1、DEUTSCHE NORM Januarv 2001 Enteral feeding catheters and enteral giving sets for Design and testing English version of DIN EN 1615 single use and their connectors DIN EN 1615 - ICs 11.040.20 Supersedes April 1997 Katheter und berleitungsgerte zur enteralen Ernhrung und ihre Konnektoren zur einmalige
2、n Verwendung - Ausfhrung und Prfung edition. European Standard EN 1615 : 2000 has the status of a DIN Standard. A comma is used as the decimal marker. National foreword This standard has been prepared by CEN/TC 205 Non-active medical devices. The responsible German body involved in its preparation w
3、as the Normenausschuss Medizin (Medical Standards Committee), Technical Committee Katheter, Drainagen. Amendments This standard differs from the April 1997 edition in that four connector types have been specified and the requirements have been amended. Previous editions DIN 13280: 1987-02; DIN EN 16
4、1 5: 1997-04. EN comprises 12 pages. No pari of this standard may be reproduced without the prior permission of Y Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, s the exclusive right of sale for German Standards (DIN-Normen). Ref. No. DIN EN 161 5 : 2001 -0 En
5、glish price group 08 Sales No. 1108 05.01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1615 October 2000 ICs 11.040.20 Supersedes EN 161 5 : 1997. English version Enteral feeding catheters and enteral giving sets for single use and their connectors Design and testing Sondes et dispositifs de
6、 nutrition entrale non rutilisables et leurs raccords - Conception et essais Katheter und berleitungsgerte zur enteralen Ernhrung und ihre Konnektoren zur einmaligen Verwen- dung - Ausfhrung und Prfung This European Standard was approved by CEN on 2000-09-16. CEN members are bound to comply with the
7、 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 such national stand- ards may be obtained on application to the Central Secretariat o
8、r 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 the same status as the official versi
9、ons. CEN members are the national standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. CEN European Committee for Standardizatio
10、n Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 2000. CEN - All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN 1615 : 2000 E Page 2 EN 161 5 : 2000 Contents Forewo
11、rd I nt roduction 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements Bibliography Page 2 3 4 4 5 5 12 Foreword This European Standard has been prepared by Technical Committee CENTTC 205 “Non- active medical devices“, the secretariat of which is held by BSI. This European Standard
12、replaces EN 1615:1997. 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 conflicting national standards shall be withdrawn at the latest by April 2001. According to the CENEENELEC In
13、ternal 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, Portugal, Spain, Sweden, Switzerla
14、nd and the United Kingdom. Page 3 EN 1615 : 2000 Introduction This European Standard specifies requirements for single-use enteral feeding catheters and enteral giving sets and their connector systems. The requirements for enteral feeding catheters, giving sets and their connections are specified so
15、 that, when used in current clinical practice, these devices do not compromise the clinical condition or the safety of patients. Some general requirements are covered by reference to other European standards listed in the normative references clause. This European Standard contains informative refer
16、ences to other European Standards listed in the Bibliography. Enteral feeding catheters are intended for human enteral nutrition. They are designed to pass the nutrition solutions through the nose or mouth, or by gastrostomy, jejunostomy or oesophagostomy . Both enteral giving sets and enteral feedi
17、ng catheters are often used with enteral nutrition pumps. The performance and connecting system requirements are specified so that both devices and their connections perform safely. It is important that enteral giving sets should not be able to be connected to parenteral intravascular catheters or a
18、ny other catheter with a female Luer connector. The requirements for the connecting systems prevent this form of misconnection. There are many enteral giving sets and enteral feeding catheters on the market which perform satisfactorily. This standard specifies three connectors suitable for enteral g
19、iving sets. It has not been found possible or desirable to limit the standard to only one connector. This places the onus on the designers 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
20、the appropriate clauses of this standard. The report from the Task Force Group “Luer Fittings” under the auspices of the CEN Health Care Forum has been noted. A revision of the present standard will be undertaken when an appropriate solution has been decided for alternative connector systems for ent
21、eral use. It was not considered necessary to provide a colour code on the enteral giving set, because the connectors specified for the enteral 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 c
22、atheter, and this could cause confusion with any colour suggested for coding the enteral giving set. Page 4 EN 161 5 : 2000 1 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 sy
23、stems. Requirements for radiodetectable enteral feeding catheters are not given in this standard. NOTE 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
24、 accepted standard test method for radiodetectability, but research to develop a standard method of test is being considered. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For d
25、ated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative documents indicated below. For un
26、dated references, the latest edition of the normative documents referred to applies (including amendments). EN 550, Sterjlization of medical devices - Validation and routine control of ethylene oxide sterjliza tion. EN 552, Sterilization of medical devices - Validation and routine control of sterili
27、zation by irra dia tion. EN 554, Sterilization of medical devices - Validation and routine control of sterilization 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 intra
28、vascular catheters - Test methods for common properties. EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, 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
29、1: General requirements (IS0 594- 1: 7986). Page 5 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 enter
30、al feeding catheter (see Figure 1) 3.2 enteral feeding 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
31、at least the following: a) either an integral nutrient container or a means of effecting connection to a nutrient container; b) flexible tubing; 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 c
32、hamber, a pump insert, a means for regulating and/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
33、 for parenteral administration. 4.1 -1 Tensile properties The flexible tubing pari of the enteral giving set shall withstand a linear tensile force of 15 N without rupture or cracking when tested in accordance with EN 161 8:1997, annex B. Any joints or connections within the enteral giving set shall
34、 also withstand a linear tensile force of 15 N. 4.1.2 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 B); b) it shall be a female 6% (
35、Luer) connector, slip or lock (“Type C) conforming to EN 20594-1 or EN 1707; Page 6 EN 161 5 : 2000 c) 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
36、with a female 6% (Luer) connector, slip 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
37、it. The dimensions of the connector 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 shal
38、l be pressurized with water to a minimum 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 descri
39、bed in EN 1618:1997, annex C. All parts 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 gi
40、ving sets shall be tested as described in EN 1618:1997, annex C. All parts of the enteral giving set shall show no leakage after 30 s. 4.1.4 Sterility 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 ac
41、cordance with EN 550, EN 552 or EN 554. Page 7 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 designed to mate with the conne
42、ctor provided on the enteral giving set (see 4.1.2). 4.2.2 Tensile properties 4.2.2.1 Nasogastric 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 catheters of outside diam
43、eter 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 shall withstand without r
44、upture or cracking a linear tensile force of either : U) 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 161 8: 1997, annex B, the
45、 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 cathete
46、rs 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. 4.3 Connector 4.3.1 Tensile properties Prior to testing a co
47、nnection for tensile strength, use of the connection shall be simulated as follows: a) the connector on the enteral feeding catheter shall be connected to an appropriate enteral giving set connector (either an actual enteral giving set connector or a fitment constructed to the correct dimensions); t
48、he assembled connection shall be kept at (20 -t 2) OC for 5 days; b) Page 8 EN 161 5 : 2000 c) twice each day the enteral feeding catheter shall be disconnected from the enteral giving set connector and, after a period not exceeding 2 min, it shall be reconnected. The assembled connection shall with
49、stand a linear tensile separation force of 15 N in accordance with EN 161 8:1997, annex F. 4.3.2 Liquid leakage Prior to testing for liquid leakage the enteral feeding catheter shall be connected to the appropriate enteral feeding set connector as specified in 4.1.2 and all openings shall be sealed. Following this, the assembled connection shall be pressurized with water to 50 kPa. The connection shall show no leakage at a pressure of 50 kPa for 2 min when tested as described in EN 161 8:1997, annex C. 4.4 Biocompatibility Both the enteral giving set and the enteral feedin
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