SIST EN ISO 8638:2014
(Main)Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard does not apply to:
- haemodialysers, haemodiafilters or haemofilters;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010)
Diese Internationale Norm legt Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren (nachstehend als „das Gerät“ bezeichnet) sowie (integrale und nicht integrale) Schutzvorrichtungen für Messwandler („Transducer-Protector“) für die Anwendung bei Hämodialyse, Hämodiafiltration und Hämofiltration fest.
Die vorliegende Internationale Norm ist nicht anwendbar auf:
- Hämodialysatoren, Hämodiafilter oder Hämofilter;
- Plasmafilter;
- Hämoperfusionsgeräte;
- Geräte für den vaskulären Zugang;
- Blutpumpen;
- Druckaufzeichnungsgeräte für extrakorporale Blutkreisläufe;
- Luftnachweisgeräte;
- Systeme für die Herstellung, Aufbewahrung oder Überwachung der Dialyseflüssigkeit;
- Systeme oder Ausrüstungen für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzent¬ration.
ANMERKUNG Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren sind in ISO 8637 festgelegt.
Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8638:2010)
L'ISO 8638:2010 spécifie des exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (appelés ci-après «dispositifs») et aux dispositifs de protection des capteurs (intégrés et non intégrés) utilisables dans le cadre d'opérations d'hémodialyse, d'hémodiafiltration et d'hémofiltration.
Vsadki (implantati) za srce in ožilje ter zunajtelesni pretočni sistemi - Zunajtelesni krvni obtok za hemodializatorje, hemodiafiltre in hemofiltre (ISO 8638:2010)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8638:2014
01-april-2014
1DGRPHãþD
SIST EN 1283:2000
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMHWHU]XQDMWHOHVQLSUHWRþQLVLVWHPL=XQDMWHOHVQL
NUYQLREWRN]DKHPRGLDOL]DWRUMHKHPRGLDILOWUHLQKHPRILOWUH ,62
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf
bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010)
Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel
pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8638:2010)
Ta slovenski standard je istoveten z: EN ISO 8638:2014
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 8638:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8638:2014
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SIST EN ISO 8638:2014
EUROPEAN STANDARD
EN ISO 8638
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2014
ICS 11.040.40 Supersedes EN 1283:1996
English Version
Cardiovascular implants and extracorporeal systems -
Extracorporeal blood circuit for haemodialysers, haemodiafilters
and haemofilters (ISO 8638:2010)
Implants cardiovasculaires et systèmes extracorporels - Kardiovaskuläre Implantate und extrakorporale Systeme -
Circuit sanguin extracorporel pour les hémodialyseurs, les Extrakorporaler Blutkreislauf bei Hämodialysatoren,
hémodiafiltres et les hémofiltres (ISO 8638:2010) Hämodiafiltern und Hämofiltern (ISO 8638:2010)
This European Standard was approved by CEN on 1 December 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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8638:2014 E
worldwide for CEN national Members.
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SIST EN ISO 8638:2014
EN ISO 8638:2014 (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 8638:2014
EN ISO 8638:2014 (E)
Foreword
The text of ISO 8638:2010 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organisation for Standardization (ISO) and has been taken over as EN ISO 8638:2014 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 July 2014, and conflicting national standards shall be withdrawn at the
latest by July 2014.
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 1283:1986.
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(s).
For relationship with EU Directive(s), 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 8638:2010 has been approved by CEN as EN ISO 8638:2014 without any modification.
3
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SIST EN ISO 8638:2014
EN ISO 8638:2014 (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)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4.1, 4.2, 4.3 7.2
4.1 7.3
4.1, 6.3(q) 7.5 Addressed only in general terms.
Although these devices can
incorporate materials containing
phthalates, there is no specific
requirement that the presence of
phthalates be indicated in the
labelling.
4.4.1, 4.4.9 7.6
4.2, 4.4.1, 4.4.6, 4.4.9, 6.2(e), 8.1
6.2(j), 6.4(f), 6.4(i), 6.4(n)
4.2, 5.3 8.3 Addressed only in general terms.
4.2, 5.3 8.4
4.4.2, 4.4.3, 4.4.4, 4.4.9.2 9.1 Connectors are specified to
match tubing connectors
specified in ISO 8637 for the
blood compartment.
4.4.6.1, 4.4.10, 4.6 9.2
6 13.1
6.1, 6.2, 6.3, 6.4 13.2 The NOTE at the end of each
clause allows the use of symbols
from Harmonized Standards.
6.2(a), 6.3(a), 6.3(b), 6.4(a) 13.3 (a)
6.2(b), 6.2(c), 6.3(c), 6.3(d), 13.3 (b)
6.4(b), 6.4(c)
6.2(e), 6.3(f), 6.4(d) 13.3 (c)
4
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SIST EN ISO 8638:2014
EN ISO 8638:2014 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.2(d), 6.3(e) 13.3 (d)
6.2(f), 6.3(g) 13.3 (e)
6.2(g), 6.4(e) 13.3 (f)
6.3(h) 13.3 (i)
6.2(j), 6.4(g), 6.4(i), 6.4(l), 13.3 (j)
6.4(m), 6.4(o)
6.2(j), 6.4(f) 13.3 (k)
6.2(i) 13.3 (m)
6.4(a), 6.4(b), 6.4(c), 6.4(d), 13.6 (a) There is no requirement for the
6.4(e), 6.4(f), 6.4(g), 6.4(i), 6.4(l), information in 13.3(i) in the
instructions for use. Instead, that
6.4(m), 6.4(o)
information is required to be
given on the outer container in
which the device is sold.
6.4(r) 13.6 (c)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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SIST EN ISO 8638:2014
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SIST EN ISO 8638:2014
INTERNATIONAL ISO
STANDARD 8638
Third edition
2010-07-01
Cardiovascular implants and
extracorporeal systems — Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
Implants cardiovasculaires et systèmes extracorporels — Circuit
sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les
hémofiltres
Reference number
ISO 8638:2010(E)
©
ISO 2010
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Requirements.2
4.1 Biological safety.2
4.2 Sterility.3
4.3 Non-pyrogenicity .3
4.4 Mechanical characteristics.3
4.5 Expiry date .5
4.6 Tubing compliance.5
5 Test methods .5
5.1 General .5
5.2 Biological safety.6
5.3 Sterility.6
5.4 Non-pyrogenicity .6
5.5 Mechanical characteristics.6
5.6 Expiry date .9
5.7 Tubing compliance.9
6 Labelling.10
6.1 Labelling on the device.10
6.2 Labelling on the unit container .10
6.3 Labelling on the outer container.10
6.4 Accompanying documentation.11
Bibliography.13
© ISO 2010 – All rights reserved iii
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SIST EN ISO 8638:2014
ISO 8638:2010(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 8638 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 8638:2004), which has been technically
revised.
iv © ISO 2010 – All rights reserved
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
Introduction
This International Standard is concerned with the extracorporeal blood circuit manufactured for single use and
intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements
specified in this International Standard for the extracorporeal blood circuit will help to ensure safety and
satisfactory function.
It was not found practicable to specify materials of construction. This International Standard therefore requires
only that materials have been tested and that the methods and results are made available upon request.
The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser,
haemodiafilter or haemofilter have been specified to ensure compatibility with these devices, as specified in
ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood
and ingress of air. Connectors with either fixed or loose locking shells are permitted.
This International Standard reflects the consensus of physicians, manufacturers and other interested parties
for devices that are approved for clinical use. Conformance with this International Standard is voluntary and it
is not intended to supersede any national regulation.
© ISO 2010 – All rights reserved v
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SIST EN ISO 8638:2014
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SIST EN ISO 8638:2014
INTERNATIONAL STANDARD ISO 8638:2010(E)
Cardiovascular implants and extracorporeal systems —
Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters
1 Scope
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer
protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
This International Standard does not apply to:
⎯ haemodialysers, haemodiafilters or haemofilters;
⎯ plasmafilters;
⎯ haemoperfusion devices;
⎯ vascular access devices;
⎯ blood pumps;
⎯ pressure monitors for the extracorporeal blood circuit;
⎯ air detection devices;
⎯ systems to prepare, maintain or monitor dialysis fluid;
⎯ systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration.
NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in
ISO 8637.
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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 7864, Sterile hypodermic needles for single use
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
© ISO 2010 – All rights reserved 1
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air capture chamber
component intended to capture air and which can provide compliance to the blood circuit or allow pressure to
be monitored
NOTE Air capture chambers are also known as drip chambers, bubble traps or venous and arterial blood chambers.
3.2
extracorporeal blood circuit
blood tubing and integral accessory tubing, including fluid and infusion tubing, for attaching the extracorporeal
blood circuit to pressure monitors and integral components
EXAMPLES (Of integral components.) Air-capture chambers and transducer protectors.
3.3
fluid pathway
internal surfaces of the extracorporeal blood circuit
3.4
labelling
written, printed, graphic or electronic matter that:
⎯ is affixed to a medical device or any of its containers or wrappers
or
⎯ accompanies a medical device and which is related to identification, technical description and use of that
medical device, but excluding shipping documents
3.5
pump segment
portion of the extracorporeal blood circuit (3.2) that is acted upon by the blood pump
3.6
transducer protector
pressure-transmitting sterile barrier
component of the extracorporeal blood circuit (3.2) that is intended to provide an interconnection between the
extracorporeal blood circuit and the haemodialysis machine while allowing the pressure within the
extracorporeal blood circuit to be measured by the machine
4 Requirements
4.1 Biological safety
Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for
freedom from biological hazards, in accordance with 5.2.
2 © ISO 2010 – All rights reserved
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
NOTE Attention is drawn to the need to establish whether national regulations or national standards governing
toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable, in the
countries in which the device is to be marketed.
4.2 Sterility
All fluid contacting surfaces of the device, and the mating surfaces of all connectors integral to the device,
shall be sterile. Compliance shall be verified in accordance with 5.3.
4.3 Non-pyrogenicity
The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance with 5.4.
4.4 Mechanical characteristics
4.4.1 Structural integrity
The device shall be capable of withstanding a positive pressure of 1,5 × the manufacturer's recommended
maximum pressure and a negative pressure not exceeding 700 mmHg (93,3 kPa below atmospheric
pressure) or the highest obtainable negative pressure if at high elevation, when tested in accordance with
5.5.1.
4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter
4.4.2.1 Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood
circuit are designed as an integral system, the dimensions of the connectors for the haemodialyser,
haemodiafilter or haemofilter shall be as given in Figure 1. Compliance shall be verified in accordance
with 5.5.2.
4.4.2.2 Connectors made of semi-rigid materials shall meet the performance requirements of ISO 594-2.
4.4.3 Connectors to vascular access device
Except where the extracorporeal blood circuit and the vascular access device are an integral system, the
dimensions of the connectors intended for connection to vascular access devices shall be a male 6 % (Luer)
taper lock fitting (see ISO 594-2). Connectors made of semi-rigid materials shall meet the performance
requirements of ISO 594-2 taper lock fittings. Compliance shall be verified in accordance with 5.5.3.
4.4.4 Connectors to ancillary components
All parts of the extracorporeal blood circuit intended for use with non-integral ancillary components, such as
heparin lines, pressure-transducer lines, medication-administration lines and level-adjustment lines, shall
terminate in fittings that meet the performance requirements of ISO 594-2 taper lock fittings. Compliance shall
be verified in accordance with 5.5.4.
4.4.5 Colour coding
The arterial patient-connection end shall be colour-coded red, and the venous patient-connection end shall be
colour-coded blue. The coding shall be prominently displayed within 100 mm of the end of the tubing.
Compliance with this requirement shall be verified in accordance with 5.5.5.
© ISO 2010 – All rights reserved 3
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
Dimensions in millimetres
Figure 1 — Main fitting dimensions of extracorporeal blood circuit connector to blood ports of
haemodialyser, haemodiafilter or haemofilter
4.4.6 Access ports
4.4.6.1 Needle access ports
Needle access ports shall not leak when tested in accordance with 5.5.6.1. The access ports shall be
designed so as to minimize the risk of the needle piercing the tube completely and causing injury.
4.4.6.2 Needleless access ports
Needleless access ports shall not leak when tested in accordance with 5.5.6.2.
4.4.7 Blood pathway volume
The range of the blood pathway volume of the extracorporeal blood circuits shall be specified by the
manufacturer. Compliance with this requirement shall be verified in accordance with 5.5.7.
NOTE The blood pathway volume is also known as the priming volume.
4.4.8 Air-capture chamber fill level
The recommended fill level of the air-capture chamber should be marked on the air-capture chamber if that
level is required for proper operation of some monitoring system. Compliance with this requirement shall be
verified in accordance with 5.5.8.
4 © ISO 2010 – All rights reserved
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
4.4.9 Transducer protectors
4.4.9.1 Integral transducer protectors
Extracorporeal blood circuits supplied with integral transducer protectors shall be capable of preventing
cross-contamination. The transducer protector shall be capable of maintaining a secure and leak-free
connection to the haemodialysis machine when subjected to pressures of 1,5 × the manufacturer's
recommended maximum pressure for the device. The machine side of the transducer protector shall be
transparent (clear) to allow for visual inspection of blood contamination during use. Compliance with this
requirement shall be in accordance with 5.5.9.
4.4.9.2 Non-integral transducer protectors
If not supplied as an integral component of the extracorporeal blood circuit, connectors shall be provided to
allow the use of a transducer protector to prevent cross contamination. The transducer protector shall be
capable of maintaining a secure and leak-free connection to the haemodialysis machine when subjected to
pressures of 1,5 × the manufacturer's recommended maximum pressure for the device. The machine side of
the transducer protector shall be transparent (clear) to allow for visual inspection of blood contamination
during use. Compliance with this requirement shall be in accordance with 5.5.9.
4.4.10 Blood pathway flow dynamics
Extracorporeal blood pathways shall be designed to minimize harmful effects to the blood components.
Compliance with this requirement shall be verified in accordance with 5.5.10.
4.4.11 Pump segment performance
The performance characteristics of the pump segment shall be evaluated over the range of inlet pressures
(normally 0 mmHg to −250 mmHg).
Compliance with this requirement shall be verified in accordance with 5.5.11.
4.5 Expiry date
If the expiry date is given, it shall be validated. Accelerated stability studies are acceptable if real time data are
not available. Compliance with this requirement shall be verified in accordance with 5.6.
4.6 Tubing compliance
The blood tubing shall be capable of being occlusively clamped by the venous line clamp of the dialysis
delivery system(s) with which the extracorporeal blood circuit is intended to be used, as indicated in the
labelling for the blood tubing. Compliance with this requirement shall be verified in accordance with 5.7.
5 Test methods
5.1 General
The performance characteristics specified in Clause 4 shall be determined prior to marketing a new type of
device and shall be re-evaluated after changes in the device that might alter its performance.
The sample of devices shall be drawn at random from the manufacturer's production and shall have passed
all applicable quality control steps, as well as sterilization, if applicable. They shall be prepared according to
the manufacturer's recommendations as though they are to be used for a clinical procedure.
© ISO 2010 – All rights reserved 5
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SIST EN ISO 8638:2014
ISO 8638:2010(E)
Measurements shall be made in vitro at (37 ± 1) °C. When the relationship between variables is non-linear,
sufficient determinations shall be made to permit interpolation between the data points. The techniques of
measurement are reference tests. Other test methods may be used, provided it can be shown that they are
validated and of comparable precision and reproducibility.
The test systems shown do not indicate all the necessary details of practicable test apparatus. The design and
construction of actual test systems and their establishment shall also address the many factors contributing to
measurement error, including, but not limited to, pressure measurement errors due to static head effects and
dynamic pressure drops; parameter s
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010)Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8638:2010)Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthotics11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 8638kSIST FprEN ISO 8638:2013en01-september-2013kSIST FprEN ISO 8638:2013SLOVENSKI
STANDARD
kSIST FprEN ISO 8638:2013
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 8638
May 2013 ICS 11.040.40 Will supersede EN 1283:1996English Version
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8638:2010)
Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
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 worldwide for CEN national Members. Ref. No. FprEN ISO 8638:2013: EkSIST FprEN ISO 8638:2013
FprEN ISO 8638:2013 (E) 2 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
kSIST FprEN ISO 8638:2013
FprEN ISO 8638:2013 (E) 3 Foreword The text of ISO 8638:2010 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 8638:2013 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN 1283:1996. 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 8638:2010 has been approved by CEN as FprEN ISO 8638:2013 without any modification.
kSIST FprEN ISO 8638:2013
FprEN ISO 8638:2013 (E) 4 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 (1 of 2) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.1, 4.2, 4.3 7.2
4.1 7.3
4.1, 6.3(q) 7.5 Addressed only in general terms. Although these devices can incorporate materials containing phthalates, there is no specific requirement that the presence of phthalates be indicated in the labelling. 4.4.1, 4.4.9 7.6
4.2, 4.4.1, 4.4.6, 4.4.9, 6.2(e), 6.2(j), 6.4(f), 6.4(i), 6.4(n) 8.1
4.2, 5.3 8.3 Addressed only in general terms. 4.2, 5.3 8.4
4.4.2, 4.4.3, 4.4.4, 4.4.9.2 9.1 Connectors are specified to match tubing connectors specified in ISO 8637 for the blood compartment. 4.4.6.1, 4.4.10, 4.6 9.2
6 13.1
6.1, 6.2, 6.3, 6.4 13.2 The NOTE at the end of each clause allows the use of symbols from Harmonized Standards. 6.2(a), 6.3(a), 6.3(b), 6.4(a) 13.3 (a)
6.2(b), 6.2(c), 6.3(c), 6.3(d), 6.4(b), 6.4(c) 13.3 (b)
kSIST FprEN ISO 8638:2013
FprEN ISO 8638:2013 (E) 5 Table ZA.1 (2 of 2) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2(e), 6.3(f), 6.4(d) 13.3 (c)
6.2(d), 6.3(e) 13.3 (d)
6.2(f), 6.3(g) 13.3 (e)
6.2(g), 6.4(e) 13.3 (f)
6.3(h) 13.3 (i)
6.2(j), 6.4(g), 6.4(i), 6.4(l), 6.4(m), 6.4(o) 13.3 (j)
6.2(j), 6.4(f) 13.3 (k)
6.2(i) 13.3 (m)
6.4(a), 6.4(b), 6.4(c), 6.4(d), 6.4(e), 6.4(f), 6.4(g), 6.4(i), 6.4(l), 6.4(m), 6.4(o) 13.6 (a) There is no requirement for the information in 13.3(i) in the instructions for use. Instead, that information is required to be given on the outer container in which the device is sold. 6.4(r) 13.6 (c)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. kSIST FprEN ISO 8638:2013
kSIST FprEN ISO 8638:2013
Reference numberISO 8638:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO8638Third edition2010-07-01Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters Implants cardiovasculaires et systèmes extracorporels — Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
kSIST FprEN ISO 8638:2013
ISO 8638:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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kSIST FprEN ISO 8638:2013
ISO 8638:2010(E) © ISO 2010 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Requirements.2 4.1 Biological safety.2 4.2 Sterility.3 4.3 Non-pyrogenicity.3 4.4 Mechanical characteristics.3 4.5 Expiry date.5 4.6 Tubing compliance.5 5 Test methods.5 5.1 General.5 5.2 Biological safety.6 5.3 Sterility.6 5.4 Non-pyrogenicity.6 5.5 Mechanical characteristics.6 5.6 Expiry date.9 5.7 Tubing compliance.9 6 Labelling.10 6.1 Labelling on the device.10 6.2 Labelling on the unit container.10 6.3 Labelling on the outer container.10 6.4 Accompanying documentation.11 Bibliography.13
kSIST FprEN ISO 8638:2013
ISO 8638:2010(E) iv © ISO 2010 – All rights reserved 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 8638 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. This third edition cancels and replaces the second edition (ISO 8638:2004), which has been technically revised. kSIST FprEN ISO 8638:2013
ISO 8638:2010(E) © ISO 2010 – All rights reserved v Introduction This International Standard is concerned with the extracorporeal blood circuit manufactured for single use and intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements specified in this International Standard for the extracorporeal blood circuit will help to ensure safety and satisfactory function. It was not found practicable to specify materials of construction. This International Standard therefore requires only that materials have been tested and that the methods and results are made available upon request. The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been specified to ensure compatibility with these devices, as specified in ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood and ingress of air. Connectors with either fixed or loose locking shells are permitted. This International Standard reflects the consensus of physicians, manufacturers and other interested parties for devices that are approved for clinical use. Conformance with this International Standard is voluntary and it is not intended to supersede any national regulation.
kSIST FprEN ISO 8638:2013
kSIST FprEN ISO 8638:2013
INTERNATIONAL STANDARD ISO 8638:2010(E) © ISO 2010 – All rights reserved 1 Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters 1 Scope This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard does not apply to: ⎯ haemodialysers, haemodiafilters or haemofilters; ⎯ plasmafilters; ⎯ haemoperfusion devices; ⎯ vascular access devices; ⎯ blood pumps; ⎯ pressure monitors for the extracorporeal blood circuit; ⎯ air detection devices; ⎯ systems to prepare, maintain or monitor dialysis fluid; ⎯ systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637. 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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings ISO 7864, Sterile hypodermic needles for single use ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood kSIST FprEN ISO 8638:2013
ISO 8638:2010(E) 2 © ISO 2010 – All rights reserved ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 air capture chamber component intended to capture air and which can provide compliance to the blood circuit or allow pressure to be monitored NOTE Air capture chambers are also known as drip chambers, bubble traps or venous and arterial blood chambers. 3.2 extracorporeal blood circuit blood tubing and integral accessory tubing, including fluid and infusion tubing, for attaching the extracorporeal blood circuit to pressure monitors and integral components EXAMPLES (Of integral components.) Air-capture chambers and transducer protectors. 3.3 fluid pathway internal surfaces of the extracorporeal blood circuit 3.4 labelling written, printed, graphic or electronic matter that: ⎯ is affixed to a medical device or any of its containers or wrappers or ⎯ accompanies a medical device and which is related to identification, technical description and use of that medical device, but excluding shipping documents 3.5 pump segment portion of the extracorporeal blood circuit (3.2) that is acted upon by the blood pump 3.6 transducer protector pressure-transmitting sterile barrier component of the extracorporeal blood circuit (3.2) that is intended to provide an interconnection between the extracorporeal blood circuit and the haemodialysis machine while allowing the pressure within the extracorporeal blood circuit to be measured by the machine 4 Requirements 4.1 Biological safety Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for freedom from biological hazards, in accordance with 5.2. kSIST FprEN ISO 8638:2013
ISO 8638:2010(E) © ISO 2010 – All rights reserved 3 NOTE Attention is drawn to the need to establish whether national regulations or national standards governing toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable, in the countries in which the device is to be marketed. 4.2 Sterility All fluid contacting surfaces of the device, and the mating surfaces of all connectors integral to the device, shall be sterile. Compliance shall be verified in accordance with 5.3. 4.3 Non-pyrogenicity The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance with 5.4. 4.4 Mechanical characteristics 4.4.1 Structural integrity The device shall be capable of withstanding a positive pressure of 1,5 × the manufacturer's recommended maximum pressure and a negative pressure not exceeding 700 mmHg (93,3 kPa below atmospheric pressure) or the highest obtainable negative pressure if at high elevation, when tested in accordance with 5.5.1. 4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter 4.4.2.1 Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood circuit are designed as an integral system, the dimensions of the connectors for the haemodialyser, haemodiafilter or haemofilter shall be as given in Figure 1. Compliance shall be verified in accordance with 5.5.2. 4.
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