1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12439:1999 The Euro
2、pean Standard EN 12439:1998 has the status of a British Standard ICS 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Sterile rectal catheters for single useThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee,
3、 was published under the authority of the Standards Committee and comes into effect on 15 April 1999 BSI 04-1999 ISBN 0 580 30685 2 BS EN 12439:1999 Amendments issued since publication Amd. No. Date Text affected National foreword This British Standard is the English language version of EN 12439:199
4、8. 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 European committee any enquiries on the interpretation, or proposals for change, and keep
5、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 implement international or European public
6、ations 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 purport to include all the necessary provi
7、sions 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, the EN title page, pages 2 to 4,
8、 an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN
9、national Members. Ref. No. EN 12439:1998 E EUROPEAN STANDARD EN 12439 NORME EUROPE ENNE EUROPA ISCHE NORM October 1998 ICS 11.040.20 Descriptors: medical equipment, rectal catheters, disposable equipment, definitions, specifications, dimensions, designation, tensile strength, gas permeability, label
10、ling, packing, storage English version Sterile rectal catheters for single use Sondes rectales ste riles non re utilisables Sterile Rektalkatheter zur einmaligen Verwendung This European Standard was approved by CEN on 2 October 1998. CEN members are bound to comply with the CEN/CENELEC Internal Reg
11、ulations 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 application to the Central Secretariat or to any CEN member. This
12、European Standard 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
13、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.Page 2 EN 12439:1998 BSI 04-1999 Foreword This European Standard has been prepar
14、ed 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 April 1999, and conflicting national stan
15、dards shall be withdrawn at the latest by April 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
16、, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. The document is based on DIN 13273-4, Catheters for medical use Part 4: Single-use rectal catheters. Annex A is given for information only. Contents Page Foreword 2 1 Scope 3 2 Normative r
17、eferences 3 3 Definitions 3 4 Requirements 3 5 Labelling 4 Annex A (informative) Bibliography 4Page 3 EN 12439:1998 BSI 04-1999 l d = effective length = outer diameter 1 Closed, rounded tip Figure 1 Designation of dimensions 1 Scope This European Standard specifies requirements for single-use rectal
18、 catheters intended to be inserted into the rectum of a patient, for emptying, rinsing or filling purposes. 2 Normative references This European Standard incorporates by dated or undated reference provisions from other publications. The normative references are cited at the appropriate places in the
19、 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
20、applies. EN 556:1994 + A1:1998, Sterilization of medical devices Requirements for terminally-sterilized medical devices to be labelled “Sterile”. EN 1041, Information supplied by the manufacturer with medical devices. EN 1618, Catheters other than intravascular catheters Test methods for common prop
21、erties. 3 Definitions For the purposes of this European Standard, the following definitions apply. 3.1 rectal catheter medical device consisting of a catheter tube, which can be fitted with a connector with tapered bore, intended to be inserted into the rectum of a patient 3.2 collapse flattening of
22、 the shaft, obstructing the flow through the catheter 4 Requirements 4.1 General The tests to ascertain that requirements are fulfilled shall be performed on the product in the ready-for-use state. 4.2 Dimensions and designation Rectal catheter dimensions should be defined as designated in Figure 1.
23、 The area of any eye shall not exceed the cross-sectional area of the lumen, and the tip shall be rounded and closed. NOTE The design of the catheter in Figure 1 is an example and is given for information only. The size and position of the catheter eyes should not compromise the stiffness required f
24、or catheter insertion. 4.3 Biocompatibility The catheter shall be evaluated for biocompatibility, and shall be free from biological hazard. NOTE Methods for evaluation for biocompatibility are given in EN 30993. 4.4 Kink stability NOTE This clause will be prepared when a test method has been develop
25、ed. 4.5 Surface When the catheter is ready for use (i.e. treated according to the manufacturers instructions) and is examined by normal or corrected-to-normal vision, the surface of the shaft, tip, and eyes shall appear free from extraneous matter. The shaft and any openings in the tip shall be desi
26、gned so as to minimize the risk of serious injury to mucous membranes. 4.6 Tensile properties When tested as described in annex B of EN 1618, the catheter shall not break and the catheter and connector shall not become separated at an applied force of 15 N or less.Page 4 EN 12439:1998 BSI 04-1999 4.
27、7 Collapse 4.7.1 When tested as described in 4.7.2, the catheter shall not collapse. 4.7.2 Place the catheter, with its eyes blocked, in a water bath at a temperature of (37 2)8C and keep it in the bath until temperature equilibrium has been reached. Apply a pressure of210 kPa to the catheter for a
28、period of 15 s. Examine the catheter for signs of collapse. 4.8 Air leakage When tested as described in annex C of EN 1618 at a test pressure of 10 kPa, the joint between the catheter and the connector shall not leak. 4.9 Sterility The catheter shall comply with EN 556:1994 + A1:1998. 5 Labelling In
29、 addition to the requirements of EN 1041, the following product-specific details shall be presented on the individual packaging: a) outer diameter, in millimetres, as designated in Figure 1; b) effective length, in millimetres, as designated in Figure 1; c) if the product contains latex, it shall be
30、 labelled to that effect. NOTE Other units of measurement can be used in addition to the SI units specified in 5a and 5b. Annex A (informative) Bibliography EN 30993, Biological evaluation of medical devices.blankBSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | |
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