SIST EN ISO 1135-4:2012
(Main)Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
ISO 1135‑4:2010 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of ISO 1135‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135‑4:2010.
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-4:2010)
Dieser Teil von ISO 1135 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische
Transfusionsgeräte fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Blut und Blutbestandteile
und Geräten zur intravenösen Punktion geeignet sind.
Zweitrangige Ziele dieses Teils von ISO 1135 sind die Schaffung einer Anleitung zu Spezifikationen der
Qualität und Leistungsfähigkeit von Werkstoffen, die für Transfusionsgeräte verwendet werden, und die
Angabe von Benennungen für Einzelteile von Transfusionsgeräten.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und
haben Vorrang vor diesem Teil von ISO 1135.
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables (ISO 1135-4:2010)
L'ISO 1135-4:2010 sp�cifie les exigences applicables aux appareils de transfusion � usage m�dical, non r�utilisables, afin d'assurer leur compatibilit� avec les conteneurs renfermant du sang et des composants du sang, ainsi qu'avec les appareils intraveineux.
Le deuxi�me objectif de l'ISO 1135-4:2010 est de donner des directives sur les sp�cifications relatives � la qualit� et aux performances des mat�riaux utilis�s dans les appareils de transfusion, et de proposer une terminologie relative aux composants de ces derniers.
Dans certains pays, la pharmacop�e nationale ou d'autres r�glementations nationales sont l�galement contraignantes et priment sur l'ISO 1135-4:2010.
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo (ISO 1135-4:2010)
Ta del ISO 1135 opredeljuje zahteve za transfuzijske garniture za enkratno uporabo v medicini, da se zagotovi njihova združljivost z vsebniki za kri in krvne sestavine ter z intravenozno opremo. Drugotni cilji tega dela ISO 1135 so zagotoviti napotke glede specifikacij, ki se nanašajo na kakovost in delovanje materialov, ki se uporabljajo v transfuzijskih garniturah, in predstaviti oznake za sestavne dele transfuzijskih garnitur. V nekaterih državah so farmakopeja države ali drugi predpisi države pravno zavezujoči in imajo prednost pred tem delom ISO 1135.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 1135-4:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 1135-4:2010
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2010)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2010)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2010)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2010)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 1135-4:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 1135-4:2012
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SIST EN ISO 1135-4:2012
EUROPEAN STANDARD
EN ISO 1135-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.040.20 Supersedes EN ISO 1135-4:2010
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2010)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung - Teil 4:
Appareils de transfusion non réutilisables (ISO 1135- Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-
4:2010) 4:2010)
This European Standard was approved by CEN on 20 September 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 Ref. No. EN ISO 1135-4:2011: E
worldwide for CEN national Members.
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2011 (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 1135-4:2012
EN ISO 1135-4:2011 (E)
Foreword
This document (EN ISO 1135-4:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use" in collaboration with 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 April 2012, and conflicting national standards shall be withdrawn at the
latest by April 2012.
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 1135-4:2010.
This new edition contains a revised Annex ZA.
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, 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 1135-4:2010 has been approved by CEN as EN ISO 1135-4:2011 without any modification.
3
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2011 (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) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6, 7.1, 7.3, 7.4, 7.5 7.1 Only chemical toxicity is
addressed (in Clause 6).
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
standards (in Clause 7.1)
Prevention of pyrogenicity
covered (in Clause 7.3)
Prevention of haemolysis
covered (in Clause 7.4)
Prevention of toxicity covered (in
Clause 7.5)
3.2, 5.1, 5.6, 6, 7.1, 7.3, 7.4, 7.5 7.2 The part of ER 7.2 relating to
packaging is not addressed (Æ
for packaging see Clause 9 of
this standard).
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
standards (in Clause 7.1)
Prevention of pyrogenicity
covered (in Clause 7.3)
Prevention of haemolysis
covered (in Clause 7.4)
Prevention of toxicity covered (in
4
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2011 (E)
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
Clause 7.5)
6, 7.1 7.3 Only the first half sentence of ER
7.3 is addressed.
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
standards (in Clause 7.1)
6, 7.1 7.5 Only the first sentence is
covered.
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
standards (in Clause 7.1).
3.2, 5.2, 5.4 7.6
3.2, 5.10, 5.12 8.1 The part of ER 8.1 relating to
handling is not addressed.
Manufacturing processes are not
covered.
The reduction of the risk of
infection is not fully covered.
9 8.3 Only packaging related
protection of sterility is covered.
7.2 8.4 Only the sterilisation method is
covered.
5.3, 5.11 9.1 The second sentence of ER 9.1
is not addressed.
5.7, 5.8, 5.9 10.1 Information relating to the limits
of accuracy is not addressed.
5.3 12.7.1 Only tensile strength is
addressed.
5.5, 5.7, 5.8, 5.9 12.8.1
5.5, 5.7, 5.8, 5.9 12.8.2 Only the first paragraph is
addressed.
8 13.1
8 13.2
5
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2011 (E)
Clause(s)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.3, 8 13.3 The part of 13.3a) relating to the
authorized representative is not
addressed. Presumption of
conformity to the rest of 13.3a) is
only provided if the name and
address of the manufacturer are
given.
13.3b) is addressed in Clause
3.3.
13.3d) is only covered if the
batch number is preceded by the
word 'LOT'.
13.3f) relating to single use is
not addressed.
8 13.4 Only addressed regarding the
label.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
6
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SIST EN ISO 1135-4:2012
INTERNATIONAL ISO
STANDARD 1135-4
Fourth edition
2010-04-15
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables
Reference number
ISO 1135-4:2010(E)
©
ISO 2010
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 General requirements .2
3.1 Nomenclature for components of the transfusion set .2
3.2 Maintenance of sterility.3
3.3 Designation .3
4 Materials .3
5 Physical requirements .3
5.1 Particulate contamination.3
5.2 Leakage .3
5.3 Tensile strength.3
5.4 Closure-piercing device.3
5.5 Tubing.4
5.6 Filter for blood and blood components .4
5.7 Drip chamber and drip tube.4
5.8 Flow regulator.4
5.9 Flow rate of blood and blood components.4
5.10 Injection site.5
5.11 Male conical fitting .5
5.12 Protective caps .5
6 Chemical requirements.5
6.1 Reducing (oxidizable) matter .5
6.2 Metal ions .5
6.3 Titration acidity or alkalinity.5
6.4 Residue on evaporation.5
6.5 UV absorption of extract solution.5
7 Biological requirements.6
7.1 General .6
7.2 Sterility.6
7.3 Pyrogenicity .6
7.4 Haemolysis.6
7.5 Toxicity .6
8 Labelling.6
8.1 Unit container .6
8.2 Shelf or multi-unit container .7
9 Packaging.7
10 Disposal.7
Annex A (normative) Physical tests.8
Annex B (normative) Chemical tests .12
Annex C (normative) Biological tests .14
Bibliography.15
© ISO 2010 – All rights reserved iii
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(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 1135-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use, and by Technical Committee CEN/TC 205, Non-active medical devices in
collaboration.
This fourth edition cancels and replaces the third edition (ISO 1135-4:2004), which has been revised at
Clause A.1 (Test for particulate contamination). In addition, all requirements regarding the no-longer-used air
inlet device have been deleted. Finally, 5.4 has been revised to improve compatibility between the closure-
piercing device and blood bag ports.
ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use:
⎯ Part 3: Blood-taking set
⎯ Part 4: Transfusion sets for single use
iv © ISO 2010 – All rights reserved
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SIST EN ISO 1135-4:2012
INTERNATIONAL STANDARD ISO 1135-4:2010(E)
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
1 Scope
This part of ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure
their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and
performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take
precedence over this part of ISO 1135.
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 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 3826-1:2003, Plastics collapsible containers for human blood and blood components — Part 1:
Conventional containers
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
1)
ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
1) To be published. (Revision of ISO 15223-1:2007)
© ISO 2010 – All rights reserved 1
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(E)
3 General requirements
3.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 1.
Key
1 protective cap of the 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 filter for blood and blood components
a
Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable if the same
safety aspects are ensured.
b
Injection site is optional.
Figure 1 — Example of a transfusion set
2 © ISO 2010 – All rights reserved
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(E)
3.2 Maintenance of sterility
The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set
until the set is used.
3.3 Designation
A transfusion set complying with the requirements of this part of ISO 1135 is designated as follows.
Transfusion set ISO 1135-4
4 Materials
The materials from which the transfusion sets given in Clause 3 are manufactured shall comply with the
requirements specified in Clause 5. If components of the transfusion set come into contact with blood and
blood components, they shall additionally comply with the requirements specified in Clauses 6 and 7.
5 Physical requirements
5.1 Particulate contamination
The transfusion 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 detected shall not exceed the contamination index limit.
5.2 Leakage
The transfusion set, when tested in accordance with A.2, shall show no signs of air leakage.
5.3 Tensile strength
Any connections between the components of the transfusion set, excluding protective caps, shall withstand a
static tensile force of not less than 15 N for 15 s.
5.4 Closure-piercing device
5.4.1 The dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 2.
NOTE The dimension of 15 mm in Figure 2 is a reference measurement. The cross-section of the piercing device at
this site is a circle.
Dimensions in millimetres
Figure 2 — Dimensions of the closure-piercing device
© ISO 2010 – All rights reserved 3
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(E)
5.4.2 The closure-piercing device shall be capable of piercing and penetrating the closure of a container for
blood and blood components without prepiercing. No coring should occur during this procedure.
NOTE 1 A carefully controlled surface treatment of the closure-piercing device (e.g. siliconization) is recommended to
facilitate its insertion into the blood bag port. The same effect may be achieved by a careful selection of material for the
closure-piercing device. Typical results including test equipment for penetration forces between spikes and blood bag
ports have been published. See references [11] and [12].
NOTE 2 A central closure-piercing device tip is preferred to an asymmetric design in order to aid its insertion.
5.4.3 When inserted into a blood bag port conforming to ISO 3826-1, the closure-piercing device shall resist
a pull force of 15 N for 15 s.
5.4.4 When tested in accordance with ISO 3826-1:2003, 5.3, the connection between the closure-piercing
device and the blood bag port shall show no evidence of leakage.
5.5 Tubing
5.5.1 The tubing, made of flexible material, shall be transparent or sufficiently translucent so that the
interface of air and water during the passage of air bubbles can be observed with normal or corrected-to-
normal vision.
5.5.2 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.
5.6 Filter for blood and blood components
The transfusion set shall be provided with a filter for blood and blood components. The filter shall have
2
uniform pores and shall cover a total area of not less than 10 cm . When tested in accordance with A.3.2, the
mass of solid material retained on the filter shall be not less than 80 % (mass fraction) of that retained on the
reference filter.
5.7 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 which 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 filter for blood and blood components. 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 at (23 ± 2) °C
and at a flow rate of (50 ± 10) drops/min deliver (1 ± 0,1) ml [(1 ± 0,1) g].
The drip chamber should permit and facilitate the procedure of priming.
5.8 Flow regulator
The flow regulator shall adjust the flow of the blood and blood components between zero and maximum.
The flow regulator should be capable of continuous use throughout a transfusion without the tubing being
damaged. There should be no deleterious reaction between the flow regulator and the tubing when stored in
such a manner that there is contact.
5.9 Flow rate of blood and blood components
The transfusion set shall deliver not less than 1 000 ml of blood at (23 ± 2) °C in 30 min with a pressure
difference of 10 kPa. The transfusion set shall also deliver not less than 500 ml of blood in 2 min under a
pressure of 30 kPa above atmospheric pressure.
The blood shall be collected into a suitable anticoagulant solution and stored for not less than 2 weeks, and be
free of large clots.
4 © ISO 2010 – All rights reserved
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SIST EN ISO 1135-4:2012
ISO 1135-4:2010(E)
5.10 Injection site
When provided, the self-sealing injection site shall reseal when tested in accordance with A.4, 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.
5.11 Male conical fitting
The distal end of the tubing shall terminate in a male conical fitting conforming with ISO 594-1 or ISO 594-2.
Luer lock fittings in accordance with ISO 594-2 should be used.
5.12 Protective caps
The protective caps at the end of the transfusion set shall maintain the sterility of the closure-piercing device,
the male conical fitting and the interior of the transfusion set.
Protective caps should be secure but easily removable.
6 Chemical requirements
6.1 Reducing (oxidizable) matter
When tested in accordance with B.2, the total amount of potassium permanganate solution
[c(KMnO ) = 0,002 mol/l] used shall not exceed 2,0 ml.
4
6.2 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 containi
...
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