1、BRITISH STANDARD BSISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters ICS 11.040.20BSISO14972:1998 This British Standard, having been prepared under the directionof the Health and Environment Sector Committee, was published under the authorityof the
2、Standards Committee and comes intoeffecton 15 March1999 BSI 05-1999 ISBN 0 580 32122 3 National foreword This British Standard reproduces verbatim ISO14972:1998 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/27, Medical
3、plastics tubing, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UKinterests informed; monitor related international and European developments
4、 and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue un
5、der the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct
6、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, theISO title page, pagesii toiv, pages1 to3 and a back cover. This standard has been updated (see
7、copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSISO14972:1998 BSI 05-1999 i Contents Page National foreword Inside front cover Foreword iii Text of ISO14972
8、1ii blankBSISO14972:1998 ii BSI05-1999 Contents Page Foreword iii 1 Scope 1 2 Normative references 1 3 Definition 1 4 Requirements 1 Annex A (normative) Method for determining force at break of the obturator 3 Annex B (informative) Bibliography 3 Figure 1 Example of obturator 1 Table 1 Force at brea
9、k 2 Table A.1 Example of conditions for a20mm/min/mm strain rate 3BSISO14972:1998 BSI 05-1999 iii 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 ca
10、rried 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
11、. 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
12、approval by at least75% of the member bodies casting a vote. International Standard ISO14972 was prepared by Technical Committee ISO/TC84, Medical devices for injections, Subcommittee SC1, Syringes, needles and intravascular catheters for single use. Annex A forms a normative part of this Internatio
13、nal Standard. Annex B is for information only.iv blankBSISO14972:1998 BSI 05-1999 1 1 Scope This International Standard specifies requirements for obturators, supplied in the sterile condition and intended for single use for plugging over-needle peripheral catheters. NOTEAttention is drawn to ISO105
14、55-5, which specifies requirements for over-needle peripheral catheters. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All s
15、tandards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
16、ISO594-1:1986, Conical fittings with a6% (Luer) taper for syringes, needles and certain other medical equipment Part1:General requirements. ISO594-2:1998, Conical fittings with a6% (Luer) taper for syringes, needles and certain other medical equipment Par2:Lock fittings. 3 Definition For the purpose
17、s of this International Standard, the following definition applies. 3.1 obturator device designed to be inserted into an over-needle peripheral catheter to plug the lumen of the catheter see Figure 1 4 Requirements 4.1 General The obturator shall have been sterilized by a validated method and it sha
18、ll comply with the requirements given in4.2 to4.10 in the sterile condition. NOTESee ISO11134, ISO11135 and ISO11137 for appropriate methods of sterilization. Figure 1 Example of obturatorBSISO14972:1998 2 BSI 05-1999 4.2 Biocompatibility The obturator shall be free from biological hazard. NOTESee I
19、SO10993-1 for the selection of appropriate test methods. 4.3 Surface When examined by normal or corrected-to-normal vision with2,5 magnification, the external surface of the effective length of the obturator shaft shall appear free from extraneous matter. The external surface and the tip of the obtu
20、rator shaft should be free from surface defects in order to minimize trauma to vessels during use. 4.4 Force at break When tested in accordance with the method given in Annex A, the force at break of the obturator shall be as given in Table 1. 4.5 Luer fitting The Luer fitting shall comply with ISO5
21、94-1 or ISO594-2. 4.6 Outside diameter The outside diameter of the obturator shaft shall be compatible with the inside diameter of the over-needle peripheral catheter(s) with which it is intended to be used in order to plug the lumen of the catheter. 4.7 Effective length When the obturator is fully
22、inserted into the over-needle peripheral catheter, the tip of the obturator shall either coincide with the tip of the catheter or shall extend from the tip of the catheter by no more than3,0mm. 4.8 Colour code The obturator shall be colour-coded with the colour code of the over-needle peripheral cat
23、heter with which it is intended be used. The colour code shall appear on the unit package unless the colour on the product is visible through the unit package. 4.9 Radio-detectability It is recommended that obturators be radio-opaque. At present there is no acceptable, validated test method to deter
24、mine radio-detectability. An approved test method for producing a value of radio-detectability will be established. Until that time, a manufacturer may label the product “radio-opaque” provided this claim can be supported by demonstrating that the manufacturer has an appropriate method for showing r
25、adio-opacity. 4.10 Information to be supplied by the manufacturer The manufacturer shall supply at least the information listed in a) to j). All dimensions given shall be expressed in SI units of measurements. NOTEUnits of other measurement systems may additionally be used. a) Description of the pro
26、duct. b) Suitability for use with a specified over-needle peripheral catheter(s). c) Name or trade name and address of manufacturer. d) Lot designation. e) Expiry date or use by date. f) Any special storage and handling instructions. g) Indication of sterility. h) Method of sterilization. i) Indicat
27、ion for single use. j) Instructions for use and warnings, as appropriate. Table 1 Force at break Smallest outside diameter of obturator shaft mm Minimum force at break N $ 0,350,75 3 $ 0,751,15 5 $ 1,151,85 8 $ 1,85 12BSISO14972:1998 BSI 05-1999 3 Annex A (normative) Method for determining force at
28、break of the obturator A.1 Principle Test pieces of an obturator are chosen so that each obturator portion and each junction between the obturator and the Luer fitting is tested. A tensile force is applied to each test piece until the obturator breaks or the junction separates. A.2 Apparatus A.2.1 T
29、ensile testing apparatus, capable of exerting a force of greater than15N. A.3 Procedure A.3.1 Select a test piece from the obturator to be tested. Include in the test piece the junction between the obturator and the Luer fitting. A.3.2 Condition the test pieces in an atmosphere of100% relative humid
30、ity or water and a temperature of (37 2)C for2h. Test immediately after conditioning. A.3.3 Fix the test piece in the tensile testing apparatus (A.2.1). Use an appropriate fixture to avoid deforming the obturator or the Luer fitting. A.3.4 Measure the gauge length of the test piece (i.e.the distance
31、 between the jaws of the tensile testing apparatus or the distance between the Luer fitting and the jaw holding the other end of the test piece, as appropriate). A.3.5 Apply a tensile strain at unit strain rate of20mm/min per millimetre of gauge length (see Table A.1) until the test piece separates
32、into two or more pieces. Note the value of the applied tensile force, in newtons, at which separation occurs, and record this value as the force at break. A.3.6 Do not perform more than one test on each test piece. Table A.1 Example of conditions for a20mm/min/mm strain rate A.4 Test report The test
33、 report shall include the following information: a) identity of the obturator; b) the force at break, in newtons, and outside diameter of each test piece. Annex B (informative) Bibliography 1 ISO 10555-5:1996, Sterile, single-use intravascular catheters Part5:Over-needle peripheral catheters. 2 ISO
34、10993-1:1997, Biological evaluation of medical devices Part1:Evaluation and testing. 3 ISO 11134:1994, Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization. 4 ISO 11135:1994, Medical devices Validation and routine control of ethyle
35、ne oxide sterilization. 5 ISO 11137:1995, Sterilization of health care products Requirements for validation and routine control Radiation sterilization. Gauge length (mm) Testing speed (mm/min) 10 200 20 400 25 500BSISO 14972:1998 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstituti
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