SIST EN ISO 8536-3:2009/A1:2022
(Amendment)Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
Infusionsgeräte zur medizinischen Verwendung - Teil 3: Aluminium-Bördelkappen für Infusionsflaschen - Änderung 1 (ISO 8536-3:2009/Amd 1:2022)
No scope available
Matériel de perfusion à usage médical - Partie 3: Capsules en aluminium pour flacons de perfusion - Amendement 1 (ISO 8536-3:2009/Amd 1:2022)
Infuzijska oprema za uporabo v medicini - 3. del: Aluminijeve zaporke za infuzijske steklenice - Dopolnilo A1 (ISO 8536-3:2009/Amd 1:2022)
General Information
Relations
Overview
SIST EN ISO 8536-3:2009/A1:2022 is an important amendment to the international standard ISO 8536-3:2009, which specifies requirements for aluminium caps used on infusion bottles for medical use. Published by the European Committee for Standardization (CEN) in September 2022, this amendment refines dimensional and mechanical properties ensuring enhanced safety and compatibility in infusion equipment.
This standard forms part of a broader series dedicated to infusion, transfusion, and injection equipment. It has been developed by ISO Technical Committee ISO/TC 76, specializing in medical and pharmaceutical use equipment, in close cooperation with CEN/SS S02. SIST EN ISO 8536-3:2009/A1:2022 is recommended for adoption by all CEN member countries and replaces conflicting national standards by March 2023.
Key Topics
Aluminium Cap Dimensions: The amendment updates dimensional specifications for aluminium caps, including thickness, diameter ranges, and tab designs. These precise measurements (provided in millimeters) ensure consistent fit and reliable sealing on infusion bottles.
Mechanical Performance: It defines minimum and maximum forces required to remove tabs on caps, crucial for usability and safety during medical procedures. For example, the force ranges necessary to break tear-off or bridge tabs are standardized depending on nominal sizes (28 mm, 29 mm, 32 mm).
Compatibility and Safety: By harmonizing the physical and mechanical characteristics of aluminium caps, the standard prevents contamination risks, maintains sterility, and facilitates safe handling of infusion bottles.
International and Multilingual Implementation: The amendment is available in English, French, and German, with translations by CEN members endorsed officially, ensuring wide accessibility across EU and other countries.
Applications
Medical Infusion Systems: SIST EN ISO 8536-3:2009/A1:2022 applies specifically to the aluminium sealing caps used for parenteral infusion bottles, a critical component in intravenous therapy and fluid administration.
Medical Device Manufacturing: Manufacturers of infusion bottles and medical packaging must comply with these updated specifications to guarantee product conformity and market access throughout Europe.
Healthcare Providers: Hospitals, clinics, and healthcare professionals benefit from standardized caps that aid in maintaining sterility, ease of opening, and reduce risk of dosing errors or contamination during infusion therapy.
Regulatory Compliance: Helps manufacturers and distributors meet European regulatory and quality requirements for medical devices, improving safety and interoperability between products from different suppliers.
Related Standards
ISO 8536 Series: SIST EN ISO 8536-3:2009/A1:2022 is part of a comprehensive set of standards covering infusion sets and related equipment, including:
- Part 1: Infusion sets for single use
- Part 2: Connectors for infusion sets
- Other parts addressing different components and materials for infusion devices
CEN and ISO Collaboration: The amendment is subject to the Vienna Agreement between ISO and CEN, ensuring coordinated development and alignment of European and international standards in medical device manufacturing.
Regulatory and Quality Standards: Often used alongside ISO 13485 (medical devices quality management systems) and EU MDR (Medical Device Regulation) for ensuring product safety and regulatory compliance in healthcare markets.
Keywords: SIST EN ISO 8536-3:2009/A1:2022, aluminium caps, infusion bottles, infusion equipment, medical use, standard amendment, CEN, ISO TC 76, medical device manufacturing, infusion therapy, medical packaging standards, European medical standards, infusion bottle sealing.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2022
Infuzijska oprema za uporabo v medicini - 3. del: Aluminijeve zaporke za infuzijske
steklenice - Dopolnilo A1 (ISO 8536-3:2009/Amd 1:2022)
Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles -
Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
Infusionsgeräte zur medizinischen Verwendung - Teil 3: Aluminium-Bördelkappen für
Infusionsflaschen - Änderung 1 (ISO 8536-3:2009/Amd 1:2022)
Matériel de perfusion à usage médical - Partie 3: Capsules en aluminium pour flacons de
perfusion - Amendement 1 (ISO 8536-3:2009/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 8536-3:2009/A1:2022
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 8536-3:2009/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 3: Aluminium
caps for infusion bottles - Amendment 1 (ISO 8536-
3:2009/Amd 1:2022)
Matériel de perfusion à usage médical - Partie 3: Infusionsgeräte zur medizinischen Verwendung - Teil
Capsules en aluminium pour flacons de perfusion - 3: Aluminium-Bördelkappen für Infusionsflaschen -
Amendement 1 (ISO 8536-3:2009/Amd 1:2022) Änderung 1 (ISO 8536-3:2009/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 8536-3:2009; it was approved by CEN on 19 March 2022.
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-3:2009/A1:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8536-3:2009/A1:2022) 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 CCMC.
This Amendment to the European Standard EN ISO 8536-3:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by March 2023, and
conflicting national standards shall be withdrawn at the latest by March 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 8536-3:2009/Amd 1:2022 has been approved by CEN as EN ISO 8536-3:2009/A1:2022
without any modification.
...
Frequently Asked Questions
SIST EN ISO 8536-3:2009/A1:2022 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)". This standard covers: No scope available
No scope available
SIST EN ISO 8536-3:2009/A1:2022 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/A1:2022 has the following relationships with other standards: It is inter standard links to SIST EN ISO 8536-3:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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