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1616 : 1997
Incorporating Amendment No 1
The European Standard EN 1616:1997, including its amendment A1:1999, has
the status of a British Standard
ICS 11.040.20
NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
Sterile urethral
catheters for single use
Trang 2BS EN 1616 : 1997
This British Standard, having
been prepared under the
direction of the Health and
Environment Sector Board, was
published under the authority of
the Standards Board and comes
into effect on
15 July 1997
BSI 08-1999
The following BSI references
relate to the work on this
standard:
Committee reference CH/1
Draft for comment 94/506464 DC
Amendments issued since publication
Committees responsible for this British Standard
The preparation of this British Standard was entrusted to Technical Committee CH/1, Catheters, upon which the following bodies were represented:
Association of British Health-care Industries Association of Continence Advisors
British Association of Urological Surgeons British Rubber Manufacturers' Association Ltd
Medical Sterile Products Association
Trang 3BS EN 1616 : 1997
Contents
Page
Annexes
Tables
C.1 Requirements for load test 10
D.1 Balloon test capacities 11
D.2 Balloon test volume percentage recovery 11
Figures
A.1 Apparatus and general arrangement for testing catheters' strength 7
B.1 Test connector and general arrangement for testing security of fit of the
Trang 4BS EN 1616 : 1997
National foreword
This British Standard has been prepared by Technical Committee CH/1 and is the
English language version of EN 1616 : 1997 Sterile urethral catheters for single use,
published by the European Committee for Standardization (CEN)
It supersedes BS 1695 : Part 1 : 1990 and Part 2 : 1990, which are withdrawn
Cross-references
Publication referred to Corresponding British Standard
Requirements for terminally-sterilized devices to be labelled
`Sterile'
of medical devices
catheters Ð Test methods for common properties
for syringes, needles and certain other medical equipment Ð
Part 1: General requirements
The Technical Committee has reviewed the provisions of prEN 1041, to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this British Standard
A British Standard does not purport to include all the necessary provisions of a contract Users of British Standards are responsible for their correct application
Compliance with a British Standard does not of itself confer immunity from legal obligations.
Summary of pages
This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 12, an inside back cover and a back cover
The BSI copyright notice displayed throughout this document indicates when the document was last issued
Sidelining in this document indicates the most recent changes by amendment
Trang 5CEN
European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr Normung
Central Secretariat: rue de Stassart 36, B-1050 Brussels
Members
Ref No EN 1616 : 1997/A1 : 1999 E
March 1999
+ A1
December 1998
ICS 11.040.20
Descriptors: medical equipment, disposable equipment, urinary tract catheters, specifications, dimensions, flow rates, tensile strength,
junctions, safety, labelling
English version
Sterile urethral catheters for single use
(includes amendment A1:1999)
Sondes urinaires steÂriles non reÂutilisables
(inclut l'amendement A1:1999)
Sterile Harnblasenkatheter zur einmaligen Verwendung
(enthaÈlt AÈnderung A1:1999)
This amendment A1 modifies the European Standard EN 1616 : 1997; it was approved
by CEN on 13 February 1999
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amenment into the relevant national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member
This amendment 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 Central Secretariat has the same status as the official versions
CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom
Trang 6Page 2
EN 1616 : 1997
Foreword
This European Standard has been prepared by
Technical Committee CEN/TC 205, Non-active medical
devices, the secretariat of which is held by BSI
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 1997,
and conflicting national standards shall be withdrawn
at the latest by August 1997
According to the CEN/CENELEC Internal Regulations,
the national standards organizations of the following
countries are bound to implement this European
Standard: Austria, Belgium, Denmark, Finland, France,
Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom
Annexes A, B, C and D form normative parts of this
European Standard Annex E is for information
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Foreword to EN 1616 : 1997/A1 : 1999
This Amendment EN 1616 : 1997/A1 : 1999 to
EN 1616 : 1997 has been prepared by Technical Committee CEN TC 205, Non-active medical devices, the Secretariat of which is held by BSI
This Amendment to the European Standard
EN 1616 : 1997 shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by September 1999, and conflicting national standards shall be withdrawn at the latest by September 1999
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom
Trang 7Page 3
EN 1616 : 1997
BSI 08-1999
1 Scope
This European Standard specifies requirements for
sterile, single-use urethral catheters, with and without
balloons
2 Normative references
This European Standard incorporates by dated or
undated reference, provisions from other publications
These normative references are cited at the
appropriate places in the text and the publications are
listed hereafter For dated references, subsequent
amendments to or revisions of any of these
publications apply to this European Standard only
when incorporated in it by amendment or revision For
undated references the latest edition of the publication
referred to applies
Requirements for medical devices
to be labelled `Sterile'
manufacturer for medical devices
Ð Graphical symbols for medical devices
information provided with medical devices Ð Information provided with medical devices supplied by the manufacturer
catheters Ð Test methods for common properties
taper for syringes, needles and certain other medical equipment
Ð Part 1: General requirements
(ISO 594-1 : 1986)
3 Definitions
For the purposes of this European standard, the
following definitions apply
3.1 urethral catheter
Tubular device intended for being introduced into the vesical cavity through the urethra in order to provide drainage and/or flushing of the bladder
3.2 balloon capacity
Volume of liquid to be introduced into the catheter in order to fill the inflation channel and inflate the balloon
3.3 shaft
Portion of the catheter excluding the tip, balloon(s), funnel(s) and/or sideport
3.4 outside diameter
Maximum dimension measured across the cylindrical portion of the shaft
4 Requirements
4.1 General
All tests shall be carried out on the product in the ready-for-use state
4.2 Surface finish
When the catheter is ready for use (e.g treated according to the manufacturer's instructions) and is examined by normal or corrected-to-normal vision
at 2,5 times magnification, the surface of the shaft, tip, balloon and eyes shall appear free from extraneous matter
4.3 Dimensions
4.3.1 Size designation
The size of the catheter shall be designated by its nominal outside diameter expressed in mm to the nearest 0,1 mm Tolerances on this stated size shall be
in ml
NOTE Additional units can also be given.
4.3.2 Lengths
The minimum overall length (L) and shaft lengths (S)
shall be as given in table 1 (see also figure 1)
Trang 8Page 4
EN 1616 : 1997
1 Drainage funnel
2 Inflation funnel
3 Valve
4 Irrigation funnel
L is the overall length
S is the effective length
Figure 1 Typical urethral catheters a) without and b) with balloon
Trang 9Page 5
EN 1616 : 1997
BSI 08-1999
Table 2 Average flow rates
Designated size Average flow rate (minimum)
Outside diameter CharrieÁre equivalent1) Drainage lumen Irrigation lumen
1) The CharrieÁre equivalent is given for information.
2) n.a = not applicable.
Table 1 Shaft dimensions
Catheter type L (minimum)
mm
S (minimum)
mm
Paediatric without
balloon
Paediatric with
balloon
Female without
balloon
Male without
balloon
1) n.a = not applicable.
4.4 Strength
When tested in accordance with the method given in
annex A, neither the tip nor the funnel shall become
detached from the shaft, and the shaft shall not show
any sign of breaking
4.5 Connector security
When tested in accordance with the method given in
annex B, the drainage funnel shall not part from the
test connector
4.6 Balloon security
4.6.1 When tested in accordance with the method
given in annex C, the balloon shall not leak and shall
not occlude the drainage eyes
NOTE The change in profile at each end of the uninflated balloon
should be smoothly blended with the shaft The balloon should be
capable of approximately symmetrical expansion when filled with
water at ambient temperature to its specified balloon capacity.
4.6.2 When tested by the method given in annex D,
the percentage of water recovered shall be not lower than the value given in table D.2
4.7 Kinkability
NOTE This subclause will be prepared when a test method has been developed.
4.8 Flow rates
When tested in accordance with the method given in annex E of EN 1618 : 1997, the minimum flow rates shall be as given in table 2
4.9 Biocompatibility
The device shall be evaluated for biocompatibility and shall be free from biological hazard
NOTE Methods for evaluation for biocompatibility are given in
EN 30993.
4.10 Sterility
The device shall comply with EN 556
4.11 Corrosion test
When tested in accordance with the method given in annex A of EN 1618 : 1997, the test specimen shall not show any evidence of corrosion
5 Symbols and labelling
The symbols and information provided with catheters shall be as specified in EN 980 and prEN 1041, and in addition the following information shall be given:
a) the manufacturer's stated minimum and maximum balloon inflation volumes;
b) the designated size as given in 4.3.1.
Trang 10Page 6
EN 1616 : 1997
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Annex A (normative)
Test method for determining the strength
of the catheter
A.1 Principle
Catheters fitted with balloons may be in situ for
prolonged periods Such catheters are therefore
immersed for 14 days in simulated urine prior to
testing This step is omitted for catheters without
balloons A tensile force is applied to the union of the
tip and shaft of the catheter For catheters with lateral
eyes, the tensile force is to be applied to the eyes For
catheters with no lateral eyes, the tensile force is
applied between the shaft of the catheter and the
drainage funnel On removal of this force, the catheter
is examined for signs of failure
A.2 Reagents
A.2.1 Simulated urine, pH approximately 6,6, of the
following composition, the reagents being of
recognized analytical grade:
Disodium hydrogen orthophosphate,
WARNING This solution can support microbial
growth There is a strong possibility that large numbers
of microorganisms will be present in the solution at
the end of the tests described in A.3 and C.3 These
procedures should be carried out by trained personnel
taking appropriate precautions in the handling of the
immersed catheter and the disposal of the
contaminated solution
A.3 Apparatus
A.3.1 Device for suspending catheter with lateral
eyes, comprising a pin which passes through a
drainage eye of the catheter, the pin having a diameter
of between 50 % and 75 % of that of the drainage lumen
of the catheter to be tested An example of a suitable device is shown in figure A.1a)
For catheter without lateral eyes, the shaft of the catheter is suspended in a suitable clamp
A.3.2 Device for attaching a weight to the drainage
funnel and a weight, their combined mass being 1 kg
for catheters of outside diameter greater than 3,3 mm and 0,75 kg for catheters up to gauge size 3,3 mm
A.3.3 Water bath or other device, capable of being
A.3.4 Stopwatch.
A.4 Procedure
Immerse the catheter in the freshly prepared simulated
urine (A.2.1) in the water bath (A.3.3), controlled at
completely submerged
Allow the catheter to remain in the simulated urine for 14 days and then remove the catheter, rinse it with tap water and dry it Allow the catheter to come to a
Suspend the catheter from the suspension device
(A.3.1) by passing the pin into the drainage eye
nearest the tip of the catheter (see figure A.1)
For catheters without lateral eyes, use a suitable clamp
Manually support the weight (A.3.2) Attach the
weight to the drainage funnel of the catheter Gently lower the weight until it is freely suspended from the catheter Allow it to remain in this position for 1 min
Remove the weight and visually examine all unions of the catheter for detachment or failure of bonds and any eyes for signs of splitting
A.5 Test report
The test report shall contain the following information:
a) the identity of the catheter;
b) the condition of the tip/shaft union and eyes after testing
Trang 11Page 7
EN 1616 : 1997
BSI 08-1999
NOTE 1 Dimension D is between 50 %
and 75 % of the diameter of the catheter lumen.
a) Example of support frame and pin.
NOTE 2 Dimension P is sufficient to allow
the tip of the pin to engage the tip of the catheter and not permit the supporting member to engage the rim of the eye when the catheter is loaded.
b) Pin introduced through eye of catheter.
1 Inflation funnel
2 Drainage funnel
3 Valve
4 Direction of test force c) Arrangement for testing.
Figure A.1 Apparatus and general arrangement for testing catheters' strength
Trang 12Page 8
EN 1616 : 1997
Annex B (normative)
Test method for determining the security
of fit of the drainage funnel
B.1 Principle
A specified test connector is fitted to the drainage
funnel of the catheter, and an axial extensional force is
applied to test the security of the connection
B.2 Apparatus
B.2.1 Test connector, of rigid material, having the
dimensions shown in figure B.1a)
B.2.2 Clamp or similar device, for suspending the
catheter
B.2.3 Device for attaching a weight to the test
connector and a weight, the combined mass of
connector, device and weight being 0,75 kg for testing
catheters up to size 3,3 mm and 1 kg for testing all
other outside diameters
B.2.4 Stopwatch.
B.3 Procedure
Ensure that the drainage funnel of the catheter and the
test connector (B.2.1) are clean and dry.
Fit the test connector into the drainage funnel to a depth of engagement of, or exceeding, 10 mm (i.e up
to, or beyond, the mark on the connector)
Suspend the catheter by clamping (B.2.2) it at a point
near the junction of the funnels and the shaft (see figure B.1b))
Manually support the weight (B.2.3) Attach the weight
to the test connector and gently lower the weight until
it is freely suspended from the connector Allow it to remain in this position for 1 min and observe
Record whether the test connector parts from the drainage funnel
B.4 Test report
The test report shall contain the following information: a) the identity of the catheter;
b) whether the test connector remained in the funnel during the test