BS EN ISO 10555-2-1997 Sterile single-use intravascular catheters Angiographic catheters《一次性无菌血管内导管 血管造影用导管》.pdf

1、BRITISH STANDARD BS EN ISO 10555-2:1997 Incorporating Technical Corrigendum No. 1 Sterile, single-use intravascular catheters Part 2: Angiographic catheters The European Standard EN ISO 10555-2:1997 has the status of a British Standard ICS 11.040.20 BS EN ISO 10555-2:1997 This British Standard, havi

2、ng 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 September 1997 BSI 7 January 2003 ISBN 0 580 28045 4 National foreword This British Standard is the English language version of EN ISO

3、 10555-2:1997, including Corrigendum July 2002. It is identical with ISO 10555-2:1996, including Technical Corrigendum June 2002. It supersedes BS 7174-2:1990 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/27, Medical plastics tubing, which has th

4、e 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 UK interests informed; monitor related international and European developments and promulgate them in the

5、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 Catalogue under the section entitled “Internationa

6、l Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British S

7、tandard 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 ISO title page, the EN ISO foreword page, the ISO title page, the ISO foreword page, pages 1 to 5 and a back cover. The BSI copyrig

8、ht notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14058 Corrigendum No. 1 7 January 2003 Deletion of note in 4.2 and renumbering of notes given in 4.5BS EN ISO 10555-2:1997 BSI 7 January 2003 i Contents Page N

9、ational foreword Inside front cover Text of ISO 10555-2 1ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-2 July 1997 ICS 11.040.20 Incorporating corrigendum July 2002 Descriptors: See ISO document English version Sterile, single-use intravascular catheters Part 2: Angiographic

10、 catheters (ISO 10555-2:1996) Cathters intravasculaires striles, non rutilisables Partie 2: Cathters angiographiques (ISO 10555-2:1996) Sterile intravaskulre Katheter zur einmaligen Verwendung Teil 2: Angiographiekatheter (ISO 10555-2:1996) This European Standard was approved by CEN on 1997-06-09. C

11、EN 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 ap

12、plication to the Central Secretariat or to any CEN member. The European Standards exist 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

13、 the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Com

14、mittee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-2:1997 EEN ISO 10555-2

15、:1997 BSI 7 January 2003 Foreword The text of the International Standard from Technical Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization (ISO) has been taken over as a European Standard by Technical Committee CEN/TC 205 “Non-active medical de

16、vices”, 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 January 1998, and conflicting national standards shall be withdrawn at the latest by January 1998.

17、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, Por

18、tugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10555-2:1996 has been approved by CEN as a European Standard without any modification. NOTE Normative references to International Standards are listed in Annex ZA (normative). Endo

19、rsement notice The text of ISO 10555-2:1997/Corr. 1:2002 has been approved by CEN as a European Corrigendum without any modifications. Incorporating Technical Corrigendum2002-06-15EN ISO 10555-2:1997 BSI 7 January 2003 Foreword ISO (the International Organization for Standardization) is a worldwide

20、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 c

21、ommittee. 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 th

22、e 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 10555-2 was prepared by Technical Committee ISO/TC 84, Medical devices for injections, Su

23、bcommittee SC 1, Syringes, needles and intravascular catheters for single use. ISO 10555 consists of the following parts, under the general title Sterile, single-use intravascular catheters: Part 1: General requirements; Part 2: Angiographic catheters; Part 3: Central venous catheters; Part 4: Ballo

24、on dilatation catheters; Part 5: Over-needle peripheral catheters. Annex A forms an integral part of this part of ISO 10555. Annex B is for information only. Descriptors: Medical equipment, sterile equipment, disposable equipment, vascular system, catheters, specifications, tests, designation, consu

25、mer information.EN ISO 10555-2:1997 BSI 7 January 2003 1 1 Scope This part of ISO 10555 specifies requirements for angiographic catheters supplied in the sterile condition, and intended for single use. NOTE 1 Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use

26、 with intravascular catheters. 2 Normative reference 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 edition indicated were valid. All standards are subject to revision, and parties to

27、agreements based on this part of ISO 10555 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 10555-1:1995, Sterile, single-use intravascular ca

28、theters Part 1: General requirements. 3 Definitions For the purposes of this part of ISO 10555, the definitions given in ISO 10555-1 and the following definitions apply. 3.1 angiographic catheter intravascular catheter used for the injection or infusion of contrast media and/or fluids and which may

29、be used for pressure measurements and to obtain blood samples 3.2 distal end configuration shape of the catheter which is designed to facilitate its manual manipulation through the cardiovascular system and the placement of the tip in the location chosen for the angiographic procedures 4 Requirement

30、s 4.1 General Unless otherwise specified in this part of ISO 10555, catheters shall comply with ISO 10555-1. 4.2 Radio-detectability The catheter shall be radio-detectable. 4.3 Designation of nominal size The nominal size of the catheter shall be designated in accordance with ISO 10555-1 and also by

31、 the diameter of the largest guidewire that can be used with the catheter. If the inside diameter of the catheter is additionally designated, it shall be expressed in millimetres, rounded down to the nearest 0,1 mm. 4.4 Physical requirements 4.4.1 Tip configuration In order to minimize trauma to ves

32、sels during use, the tip of the distal end should be smooth, rounded, tapered or similarly finished. 4.4.2 Freedom from leakage and damage under high static pressure conditions When tested as described in Annex A, there shall be no liquid leakage from the catheter and no visible signs of damage. The

33、re shall be no permanent deformation of the catheter shaft sufficient to prevent the free movement of a ring gauge over the tested portion of the catheter.EN ISO 10555-2:1997 2 BSI 7 January 2003 4.4.3 Side holes The design, number and positioning of side holes should be such as to minimize adverse

34、effects on the catheter and trauma to the tissues. 4.5 Information to be supplied by the manufacturer Information supplied by the manufacturer shall comply with ISO 10555-1 and shall also include the following: a) nominal size of the catheter, as designated in 4.3; b) depiction or description of the

35、 distal end configuration, if not identifiable through the package; c) maximum rated injection pressure, expressed in kilopascals (kPa), as determined under dynamic test conditions. NOTE 2 The time for which the catheter can withstand the maximum rated pressure may also be given. NOTE 3 Units of mea

36、surement systems other than those specified in this part of ISO 10555 may additionally be used.EN ISO 10555-2:1997 BSI 7 January 2003 3 Annex A (normative) Test for freedom from leakage and damage under high static pressure conditions A.1 Principle The catheter is connected via its hub or proximal e

37、nd to a source of hydraulic pressure. Pressure is applied for a fixed time, and the specimen examined for rupture and leakage under pressure, and for evidence of leakage, damage or distortion after the pressure is removed. A.2 Apparatus A.2.1 Hydraulic pressure-generating device, which uses only liq

38、uid as a pressurizing fluid and maintains its temperature at (37 2) C. A.2.2 Leak-proof connector A.2.3 Locking device, for securing the catheter to the connector (A.2.2). A.2.4 Means of occluding the catheter, for example a clamp. A.2.5 Ring gauges for each size of catheter, each having an inside d

39、iameter 10 % greater than the nominal outside diameter of the catheter shaft. NOTE 5 The general arrangement of the apparatus is shown in Figure A.1. The apparatus for generating and controlling the pressure is not shown in detail, as it may vary in design, complexity and degree of automation. A.3 T

40、est procedure WARNING It is essential that precautions and safeguards be taken to protect the test operator from the consequences of failure of the pressurized system and the resulting escape of liquid under high pressure. A.3.1 Start the filtration system (see Figure A.1), if fitted. A.3.2 Bring th

41、e pressurized liquid and the catheter to a temperature of (37 2) C, and maintain this temperature throughout the test. A.3.3 Attach the free end of the hub of the catheter to the connector (A.2.2), securing it with the locking device (A.2.3). A.3.4 Ensure the air is displaced from the catheter by th

42、e liquid, then occlude the catheter at a distance of approximately one-half its effective length from the catheter hub, using the clamp (A.2.4). A.3.5 Check the hydraulic circuit for integrity and freedom from leaks. A.3.6 Adjust the pressure-generating device (A.2.1) so that it will apply the maxim

43、um rated pressure stated by the manufacturer of the catheter under test for a time of 2 s or the maximum time stated by the manufacturer of the catheter under test, whichever is longer. A.3.7 Apply the selected pressure for the selected time. A.3.8 While the pressure is being applied, inspect the ca

44、theter for rupture and leakage (i.e. formation of one or more falling drops of liquid). After the pressure has been removed, disconnect the catheter from the test apparatus and examine it for damage, rupture or evidence of leakage. Attempt to pass the ring gauge freely along the test portion of the

45、catheter shaft. A.4 Test report The test report shall include the following information: a) identity of the catheter; b) rated pressure and pressurization time used; c) whether leakage occurred from the test portion of the catheter; d) whether the test portion of the catheter was damaged or ruptured

46、; e) whether the ring gauge could be passed freely along the tested portion of the catheter shaft.EN ISO 10555-2:1997 4 BSI 7 January 2003 Key 1 Hydraulic pressure generator and control system (A.2.1) 2 Connector (A.2.2) 3 Locking device (A.2.3) 4C l a m p o r p l u g ( A.2.4) 5 Catheter under test

47、6 Example of test chamber 7 Spent liquid return (optional) 8 Reservoir for pressurizing liquid 9 Filtration system (optional) Figure A.1 General arrangement of test apparatus for assessing freedom from leakage and damage under high static pressure conditionsEN ISO 10555-2:1997 BSI 7 January 2003 5 A

48、nnex B (informative) Bibliography 1 ISO 11070:, Sterile, single-use intravascular catheter introducers 1) . Annex ZA (normative) Normative references to international publications with their relevant European publications This European Standard incorporates by dated or undated reference, provisions

49、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. 1) To be published. Publication Year Title EN Year IS