with ISO 8536-1. The standard clarifies that aluminium caps are not primary packaging in direct contact with the infusion solution.
- Types and construction:
- Type A: aluminium cap with centre hole
- Type C: aluminium cap with three-bridge tab
- Type F: protective aluminium cap with complete tear-off tab
- Disc E: protective disc (used in three-piece caps)
- Caps can be one-, two- or three-piece assemblies; component combinations and bridge widths depend on intended resistance.
- Dimensions and tolerances:
- Detailed cap dimensions are given in figures and Table 1 of the standard.
- Tolerances follow ISO 2768‑1 (linear/angular) and ISO 2768‑2 (geometrical).
- Mechanical performance:
- Force requirements to remove tear-off tabs or break bridges are specified (see Table 2). Example ranges: for nominal size 28 the tab removal and bridge-break forces are defined; larger nominal sizes have correspondingly different ranges.
- Minimum push-in force criteria apply for some multi-piece assemblies (e.g., minimum 5 N to push type A into type F in a three-piece cap).
- Marking and packaging:
- Marking and packaging requirements reference ISO 8872, and designation format is defined (example: "Cap ISO 8536-3 - A2 - 32").
Applications and users
- Manufacturers of aluminium closures and infusion bottle assemblies use EN ISO 8536-3:2009 to design caps that meet international dimensional and performance requirements.
- Medical device and pharmaceutical packaging engineers rely on this standard to ensure compatibility with infusion glass bottles and maintain regulatory conformance.
- Quality control and testing laboratories apply the standard’s test methods and force criteria to verify production batches.
- Procurement, regulatory and compliance teams reference the standard when specifying components for hospitals, infusion systems and sterile filling lines.
Related standards
- ISO 8536-1 (Infusion glass bottles)
- ISO 8872 (Aluminium caps - general requirements and test methods)
- ISO 2768-1 / ISO 2768-2 (General tolerances)
- Other parts of ISO 8536 series (Parts 2, 4–12) covering closures, infusion sets and accessories
Keywords: EN ISO 8536-3:2009, aluminium caps, infusion bottles, infusion equipment, medical closures, tear-off cap, dimensions and tolerances, ISO 8536.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
1DGRPHãþD
SIST EN ISO 8536-3:2000
SIST EN ISO 8536-3:2000/AC:2000
Infuzijska oprema za uporabo v medicini - 3. del: Aluminijeve zaporke za infuzijske
steklenice (ISO 8536-3:2009)
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO
8536-3:2009)
Infusionsgeräte zur medizinischen Verwendung - Teil 3: Aluminium-Bördelkappen für
Infusionsflaschen (ISO 8536-3:2009)
Matériel de perfusion à usage médical - Partie 3: Capsules en aluminium pour flacons de
perfusion (ISO 8536-3:2009)
Ta slovenski standard je istoveten z: EN ISO 8536-3:2009
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.
EUROPEAN STANDARD
EN ISO 8536-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.040.20 Supersedes EN ISO 8536-3:1999
English Version
Infusion equipment for medical use - Part 3: Aluminium caps for
infusion bottles (ISO 8536-3:2009)
Matériel de perfusion à usage médical - Partie 3: Capsules Infusionsgeräte zur medizinischen Verwendung - Teil 3:
en aluminium pour flacons de perfusion (ISO 8536-3:2009) Aluminium-Bördelkappen für Infusionsflaschen (ISO 8536-
3:2009)
This European Standard was approved by CEN on 16 May 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-3:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 8536-3:2009) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use" in collaboration with CEN
Sub-sector S02 “Transfusion equipment”, the secretariat of which is held by CMC.
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 December 2009, and conflicting national standards shall be withdrawn
at the latest by December 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8536-3:1999.
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 8536-3:2009 has been approved by CEN as a EN ISO 8536-3:2009 without any modification.
INTERNATIONAL ISO
STANDARD 8536-3
Third edition
2009-06-01
Infusion equipment for medical use —
Part 3:
Aluminium caps for infusion bottles
Matériel de perfusion à usage médical —
Partie 3: Capsules en aluminium pour flacons de perfusion
Reference number
ISO 8536-3:2009(E)
©
ISO 2009
ISO 8536-3:2009(E)
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ii © ISO 2009 – All rights reserved
ISO 8536-3:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
...
Frequently Asked Questions
SIST EN ISO 8536-3:2009 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)". This standard covers: ISO 8536-3:2009 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.
ISO 8536-3:2009 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.
SIST EN ISO 8536-3:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 8536-3:2009 has the following relationships with other standards: It is inter standard links to SIST EN ISO 8536-3:2000/AC:2000, SIST EN ISO 8536-3:2000, SIST EN ISO 8536-3:2009/A1:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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