SIST EN ISO 8536-5:2013
(Main)Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)
- Abstract
ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.
ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials.
In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.
- Status
- Published
- Publication Date
- 15-Apr-2013
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 05-Mar-2013
- Due Date
- 10-May-2013
- Completion Date
- 16-Apr-2013
- Directive
- 93/42/EEC - Medical devices
SIST EN ISO 8536-5:2013 is the Slovenian standard identical to EN ISO 8536-5:2013, which adopts ISO 8536-5:2004. It specifies requirements for burette infusion sets for single use, gravity feed, used in medical infusion equipment, mainly for 50 ml, 100 ml and 150 ml nominal capacities.
What does SIST EN ISO 8536-5:2013 specify?
SIST EN ISO 8536-5:2013 sets requirements for single-use, gravity-feed burette infusion sets so they work compatibly with infusion-solution containers and intravenous equipment. It also gives guidance on material quality and performance for the parts used in these sets.
The standard is organized into a short technical core:
- Clause 1 Scope
- Clause 2 Normative references
- Clause 3 General requirements
- Clause 4 Designation
- Clause 5 Materials
- Clause 6 Physical requirements
- Clauses 7 to 10 Chemical requirements, Biological requirements, Labelling, and Packaging
- Informative Annex ZA on the link to EU medical-device requirements
| Annex | What it covers |
|---|---|
| ZA | Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices |
What are the key requirements of SIST EN ISO 8536-5:2013?
SIST EN ISO 8536-5:2013 focuses on the design, materials, and basic performance features that affect safe use and compatibility in infusion practice.
- Clause 3.1 says the component names are given in Figure 1, and it shows example configurations of a burette infusion set. In practice, this gives manufacturers and inspectors a common vocabulary for the parts they are specifying or checking.
- Clause 3.2 requires protective caps to keep the internal parts sterile until use. This matters because the set is used directly in a medical fluid path.
- Clause 3.3 requires any separate air-inlet device to comply with ISO 8536-4. That means the air entry function is not free to vary if a separate device is used.
- Clause 4 defines the designation format: burette set, ISO 8536-5 reference, nominal capacity in millilitres, and gravity-feed indication. This is what appears in ordering, labelling, and procurement documents.
- Clause 5 requires the materials for the set and its components to meet the physical requirements in Clause 6, and any parts that contact solutions to meet Clauses 7 and 8 as well. In practice, material choice is not only a manufacturing issue - it also affects contact with infusion fluids.
- Clause 6.2 requires the burette to be rigid or semi-rigid plastics, to allow visual observation of fluid, to have filtered air venting above the top graduation mark, and to be able to act as a separate self-vented reservoir. These features affect filling, reading, and controlled delivery.
- Clause 6.4 controls the graduated scale: the scale intervals, line quality, numbering, and the zero mark position are all specified. This is important because the user must be able to read delivered volume accurately.
- Clauses 7 to 10 point back to ISO 8536-4 for chemical, biological, labelling, and packaging requirements. That keeps the broader safety and information requirements aligned with the companion gravity-feed infusion-set standard.
What terms does SIST EN ISO 8536-5:2013 define?
- Burette infusion set - A single-use infusion set with a graduated burette chamber used to control and measure fluid delivery by gravity.
- Gravity feed - Delivery of infusion fluid by gravity rather than by a pump or pressure source.
- Nominal capacity - The stated burette volume used to identify the set, such as 50 ml, 100 ml, or 150 ml.
- Protective cap - A cap that keeps the internal parts of the set protected and sterile before use.
- Filtered air-venting capability - An air inlet that includes filtration so the burette can vent air while controlling contamination risk.
- Self-vented reservoir - A reservoir arrangement that can receive fluid and then be closed off while maintaining its own venting function.
- BS - The designation abbreviation for burette set used in Clause 4.
- G - The designation abbreviation for gravity feed used in Clause 4.
Who uses SIST EN ISO 8536-5:2013?
SIST EN ISO 8536-5:2013 is used by manufacturers of medical infusion equipment, component suppliers, and quality teams that specify or verify burette infusion sets. It is also useful for purchasers, inspection staff, and test laboratories that need a common technical basis for compatibility, material checks, and product designation.
The standard sits in the medical-device field, especially transfusion, infusion and injection equipment. That makes it relevant wherever single-use gravity-feed infusion sets are designed, sourced, or assessed.
What changed in SIST EN ISO 8536-5:2013 from the previous edition?
SIST EN ISO 8536-5:2013 supersedes EN ISO 8536-5:2011. The underlying ISO text is the second edition of ISO 8536-5 and it cancels and replaces ISO 8536-5:1992 as a technically revised edition.
Which standards are used with SIST EN ISO 8536-5:2013?
- ISO 8536-4 - This is the normative reference used for general physical requirements where applicable, and for the chemical, biological, labelling, and packaging requirements that Clauses 7 to 10 adopt by reference.
- EN ISO 10993 series - Annex ZA mentions this series as a route for biological evaluation when a manufacturer chooses to apply it in support of EU medical-device conformity.
What does the SIST EN ISO 8536-5:2013 document contain?
The document includes one example figure of a burette set configuration and one figure showing typical graduated scales. Table 1 sets the scale-interval rules and the tolerance on graduated capacity for the burette.
Annex ZA gives a clause-by-clause mapping to EU Directive 93/42/EEC, which is useful for regulatory assessment and conformity work. The rest of the text is short and practical, with requirements aimed at design, identification, material selection, and reading the delivered volume correctly.
Relations
- Effective Date
- 01-May-2013
- Effective Date
- 06-Dec-2023
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Frequently Asked Questions
SIST EN ISO 8536-5:2013 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)". This standard covers: ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.
ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.
SIST EN ISO 8536-5:2013 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 8536-5:2013 has the following relationships with other standards: It is inter standard links to SIST EN ISO 8536-5:2012, kSIST FprEN ISO 8536-5:2026. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 8536-5:2013 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN ISO 8536-5:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2013
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SIST EN ISO 8536-5:2012
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Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity
feed (ISO 8536-5:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 5: Infusionsgeräte mit
Dosierbehälter für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-5:2004)
Matériel de perfusion à usage médical - Partie 5: Appareils non réutilisables de perfusion
à burette, à alimentation par gravité (ISO 8536-5:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-5:2013
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 8536-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 11.040.20 Supersedes EN ISO 8536-5:2011
English Version
Infusion equipment for medical use - Part 5: Burette infusion
sets for single use, gravity feed (ISO 8536-5:2004)
Matériel de perfusion à usage médical - Partie 5: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 5:
non réutilisables de perfusion à burette, à alimentation par Infusionsgeräte mit Dosierbehälter für
gravité (ISO 8536-5:2004) Schwerkraftinfusionen zur einmaligen Verwendung (ISO
8536-5:2004)
This European Standard was approved by CEN on 8 January 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-5:2013: E
worldwide for CEN national Members.
Contents
Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices . 4
Foreword
The text of ISO 8536-5:2004 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 8536-5:2013 by 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
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 8536-5:2011.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8536-5:2004 has been approved by CEN as EN ISO 8536-5:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC on medical devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.2, 8 7.2
8 7.5 Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
of standards. However, the part
of ER 7.5 relating to phthalates
is not specifically addressed in
the EN ISO 10993 series.
3.3, 6.2.2, 6.2.3 7.6
3.2 8.1
10 8.3
8 8.4 Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the EN ISO 10993 series
of standards. However, the part
of ER 7.5 relating to phthalates
is not specifically addressed in
the EN ISO 10993 series.
6.1 9.1
6.3, 6.4 10
6.1 12.7.1
6.2.1 12.8
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
9 13 The part of ER 13.3 a) relating to
the authorized representative is
not addressed.
ERs 13.3 f) and 13.6 h) relating
to single-use are not fully
addressed.
ER 13.6 q) is not addressed.
4 13.3
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 8536-5
Second edition
2004-02-01
Infusion equipment for medical use —
Part 5:
Burette infusion sets for single use,
gravity feed
Matériel de perfusion à usage médical —
Partie 5: Appareils non réutilisables de perfusion à burette, à
alimentation par gravité
Reference number
ISO 8536-5:2004(E)
©
ISO 2004
ISO 8536-5:2004(E)
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