SIST EN ISO 8536-4:2013
(Main)Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010)
Dieser Teil von ISO 8536 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Infusionsgeräte für Schwerkraftinfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Infusionslösungen und Geräten zur intravenösen Punktion geeignet sind.
Sekundäres Ziel dieses Teils von ISO 8536 ist eine Anleitung zu Festlegungen bezüglich Qualität und Leistungsfähigkeit der Werkstoffe, die für Infusionsgeräte verwendet werden. Außerdem werden Benennun¬gen für die Einzelteile von Infusionsgeräten angegeben.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 8536.
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2010)
L'ISO 8536-4:2010 spécifie les exigences applicables aux appareils de perfusion à usage médical, non réutilisables, à alimentation par gravité, afin d'assurer leur compatibilité avec les récipients contenant des solutions de perfusion et avec les appareils intraveineux.
Le deuxième objectif de l'ISO 8536-4:2010 est de donner des directives sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de perfusion et de proposer une terminologie concernant les composants de ces derniers.
Dans certains pays, la pharmacopée nationale ou d'autres règlements nationaux ont force d'obligation et ont priorité sur l'ISO 8536-4:2010.
Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2010)
Ta del standarda ISO 8536 določa zahteve za infuzijske sete za enkratno uporabo, delujoče na osnovi gravitacije, za uporabo v medicini za zagotavljanje združljivosti z vsebniki za infuzijske raztopine in intravenozno opremo. Druga cilja tega dela standarda ISO 8536 sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za infuzijske sete, ter predstaviti oznake za sestavne dele transfuzijskih setov. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8536-4:2013
01-maj-2013
1DGRPHãþD
SIST EN ISO 8536-4:2010
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO ,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERGHOXMRþLQDRVQRYLJUDYLWDFLMH ,62
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2010)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2010)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2013
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-4:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8536-4:2013
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SIST EN ISO 8536-4:2013
EUROPEAN STANDARD
EN ISO 8536-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 11.040.20 Supersedes EN ISO 8536-4:2010
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2010)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2010) Verwendung (ISO 8536-4:2010)
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 8536-4:2013: E
worldwide for CEN national Members.
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SIST EN ISO 8536-4:2013
EN ISO 8536-4:2013 (E)
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
2
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SIST EN ISO 8536-4:2013
EN ISO 8536-4:2013 (E)
Foreword
The text of ISO 8536-4:2010 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 8536-4:2013 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 8536-4:2010.
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 8536-4:2010 has been approved by CEN as EN ISO 8536-4:2013 without any modification.
3
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SIST EN ISO 8536-4:2013
EN ISO 8536-4:2013 (E)
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) of
Qualifying remarks/Notes
European Standard Directive 93/42/EEC
6.1, 6.7, 8.3, 8.4, 8.5 7.2
8.1 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.
6.2, 6.4, 6.5 7.6
6.11, 6.13 8
3.2 8.1
10 8.3
8.2 8.4
6.3, 6.12 9.1
6.9, 6.10 10
6.3 12.7.1
6.6, 6.8, 6.9, 6.10 12.8
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.
4
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SIST EN ISO 8536-4:2013
INTERNATIONAL ISO
STANDARD 8536-4
Fifth edition
2010-10-01
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
Matériel de perfusion à usage médical —
Partie 4: Appareils de perfusion non réutilisables, à alimentation par
gravité
Reference number
ISO 8536-4:2010(E)
©
ISO 2010
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 General requirements .1
4 Designation .4
4.1 Infusion set .4
4.2 Air-inlet device.4
5 Materials .4
6 Physical requirements .5
6.1 Particulate contamination.5
6.2 Leakage .5
6.3 Tensile strength.5
6.4 Closure-piercing device.5
6.5 Air-inlet device.5
6.6 Tubing.6
6.7 Fluid filter .6
6.8 Drip chamber and drip tube.6
6.9 Flow regulator.6
6.10 Flow rate of infusion fluid.6
6.11 Injection site.6
6.12 Male conical fitting .6
6.13 Protective caps .6
7 Chemical requirements.7
7.1 Reducing (oxidizable) matter .7
7.2 Metal ions .7
7.3 Titration acidity or alkalinity.7
7.4 Residue on evaporation.7
7.5 UV absorption of extract solution.7
8 Biological requirements.7
8.1 General .7
8.2 Sterility.7
8.3 Pyrogenicity .7
8.4 Haemolysis.7
8.5 Toxicity .8
9 Labelling.8
9.1 Unit container .8
9.2 Shelf or multi-unit container .8
10 Packaging.9
Annex A (normative) Physical tests.10
Annex B (normative) Chemical tests .14
Annex C (normative) Biological tests .16
Bibliography.17
© ISO 2010 – All rights reserved iii
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(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.
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 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This fifth edition cancels and replaces the fourth edition (ISO 8536-4:2007), of which it constitutes a minor
revision. In detail, 7.1 was more clarified in alignment with B.2, and A.2.2 was changed in order to go back
with the leakage test pressure to 20 kPa and to restrict the leakage test for (40 ± 1) °C.
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
iv © ISO 2010 – All rights reserved
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SIST EN ISO 8536-4:2013
INTERNATIONAL STANDARD ISO 8536-4:2010(E)
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
1 Scope
This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order
to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and
performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take
precedence over this part of ISO 8536.
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 edition of the referenced
document (including any amendments) applies.
ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
1)
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
2)
be supplied — Part 1: General requirements
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given
in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet
devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated
in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated in Figure 2 used
1) Under preparation. (Revision of ISO 14644-1:1999)
2) To be published. (Revision of ISO 15223-1:2007)
© ISO 2010 – All rights reserved 1
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used
for rigid containers.
3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set
until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing
device or needle.
Key
1 protective cap of closure-piercing device 7 fluid filter
2 closure-piercing device 8 tubing
3 air inlet with air filter and closure 9 flow regulator
4 fluid channel 10 injection site
5 drip tube 11 male conical fitting
6 drip chamber 12 protective cap of male conical fitting
a
Closure of the air inlet is optional.
b
The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a
nominal pore size of 15 µm.
c
The injection site is optional.
Figure 1 — Example of a vented infusion set
2 © ISO 2010 – All rights reserved
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
Key
1 protective cap of closure-piercing device 7 tubing
2 closure-piercing device 8 flow regulator
3 fluid channel 9 injection site
4 drip tube 10 male conical fitting
5 drip chamber 11 protective cap of the male conical fitting
6 fluid filter
a
The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a
nominal pore size of 15 µm.
b
The injection site is optional.
Figure 2 — Example of a non-vented infusion set
© ISO 2010 – All rights reserved 3
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
Key
1 protective cap 4 clamp
2 closure-piercing device or needle 5 air-inlet with air filter
3 tubing
a
Other designs are acceptable if the same safety aspects are ensured.
Figure 3 — Example of an air-inlet device
4 Designation
4.1 Infusion set
Infusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the
descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the
letter G:
Infusion set ISO 8536-4 - IS - G
4.2 Air-inlet device
Air-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the
descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the
letters AD:
Air-inlet device ISO 8536-4 - IS - AD
5 Materials
The materials from which the infusion set and its components are manufactured (as described in Clause 3)
shall comply with the requirements specified in Clause 6. Where components of the infusion set come into
contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8.
4 © ISO 2010 – All rights reserved
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
6 Physical requirements
6.1 Particulate contamination
The infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts
shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of
particles shall not exceed the contamination index limit.
6.2 Leakage
The infusion set, when tested in accordance with A.2, shall show no signs of air leakage.
6.3 Tensile strength
When tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile
force of not less than 15 N for 15 s.
6.4 Closure-piercing device
The dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4.
NOTE The dimension of 15 mm in Figure 4 is a reference measurement. The cross-section of the piercing device at
this site is a circle.
The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container
without pre-piercing. No coring should occur during this procedure.
Dimensions in millimetres
Figure 4 — Dimensions of the closure-piercing device
6.5 Air-inlet device
The air-inlet device shall conform to 3.2 and 8.2.
The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the
container into which the device is to be inserted.
The air-inlet device shall be separate from, or integral with, the closure-piercing device.
When the air-inlet device is inserted into a rigid infusion container, the air admitted into the container shall not
become entrained in the liquid outflow.
The air filter shall be fitted such that all air entering the rigid container passes through it, and such that the flow
of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance
with A.4.
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
6.6 Tubing
The tubing, made of flexible material, shall be transparent or sufficiently translucent that the interface of air
and water during the passage of air bubbles can be observed with normal or corrected vision.
The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length, including the
injection site, when provided, and the male conical fitting.
6.7 Fluid filter
The infusion set shall be provided with a fluid filter.
When tested in accordance with A.5, the retention of latex particles on the filter shall be not less than 80 %.
6.8 Drip chamber and drip tube
The drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip
chamber through a tube that projects into the chamber. There shall be a distance of not less than 40 mm
between the end of the drip tube and the outlet of the chamber, or a distance of not less than 20 mm between
the drip tube and the fluid filter. The wall of the drip chamber shall not be closer than 5 mm to the end of the
drip tube. The drip tube shall be such that 20 drops of distilled water or 60 drops of distilled water at
(23 ± 2) °C at a flow rate of (50 ± 10) drops/min deliver a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g. The
drip chamber should permit and facilitate the priming procedure.
6.9 Flow regulator
The flow regulator shall adjust the flow of the infusion solution between zero and the maximum. The flow
regulator should be capable of continuous use throughout an infusion without the tubing being damaged.
There should be no deleterious reaction between the flow regulator and the tubing when they are stored in
such a way that there is contact.
6.10 Flow rate of infusion fluid
The infusion set shall deliver not less than 1 000 ml of a sodium chloride solution [mass concentration
ρ(NaCl) = 9 g/l] in 10 min under a static head of 1 m.
6.11 Injection site
When provided, the self-sealing injection site shall reseal when tested in accordance with A.6, and there shall
be no leakage of more than one falling drop of water. The injection site should be located near the male
conical fitting.
6.12 Male conical fitting
The distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 594-1 or ISO 594-2.
Luer lock fittings in accordance with ISO 594-2 should preferably be used.
6.13 Protective caps
The protective caps at the end of the infusion set shall maintain the sterility of the closure-piercing device, the
male conical fitting and the interior of the infusion set. Protective caps should be secure but easily removable.
6 © ISO 2010 – All rights reserved
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SIST EN ISO 8536-4:2013
ISO 8536-4:2010(E)
7 Chemical requirements
7.1 Reducing (oxidizable) matter
When tested in accordance with B.2, the difference of volume of Na S O solution [c(Na S O ) = 0,005 mol/l]
2 2 3 2 2 3
for the extract solution S and of volume of Na S O solution for blank solution S shall not exceed 2,0 ml.
1 2 2 3 0
7.2 Metal ions
The extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead and tin, and not
more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an equivalent
method.
When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not exceed
2+
that of the standard matching solution with a mass concentration ρ (Pb ) = 1 µg/ml.
7.3 Titration acidity or alkalinity
When tested in accordance with B.4, not more than 1 ml of either standar
...
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