1、STD-BSI BS EN LbL5-ENGL 2000 m Lb24667 0885b79 OLL m BRITISH STANDARD BS EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing The European Standard EN 1616:2000 has the status of a British Standard ICs 11.040.20 NO COPYING WOUT BSI P
2、EBMISSION EXCEPT As PEBMITFED BY COPYBIGHT LAW STD*BSI BS EN Lb15-ENGL 2000 Lb24bb9 0885680 633 BS EN 1616:2 This British Standard, having been prepared under the direction of the Health and Environment Sector Commiaee, was pubiished under the authority of the Standards Commitke and comes into effec
3、t on 15 December 2000 National foreword This British Standard is the officiai English ianguage version of EN 161Fj2. It supemedes BS EN 1615 1997 which is withdram The TJK participation in its preparation was entrusted to Technid committee cw27, Meicai piastics tubing, which has the responsibility t
4、o: - aid enquirers to understand the tea - present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informe - monitor related internaiional and European developments and promulgate them in the IJK. A list of organizations r
5、epresented on this committee can be obtained on request to its secrew. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards catalogue under the section entitled “International Standards Correspond
6、ence Index“, or by using the “Fhd“ 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 Standads are responsible for their correct application. Compliance with a British Standard does not of its
7、elf 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 14, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document waslastissued. Amendment
8、s issued since publication O BSI 1uN)o ISBN O 580 36668 5 STD-BSI BS EN LhJS-ENGL 2000 W Lb24bh9 0885683 77T W EUROPEAN STANDARD EN 1615 NORME EUROPENNE EUROPASCHE NORM October 2000 ICs 11 m0.20 Supersedes EN 16151997 English version Enteral feeding catheters and enteral giving sets for single use a
9、nd their connectors - Design and testing Sondes et dispositifs de nutrition entrale non rutilisables et leurs raccords - Conception et essais Katheter und Uerlelungsgetate zur enteralen Ernhrung und ihre Konnektoren zur einmaligen Verwendung - Aushrung und PNfung This European Standard was approved
10、by CEN on 16 September 2000. CEN members are bound to comply with the CENKENELEC 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 sich national st
11、andards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by traislation under the responsibility of a CEN member into its own language and notified
12、to the Central Secretariat has the same status as he 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 Uni
13、ted Kingdom. EUROPEAN COMMEE FOR STANDARDIZATION EUROPAISCHES KOMITEE FUR NORMUNG COMITE EUROPEEN DE NORMALISATION Central Secretariat: rue de Stassart, 36 8-1050 Brussels 8 2000 CEN All rights of exploitaton in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1615:
14、ZOOO E Contents Page Foreword Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements Bibliography 3 4 5 5 6 6 14 O BSI 12-2000 STD-BSI BS EN Lb15-ENGL 2000 Lb24bb9 OBB5b83 542 Page 3 EN 1615:2000 Foreword This European Standard has been prepared by Technical Committee CEN
15、ITC 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard replaces EN 161 31997. 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 2001, and conflict
16、ing national standards shall be withdrawn at the latest by April 2001. According to the CENICENELEC 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
17、, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Noway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Q BSI 12-2000 STDBBSI BS EN 1615-ENGL 2000 1624bb9 0885b84 489 Page 4 EN 1615:2000 Introduction This European Standard specifies requirements for single-use enteral feeding
18、 catheters and enteral giving sets and their connector systems. The requirements for enteral feeding catheters, giving sets and their connections are specified so that, when used in current clinical practice, these devices do not compromise the clinical condition or the safety of patients. Some gene
19、ral requirements are covered by reference to other European Standards listed in the normative references clause. This European Standard contains informative references to other European Standards listed in the Bibliography. Enteral feeding catheters are intended for human enteral nutrition. They are
20、 designed to pass the nutrition solutions through the nose or mouth, or by gastrostomy, jejunostomy or oesophagostomy. Both enteral giving sets and enteral feeding catheters are often used with enteral nutrition pumps. The performance and connecting system requirements are specified so that both dev
21、ices and their connections perform safely. It is important that enteral giving sets should not be able to be connected to parenteral intravascular catheters or any other catheter with a female Luer connector. The requirements for the connecting systems prevent this form of misconnection. There are m
22、any enteral giving sets and enteral feeding catheters on the market which perform satisfactorily. This standard specifies three connectors suitable for enteral giving sets. It has not been found possible or desirable to limit the standard to only one connector. This places the onus on the designers
23、and manufacturers of the enteral feeding catheters to provide connectors on their devices which mate with the connector on the enteral giving set and conform to the appropriate clauses of this standard. The report from the Task Force Group, Luer Fittings, under the auspices of the CEN Health Care Fo
24、rum has been noted. A revision of the present standard will be undertaken when an appropriate solution has been decided for alternative connector systems for enteral use. It was not considered necessary to provide a colour code on the enteral giving set, because the connectors specified for the ente
25、ral giving set will not fit into a female Luer fitting. Also, many enteral feeding catheters use a colour code on the connector to indicate the diameter of the catheter, and this could cause confusion with any colour suggested for coding the enteral giving set. Q BSI 12-2000 STDeBSI ES EN LbL5-ENGL
26、2000 Page 5 EN 1615:2000 I Scope This European Standard specifies requirements for the design and testing of single-use enteral feeding catheters, single-use enteral giving sets and their connection systems. Requirements for radiodetectable enteral feeding catheters are not given in this standard. N
27、OTE Enteral feeding catheters intended for insertion through the mouth or nose can be radiodetectable in their entirety or at the tip or by means of intermittent marks. At present there is no generally accepted standard test method for radiodetectability, but research to develop a standard method of
28、 test is being considered. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this European Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. Howe
29、ver, parties to agreements based on this European Standard are encouraged to investigate the possibility of applying the most recent edition of the normative documents indicated below. For undated references, the latest edition of the normative documents referred to applies (including amendments). E
30、N 550, Sterilization of medical devices - Validation and mutine control of ethylene oxide sterilization. EN 552, Sterilization of medical devices - Validation and mutine control of sterilization by irradiation. EN 554, Sterilization of medical devices - Validation and mutine control of sterilization
31、 by moist heat. EN 556+A1 , Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled “Sterile? EN 161 8: 1997, Catheters other than intravascular catheters - Test methods for common properties. EN 1707, Conical fittings with a 6 % (Luer) taper for syri
32、nges, needles and certain other medical equipment - Lock fittings. EN 20594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part I: General requirements (IS0 594-1:1986). Q BSI 12-2000 STDeBSI BS EN 1615-ENGL 2000 Lb2YbbS 0885b8b ,E!.5L = Page
33、 6 EN 1615:2000 3 Terms and definitions For the purposes of this European Standard the following terms and definitions apply. 3.1 enteral giving set medical device by which nutrient or diet is transferred from a nutrient or diet container to an enteral feeding catheter (see Figure I) 3.2 enteral fee
34、ding catheter medical device consisting of a flexible tube having one or more eyes and a connector, designed to introduce nutrient or diet into the gastro-intestinal tract 4 Requirements 4.1 Enteral giving set The enteral giving set shall consist of at least the following: a) b) flexible tubing; eit
35、her an integral nutrient container or a means of effecting connection to a nutrient container; c) a connector to make a connection with an enteral feeding catheter. NOTE 1 The enteral giving set can also be provided with other features, e.g. a drip chamber, a pump insert, a means for regulating and/
36、or stopping the flow through the enteral giving set. NOTE 2 The means of connection between the enteral giving set and the nutrient container (if it is not integral) is preferably a screw fitting or a means different from the piercing pin system used for parenteral administration. 4. I. I Tensile pr
37、operties The flexible tubing part of the enteral giving set shall withstand a linear tensile force of 15 N without rupture or cracking when tested in accordance with EN 1618:1997, annex B. Any joints or connections within the enteral giving set shall also withstand a linear tensile force of 15 N. 4.
38、1.2 Connector on the enteral giving set The connector on the enteral giving set shall conform to one of the following requirements: a) it shall have the dimensions given in either Figure 2 (“Type A”) or Figure 3 (“Type BY; Q BSI 12-2000 Page 7 EN 1615:2000 b) c) it shall be a female 6 % (Luer) conne
39、ctor, slip or lock (7ype CD) conforming to EN 20594-1 or EN 1707; it shall be an alternative connection system (including both an enteral giving set and an enteral feeding catheter) (“Type D“) which passes the tests specified in 4.3 and 4.4, but does not connect with a female 6 % (Luer) connector, s
40、lip or lock as specified in EN 20594-1 or EN 1707, as appropriate. NOTE There are a variety of connectors on the market. This standard provides for connectors which provide safe connection to an enteral feeding catheter which has a connector designed to mate with it. The dimensions of the connector
41、shall not be altered by deformation when connection to an enteral feeding catheter is attempted. 4.1.3 Liquid leakage test 4.1 3.1 Sets designed for use with a pump Prior to testing for liquid leakage all the openings shall be sealed. Following this, the set shall be pressurized with water to a mini
42、mum pressure equal to or greater than one of the following: a) b) the maximum operating pressure of the pump with which it is designed to be used; the pressure value it is able to withstand, as according to the label. Enteral giving sets shall be tested as described in EN 1618:1997, annex C. All par
43、ts of the enteral giving set distal to the pumping segment shall show no leakage after 2 min. 4.1.3.2 Gravity sets Prior to testing for liquid leakage all the openings shall be sealed. Following this, the set shall be pressurized with water to 20 kPa. Enteral giving sets shall be tested as described
44、 in EN 1618:1997, annex C. All parts of the enteral giving set shall show no leakage after 30 s. 4.1.4 Steity If the enteral giving set is to be labelled “Sterile“, the device shall be sterilized in accordance with EN 556+A1 and controlled and validated in accordance with EN 550, EN 552 or EN 554. O
45、 BSI 12-2000 STDOBSI BS EN Lb15-ENGL 2000 W lb24bb9 0885b88 024 9 Page 8 EN 1615:2000 4.2 Enteral feeding catheter 4.2.1 Connector on the enteral feeding catheter The enteral feeding catheter connector shall be a male 6 % (Luer) conical fitting conforming to EN 20594-1 or EN 1707 or shall be designe
46、d to mate with the connector provided on the enteral giving set (see 4.1.2). 4.2.2 Tensile properties 4.2.2.1 Nasogastnc feeding catheters When tested in accordance with EN 161 8: 1997, annex B, the catheter shall withstand without rupture or cracking a linear tensile force of either: a) 5 N for cat
47、heters of outside diameter 2 mm or less; or b) 15 N for catheters of outside diameter greater than 2 mm. 4.2.2.2 Percutaneous feeding catheters If the percutaneous feeding catheter has an introducer system, when tested in accordance with EN 1618:1997, annex B, the catheter and introducer system shal
48、l withstand without rupture or cracking a linear tensile force of either: a) 35 N for catheters of outside diameter 4 mm or less; or b) 75 N for catheters of outside diameter greater than 4 mm. If the catheter is designed to be pulled through the stomach wall, when tested in accordance with EN 1618:
49、1997, annex B, the catheter, the introducer part and any connection between them shall withstand without rupture or cracking a linear tensile force of either: a) 35 N for catheters of outside diameter 4 mm or less; or b) 75 N for catheters of outside diameter greater than 4 mm. All other percutaneous feeding catheters shall conform to 4.2.2.1. 4.2.3 Sterility If the enteral feeding catheter is to be labelled “Sterile“, the device shall be sterilized in accordance with EN 556+A1 and controlled and validated in accordance with EN 550, EN 552 or EN 554. O BSI 12-2000 Page 9
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