INTERNATIONAL
`
`STANDARD
`
`ISO
`
`10555-1
`
`First edition
`1995-06-15
`
`Sterile, single-use intravascular
`catheters -—
`
`Part 1:
`
`General requirements
`
`Catheters intravasculaires stéri/es, non réuti/isables —
`
`Fame 7: Prescriptions géne’ra/es
`
`gm?
`IESO
`=‘W:___::
`
`Reference number
`ISO 10555-1:1995(E)
`
`B. Braun 2022
`
`1
`
`B. Braun 2022
`
`

`

`ISO 10555-1:1995(E)
`
`Contents
`
`Page
`
`1
`
`Scope ..............................................................................................
`
`2 Normative references .....................................................................
`
`3 Definitions .......................................................................................
`
`1
`
`1
`
`1
`
`4 Requirements
`
`............................................................................ 3
`
`5 Designation of nominal size
`
`...................................................... 3
`
`6
`
`Information to be supplied by manufacturer
`
`............................ 3
`
`Annexes
`
`A Test method for corrosion resistance
`
`..................................... 5
`
`B Method for determining force at break
`
`................................... 6
`
`C
`
`D
`
`E
`
`Test method for liquid leakage under pressure
`
`....................... 7
`
`Test method for air leakage into hub assembly during aspiration
`
`8
`
`Bibliography
`
`.............................................................................. 9
`
`© ISO 1995
`All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
`or utilized in any form or by any means, electronic or mechanical including photocopying and
`microfilm, without permission in writing from the publisher,
`International Organization for Standardization
`Case Postale 56 ° CH-1211 Geneve 20 0 Switzerland
`Printed in Switzerland
`
`ii
`
`2
`
`2
`
`

`

`© ISO
`
`ISO 10555-1:1995(E)
`
`Foreword
`
`is a worldwide
`ISO (the International Organization for Standardization)
`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.
`
`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.
`
`International Standard ISO 10555-1 was prepared by Technical Committee
`ISO/IC 84, Medical devices for injections, Subcommittee SC I, Syringes,
`needles and intravascular catheters for single use.
`
`ISO 10555 consists of the following parts, under the general title Sterile,
`single-use intravascu/ar catheters:
`
`— Part 7: General requirements
`
`— Part 2: Angiographic catheters
`
`— Part 3: Central venous catheters
`
`—— Part 4: Balloon dilatation catheters
`
`— Part 5: Over-needle peripheral catheters
`
`Attention is drawn to ISO 11070, which will specify requirements for ac—
`cessory devices for use with intravascular catheters.
`
`Annexes A, B, C and D form an integral part of this part of ISO 10555.
`Annex E is for information only.
`
`'
`
`3
`
`iii
`
`3
`
`

`

`
`
`ISO 10555-1:1995(E)
`INTERNATIONAL STANDARD © ISO
`
`
`Sterile, single-use intravascular catheters —
`
`Part 1:
`
`General requirements
`
`1 Scope
`
`This part of ISO 10555 specifies general requirements
`for
`intravascular catheters,
`supplied in the sterile
`condition and intended for single use, for any appli-
`cation.
`
`It does not apply to intravascular catheter accessories,
`which will be covered by a separate standard.
`
`ISO 7886—1:1993, Sterile hypodermic syringes for sin-
`gle use — Part 1: Syringes for manual use.
`
`3 Definitions
`
`For the purposes of this part of ISO 10555, the fol-
`lowing definitions apply.
`
`intravascular catheter: Tubular device, single
`3.1
`or multilumen, designed to be partially or totally in-
`serted or implanted into the cardiovascular system for
`diagnostic and/or therapeutic purposes.
`
`2 Normative references
`
`3.2 distal end: End of the catheter inserted furthest
`
`The following standards contain provisions which,
`through reference in this text, constitute provisions
`of this part of ISO 10555. At the time of publication,
`the editions indicated were valid. All standards are
`
`subject to revision, and parties to agreements based
`on this part of ISO 10555 are encouraged to investi-
`gate the possibility of applying the most recent edi-
`tions of the standards indicated below. Members of
`
`IEC and ISO maintain registers of currently valid
`International Standards.
`
`ISO 594-1 :1986, Conical fittings with a 6 % (Luer) ta-
`per for syringes, needles and certain other medical
`equipment — Part 7: General requirements.
`
`ISO 594-221991, Conical fittings with a 6 % (Luer) ta-
`per for syringes, needles and certain other medical
`equipment — Part 2: Lock fittings.
`
`into the patient.
`
`3.3 proximal end; access end: End of the catheter
`to which connection can be made.
`
`3.4 hub: Connectoris) at the proximal end of the
`catheter which may either be integral with the
`catheter or be capable of being securely fitted to the
`proximal end of the catheter.
`
`3.5 effective length, 1: Length of the catheter that
`can be inserted into the body. (See figure 1 .)
`
`3.6 outside diameter: Maximum diameter of that
`
`part of the catheter that can be inserted into the
`vessel.
`
`junction: That portion of the catheter that joins
`3.7
`one tube to multiple tubes.
`
`d
`
`4
`
`

`

`ISO 10555-1:1995(E)
`
`© ISO
`
`
`
`
`
`
`
`
`
`Key
`
`1 = effective length
`1.
`catheter hub
`
`2.
`
`3.
`
`4.
`
`catheter strain reinforcement
`
`length mark
`
`junction
`
`Figure 1 — Examples of effective length of catheters
`
`5
`
`

`

`© ISO
`
`ISO 10555-1:1995(E)
`
`Table 1 — Force at break of catheter test pieces
`
`Smallest outside
`diameter of tubular
`
`portion of test piece
`
`mm
`
`Minimum force at break
`
`
`
`4 Requirements
`
`4.1 General
`
`The catheter shall have been sterilized by a validated
`method, and shall comply with 4.2 to 4.7 in the sterile
`condition.
`
`ISO 11135 and ISO 11137 for
`See ISO 11134,
`NOTE1
`appropriate methods of sterilization.
`
`4.2 Biocompatibility
`
`The catheter shall be free from biological hazard.
`
`See ISO 10993-1 for the selection of appropriate
`NOTE 2
`test methods.
`
`4.3 Surface
`
`When examined by normal or corrected to normal
`vision with x 2,5 magnification, the external surface
`of the effective length of the catheter shall appear
`free from extraneous matter.
`
`The external surface of the effective length of the
`catheter, including the distal end, should be free from
`process and surface defects and should cause mini-
`mum trauma to vessels during use.
`
`If the catheter is lubricated, the lubricant should not
`be visible as drops of fluid on the external surface
`when the catheter is examined under normal or cor-
`rected to normal vision.
`
`4.4 Corrosion resistance
`
`When tested in accordance with the method given in
`annex A, metallic components of the catheter shall
`show no signs of corrosion.
`
`4.5 Force at break
`
`When tested in accordance with the method given in
`annex B, the force at break of each test piece shall
`be as given in table 1.
`
`4.6 Freedom from leakage
`
`4.6.1 The hub or connection fitting assembly or any
`other part of the catheter shall not leak liquid when
`tested in accordance with the method given in
`annex C.
`
`NOTE -— This part of ISO 10555 does not specify re-
`quirements for force at break for tubing of less than
`0,55 mm outside diameter.
`
`4.7 Hubs
`
`If the catheter is supplied with either an integral or a
`separate hub, it shall be a female hub and shall com-
`ply with ISO 594-1 and ISO 594—2.
`
`5 Designation of nominal size
`
`The nominal size of the catheter shall be designated
`as specified in 5.1 and 5.2.
`
`5.1 Outside diameter
`
`Unless otherwise specified in the International Stan-
`dard for a particular type of catheter, the outside di-
`ameter shall be expressed in millimetres,
`rounded
`upwards to the nearest 0,05 mm for outside diam-
`eters of less than 2 mm, or to the nearest 0,1 mm for
`outside diameters of 2 mm and greater.
`
`5.2 Effective length
`
`The effective length shall be expressed in a whole
`number of millimetres for effective lengths of less
`than 99 mm and in either a whole number of milli-
`metres or a whole number of centimetres for effec-
`
`tive lengths of 99 mm and greater.
`
`Information to be supplied by
`6
`manufacturer
`
`4.6.2 Air shall not leak into the hub assembly during
`aspiration when tested in accordance with the
`method given in annex D.
`
`The manufacturer shall supply at least the following
`information. All dimensions given shall be expressed
`in SI units of measurement.
`
`6
`
`

`

`ISO 10555-1:1995(E)
`
`© ISO
`
`Units of other measurement systems may additionally
`be used.
`
`g)
`
`any special storage and handling instructions;
`
`a) description of the product;
`
`bl outside diameter;
`
`0)
`
`effective length;
`
`h)
`
`indication of sterility;
`
`i) method of sterilization;
`
`j)
`
`indication for single use;
`
`d) name or tradename and address of manufacturer;
`
`e)
`
`lot designation;
`
`1‘)
`
`expiry date or use by date;
`
`k)
`
`incompati-
`any known chemical and/or physical
`bilities with substances likely to be used with the
`catheter;
`
`l)
`
`instructions for use and warnings, as appropriate.
`
`7
`
`

`

`© I50
`
`I80 10555-1:1995(E)
`
`Annex A
`
`(normative)
`
`Test method for corrosion resistance
`
`A.1 Principle
`
`The catheter is immersed in sodium chloride solution,
`
`then in boiling distilled water, and afterwards exam—
`ined visually for evidence of corrosion.
`
`A.2 Reagents
`
`solution of
`A.2.1 Saline solution, comprising a
`analytical reagent grade sodium chloride in freshly
`prepared distilled water [C(NaCI) = 0,15 mol/I].
`
`A.2.2 Distilled or deionized water.
`
`in boiling
`move the test specimen and immerse it
`distilled water (A22) for 30 min. Allow the water and
`the test specimen to cool to 37 ”C, and maintain them
`at this temperature for 48 h. Remove the test speci-
`men and allow it to dry at room temperature. Disas—
`semble
`specimens
`that
`have
`two
`or more
`components which are intended to be separable in
`use. Do not strip away or cut open any coatings on
`metallic components. Inspect the specimen visually
`for signs of corrosion.
`
`A.3 Apparatus
`
`A.5 Test report
`
`A.3.1 Borosilicate glass beakers.
`
`The test report shall include the following information:
`
`A.4 Procedure
`
`a)
`
`identity of the catheter;
`
`Immerse the catheter in the saline solution (A.2.1) in
`
`b)
`
`a glass beaker (A3) at room temperature for 5 h. Re-
`
`statement as to whether corrosion occurred dur-
`ing the test.
`
`8
`
`

`

`ISO 10555-1:1995(E)
`
`© ISO
`
`Annex B
`
`(normative)
`
`Method for determining force at break
`
`B.1 Principle
`
`Test pieces of a catheter are chosen so that each
`tubular portion, each junction between hub or con-
`nector and tubing, and each junction between tubular
`portions is tested. A tensile force is applied to each
`test piece until the tubing breaks or the junction sep-
`arates.
`
`in
`the applied tensile force,
`Note the value of
`newtons, at which separation occurs, and record this
`value as the force at break.
`
`3.3.6 If testing a catheter that consists of a single
`tubular portion having regions of different outside di—
`ameter, repeat 8.3.2 to 8.3.5 on test pieces of each
`different diameter.
`
`3.2 Apparatus
`
`If testing a catheter that has a sidearm or
`3.3.7
`sidearms,
`
`8.2.1 Tensile testing apparatus, capable of exert-
`ing a force of greater than 15 N.
`
`a)
`
`repeat 8.3.2 to 8.3.5 on each sidearm;
`
`8.3 Procedure
`
`B.3.1 Assemble the catheter in accordance with the
`
`manufacturer's instructions. Select a test piece from
`the catheter to be tested. Include in the test piece the
`hub or connector,
`if present, and the junction be-
`tween segments, eg. between the tubing and the tip,
`if present. Exclude distal
`tips of
`lengths less than
`3 mm from the test piece.
`
`332 Condition the test pieces in an atmosphere
`of 100 % relative humidity or water and a temperature
`of (37 i 2) °C for 2 h. Test
`immediately after con—
`ditioning.
`
`Fix the test piece in the tensile testing ap-
`3.3.3
`If a hub or connector is present, use an ap-
`paratus.
`propriate fixture to avoid deforming the hub or
`connector.
`
`B.3.4 Measure the gauge length of the test piece,
`i.e.
`the distance between the jaws of the tensile
`testing apparatus or the distance between the hub or
`connector and the jaw holding the other end of the
`test piece, as appropriate.
`
`B.3.5 Apply a tensile strain at a unit strain rate of
`20 mm/min/mm of gauge length (see table 8.1) until
`the test piece separates into two or more pieces.
`
`b)
`
`repeat 8.3.2 to 8.3.5 on a test piece that includes
`the joint between a sidearm and the adjacent part
`of that portion of the catheter intended to be in-
`troduced into the body;
`
`c)
`
`repeat 83.7 b) for each joint.
`
`3.3.8 Do not perform more than one test on any
`test piece.
`
`Table 3.1 -— Examples of conditions for
`20 mm/min/mm strain rate
`
`Gauge length
`
`Test speed
`
`mm
`
`mm/min
`
`
`
`3.4 Test report
`
`The test report shall include the following information:
`
`a)
`
`identity of the catheter;
`
`b)
`
`the force at break, in newtons, and outside diam—
`eter of each test piece.
`
`9
`
`

`

`© ISO
`
`ISO 10555-1 :1 995(El
`
`Annex C
`(normative)
`
`Test method for liquid leakage under pressure
`
`0.1 Principle
`
`The catheter is connected, via a leakproof connection,
`to a syringe. A hydraulic pressure is applied to the
`catheter and to the hub assembly, if present, and the
`catheter tube inspected for leakage.
`
`the hub to the reference fitting (0.3.1) by
`nect
`applying an axial force of 27,5 N for 5 5 while applying
`a twisting action to a value of torque not exceeding
`0,1 N-m to give rotation not exceeding 90°, both
`components being dry. Connect the reference fitting
`(0.3.1) via
`the connector
`(0.3.2)
`to the syringe
`(0.3.4).
`
`0.2 Reagent
`
`0.2.1 Distilled or deionized water.
`
`0.3 Apparatus
`
`0.3.1 Reference steel fitting, having a male 6 %
`(Luer) taper as specified in ISO 594—1.
`
`to connect reference
`0.3.2 Leakproof connector,
`fitting (0.3.1) to syringe (0.3.4), fitted with a gauge
`capable of measuring up to 350 kPa pressure and
`having a small internal volume.
`
`0.3.3 Connector, to make leakproof connection be-
`tween syringe (0.3.4) and catheters which do not
`have hubs.
`
`0.3.4 10 ml syringe, which has passed the tests for
`leakage past the piston and nozzle as specified in
`ISO 7886-1.
`
`0.4.2 When testing catheters which do not have
`hubs, connect the catheter to the syringe (0.3.4) by
`means of a connector (0.3.3).
`
`at
`(0.2)
`syringe with water
`the
`0.4.3 Fill
`(22 i 2) °C and expel the air. Adjust the volume of
`water in the syringe to the nominal graduated ca-
`pacity. Occlude (0.3.5) the test specimen as near the
`distal end as possible.
`
`0.4.4 Position the apparatus so that the axis of the
`connection between syringe and catheter is horizon-
`tal. Apply an axial force to the syringe so that a
`pressure of 300 kPa to 320 kPa is generated by the
`relative action of the piston and barrel. Maintain the
`pressure for 30 3. Examine the hub assembly,
`if
`present, and catheter tube for liquid leakage, i.e. the
`formation of one or more falling drops of water, and
`record whether or not leakage occurs.
`
`0.3.5 Means for occluding test specimen, eg. a
`clamp.
`
`0.5 Test report
`
`0.4 Procedure
`
`The test report shall include the following information:
`
`0.4.1 When testing catheters which have a hub or
`hubs,
`if necessary assemble detachable hubs in ac-
`cordance with the manufacturer's instructions. Con—
`
`a)
`
`identity of the catheter;
`
`b)
`
`statement as to whether leakage occurred from
`the hub assembly, if present, or catheter tube.
`
`10
`
`10
`
`

`

`ISO 10555-1z1995iE)
`
`© ISO
`
`Annex D
`
`(normative)
`
`Test method for air leakage into hub assembly during aspiration
`
`D.1 Principle
`
`The hubls) of the catheter is (are) connected via a
`reference male conical
`fitting,
`to a partially filled
`syringe. A reduced pressure is applied to the interface
`of the hub and the reference fitting by withdrawing
`the syringe plunger, and visual inspection made for
`the ingress of air bubbles to the syringe.
`
`D.2 Reagent
`
`D.2.1 De-aerated distilled water or de-aerated
`deionized water.
`
`D.3 Apparatus
`
`D.3.1 Reference steel fitting, as specified in (3.3.1.
`
`D.3.2 Leakproof connector, as specified in C.3.2,
`but without tapping and pressure gauge.
`
`D.3.3 Syringe, as specified in C.3.4.
`
`D.3.4 Means for occluding test specimen, e.g. a
`clamp.
`
`0,1 N-m to give rotation not exceeding 90°, both
`components being dry.
`
`D.4.2 Connect the reference fitting (D.3.1) via the
`connector (D.3.2) to the syringe (D.3.3). Seal all valves
`that are intended to open during aspiration.
`
`through the test
`D.4.3 Draw into the syringe,
`specimen and reference fitting, a volume of water
`(D.2) at (22 i 2) °C exceeding 25 % of the graduated
`capacity
`of
`the
`syringe. Avoid wetting
`the
`hub/reference fitting union.
`
`D.4.4 Expel the air from the apparatus except for a
`small air bubble. Adjust the volume of the water in the
`syringe to 25 % of the graduated capacity. Occlude
`(D.3.4) the test specimen as close as practicable to
`the hub.
`
`D.4.5 With the nozzle of the syringe downward,
`withdraw the plunger to the maximum graduated ca-
`pacity mark. Hold for 15 s and examine the water in
`the syringe for the formation of air bubbles,
`ignoring
`bubbles formed during the first 5 3.
`
`D.4 Procedure
`
`D5 Test report
`
`in accordance
`D.4.1 Assemble detachable hubs
`with the manufacturer's instructions. Connect the hub
`
`to be tested to the reference fitting (D.3.1) by applying
`an axial force of 27,5 N for 53 while applying a
`twisting action to a value of torque not exceeding
`
`The test report shall include the following information:
`
`a)
`
`identity of the catheter;
`
`b)
`
`statement as to whether leakage of air occurred
`from the hub assembly after the first 5 s.
`
`11
`
`11
`
`

`

`© ISO
`
`ISO 10555-1:1995(E)
`
`Annex E
`
`(informative)
`
`Bibliography
`
`of
`evaluation
`Biological
`[1] ISO 1099311992,
`medical devices — Part 1: Guidance on selec-
`tion of tests.
`
`[3] ISO 11135:1994, Medical devices — Validation
`and
`routine
`control
`of
`ethylene
`oxide
`sterilization.
`
`[2] ISO 11134:1994, Sterilization of health care
`products — Requirements for validation and
`routine
`control — Industrial moist heat
`sterilization.
`
`[4] ISO 11137:1995, Sterilization of health care
`products — Requirements for validation and
`routine control — Radiation sterilization.
`
`12
`
`12
`
`

`

`ISO 10555-1:1995(E)
`
`© ISO
`
`
`
`ICS 11.040.20
`
`sterile equipment, disposable equipment, vascular system, catheters,
`Descriptors: medical equipment,
`designation, consumer information.
`Price based on 9 pages
`
`specifications,
`
`tests,
`
`13
`
`13
`
`