BS-ISO-14972-1998.pdf
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1、BRITISH STANDARD BS ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters ICS 11.040.20 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 14972:1998 This British Standard, having been prepa
2、red under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 1999 BSI 05-1999 ISBN 0 580 32122 3 National foreword This British Standard reproduces verbatim ISO 14972:1998 and implements it as t
3、he UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/27, Medical 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
4、, or proposals for change, and keep the UK interests informed; monitor related international and European developments 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 implem
5、ent international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purpor
6、t 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 cov
7、er, pages i and ii, the ISO title page, pages ii to iv, pages 1 to 3 and a back cover. This standard has been updated (see 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.Da
8、teComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 14972:1998 BSI 05-1999i Contents Page National forewordInside front cover Forewordiii Text of ISO 149721 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00
9、:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 14972:1998 ii BSI 05-1999 Content
10、s Page Forewordiii 1Scope1 2Normative references1 3Definition1 4Requirements1 Annex A (normative) Method for determining force at break of the obturator3 Annex B (informative) Bibliography3 Figure 1 Example of obturator1 Table 1 Force at break2 Table A.1 Example of conditions for a 20 mm/min/mm stra
11、in rate3 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 14972:1998 BSI 05-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
12、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-government
13、al, 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.
14、 Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 14972 was prepared by Technical Committee ISO/TC 84, Medical devices for injections, Subcommittee SC 1, Syringes, needles and intravascular catheters for singl
15、e use. Annex A forms a normative part of this International Standard. Annex B is for information only. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, U
16、ncontrolled Copy, (c) BSI BS ISO 14972:1998 BSI 05-19991 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 ISO 10555-5, which specifies requ
17、irements 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 standards are subject to re
18、vision, 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. ISO 594-1:1986, Conical fi
19、ttings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements. ISO 594-2:1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Par 2: Lock fittings. 3 Definition For the purposes of this Intern
20、ational 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 shall comply with t
21、he requirements given in 4.2 to 4.10 in the sterile condition. NOTESee ISO 11134, ISO 11135 and ISO 11137 for appropriate methods of sterilization. Figure 1 Example of obturator Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 14972:19
22、98 2 BSI 05-1999 4.2 Biocompatibility The obturator shall be free from biological hazard. NOTESee ISO 10993-1 for the selection of appropriate test methods. 4.3 Surface When examined by normal or corrected-to-normal vision with 2,5 magnification, the external surface of the effective length of the o
23、bturator shaft shall appear free from extraneous matter. The external surface and the tip of the obturator 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
24、 the obturator shall be as given in Table 1. 4.5 Luer fitting The Luer fitting shall comply with ISO 594-1 or ISO 594-2. 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 t
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