1、September 2012DEUTSCHE NORM E n g l i s h p r i c e g r o u p 6No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.0
2、40.25!%F:1“2352314www.din.deDIN 13273-8C a t h e t e r f o r m e d i c a l u s e P a r t 8 : E p i d u r a l c a t h e t e r s ,English translation of DIN 13273-8:2012-09K a t h e t e r f r d e n m e d i z i n i s c h e n B e r e i c h T e i l 8 : E p i d u r a l k a t h e t e r ,Englische bersetzun
3、g von DIN 13273-8:2012-09C a t h t e r s u s a g e m d i c a l P a r t i e 8 : C a t h t e r s e p i d u r a l e s ,Traduction anglaise de DIN 13273-8:2012-09www.beuth.deDocument comprises 8 pagesDDIN-Normenausschuss Medizin (NAMed)DIN-Sprachendienst02.16DIN 13273-8:2012-09 2 A comma is used as the
4、decimal marker. Contents Page Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Schematic diagram of a catheter used as epidural catheter .5 5 Requirements and testing .6 5.1 Radiopacity .6 5.2 Transparency of the tubing material6 5.3 Marking .6 5.4 Marking of the epidural a
5、ccess point 6 5.5 Force at break of the catheter 6 5.6 Tensile strength between connector and catheter .6 5.7 Freedom from leakage of the assembled treatment unit .6 5.8 Connector .6 5.9 Wire element .7 5.10 Catheter holes 7 5.11 Patency of assembled epidural unit 7 5.12 Kinking 7 5.13 Movability of
6、 the catheter through the needle 7 5.14 Applicator .7 6 Designation of nominal size .7 7 Information to be supplied by the manufacturer 7 8 Disposal 7 Bibliography 8 DIN 13273-8:2012-09 3 Foreword This document was prepared by Working Committee NA 063-01-02 AA Katheter, Drainagen of the Normenaussch
7、uss Medizin (Medicine Standards Committee (NAMed). This document is a further part of the DIN 13273 standards series. Up to now the content of this document has not been covered by either national or international standards. If, in the future, it is decided to submit a proposal for a new work item t
8、o the ISO Technical Committee responsible for this topic, ISO/TC 84, then it is intended that this document be submitted as the national proposal. DIN 13273 consists of the following parts, under the general title Catheters for medical use: Part 7: Determination of the x-ray attenuation of catheters
9、 Requirements and testing Part 8: Epidural catheters The DIN 13273 series of standards was initiated in July 1980 with the publication of Part 1 “Female connectors” and Part 2 “Single-use suction catheters” and finalized for the time being in February 1996 with Part 7 “Determination of the x-ray att
10、enuation of catheters Requirements and testing”. Since then most of the Parts of the DIN 13273 series have been replaced by European Standards. An overview is given in Table 1. Table 1 Scope of the DIN 13273 standards series, Catheters for medical use DIN 13273 Catheters for medical use Replaced by
11、Remark Part 1: Female connectors - Withdrawn without replacement in 2002-10, with DIN EN 1733 recommended to be used instead. In 2009-08 DIN EN 1733 was replaced by DIN EN ISO 8836. Part 2: Single-use suction catheters - Withdrawn without replacement in 2002-10, with DIN EN 1733 recommended to be us
12、ed instead. In 2009-08 DIN EN 1733 was replaced by DIN EN ISO 8836. Part 3: Additional requirements for bladder catheter - Withdrawn without replacement in 2007-07; partially covered by DIN EN 1616. Part 4: Rectal catheter for single use DIN EN 12439 Replaced in 1996-09. Part 5: Intravenous catheter
13、, central, for single use DIN EN ISO 10555-1 Replaced in 1996-11. Part 6: Intravenous catheter, peripheral, for single use DIN EN ISO 10555-1 Replaced in 1996-11. Part 7: Determination of the x-ray attenuation of catheters Requirements and testing - Issued in 2003-08, still valid. Part 8: Epidural c
14、atheters - Existing standard. DIN 13273-8:2012-09 4 1 Scope This standard specifies general requirements for sterile single use catheters and connectors intended for epidural use. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are
15、 indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies DIN 13273-7, Catheters for medical use Part 7: Determination of the x-ray attenuation of catheters Requir
16、ements and testing DIN EN 13868, Catheters Test methods for kinking of single lumen catheters and medical tubing DIN EN ISO 8836, Suction catheters for use in the respiratory tract DIN EN ISO 10555-1:1996-11, Sterile, single-use intravascular catheters Part 1: General requirements (ISO 10555-1:1995)
17、 ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use1)3 Terms and definitions For the purposes of this document, the terms and definitions given in DIN EN ISO 8836 and DIN EN ISO 10555-1 and the following apply: 3.1 holes holes at the distal end of the catheter 3.2 outer dia
18、meter defined maximum diameter of the catheter intended to be inserted into the epidural needle Note 1 to entry: The diameter is specified in millimetres. 3.3 treatment unit entirety of the devices, accessories, disposables and consumables used for the patients treatment and/or diagnostics SOURCE: D
19、IN VDE 0753-4 (VDE 0753-4):2009-05 3.4 applicator utility for inserting the epidural catheter into the hub of the epidural needle 3.5 epidural needle needle intended to insert the epidural catheter into the epidural space 1) Obtainable at http:/www.beuth.de/ DIN 13273-8:2012-09 5 3.6 epidural cathet
20、er flexible tube consisting of one inner lumen intended to be partly inserted into epidural space Note 1 to entry: The flexible tube allows flow of fluid. 3.7 wire element device inside the epidural catheter to assist the insertion of the catheter 3.8 handle utility to grip the wire element 3.9 cath
21、eter connector subassembly intended to be connected to the proximal end of the catheter Note 1 to entry: The connector is usually designed according to DIN EN 1707 and DIN EN 20594-1 (“Luer connector”). It is anticipated that in future, once the DIN EN ISO 80369 series of standards is fully effectiv
22、e, connectors will be provided with a hub according to DIN EN ISO 80369-1 and a further standard which will deal more specifically with the application. 3.10 length of catheter length, measured from the distal to the proximal end of the catheter (excluding the catheter connector) Note 1 to entry: Th
23、e length is specified in millimetres or centimetres. 4 Schematic diagram of a catheter used as epidural catheter Figure 1 shows a schematic diagram of a catheter used as an epidural catheter. Key 1 epidural catheter 5 vertebral body of spinal column 2 epidural needle 6 distal end of the catheter in
24、epidural space 3 feeder 7 epidural space 4 skin 8 distal end of the epidural needle Figure 1 Schematic diagram of a catheter used as epidural catheter DIN 13273-8:2012-09 6 5 Requirements and testing 5.1 Radiopacity The catheter shall be radio-detectable. Compliance shall be demonstrated by DIN 1327
25、3-7 or ASTM F640. 5.2 Transparency of the tubing material The constitution of the catheter tubing shall be such that in the inner lumen the air/water phase boundary is visible over the whole length of the catheter. The area covered by the connector and the markings are exempted from this requirement
26、. 5.3 Marking The catheter shall be provided with markings at a length of 50 mm to 100 mm measured from the distal end. Length markings shall be positioned at regular intervals of 10 mm. Additional markings differing in design from the 10 mm markings should be provided at 100 mm, 150 mm and 200 mm.
27、Length markings for catheters intended for paediatric use shall be positioned beginning at 20 mm from the distal end. Markings at 50 mm and 100 mm shall differ in their design from the 10 mm markings. 5.4 Marking of the epidural access point The proximal end of the epidural catheter or the connector
28、 shall enable specific marking of the epidural access point. An appropriate utility for marking shall be provided together with the treatment unit. 5.5 Force at break of the catheter Testing of force at break is performed using a tensile testing apparatus. The clamping length shall be 10 mm. Testing
29、 force is dynamically applied at a cross-head speed of 200 mm/min. Catheters with an outer diameter 0,75 mm shall withstand a peak tensile force 5 N. Catheters with an outer diameter 0,75 mm shall withstand a peak tensile force 10 N. 5.6 Tensile strength between connector and catheter The connector
30、and catheter are assembled in accordance with the manufacturers instructions. A tensile force of 5 N is then applied within 2 s to 20 s. The catheter shall not separate from the connector over a period of 2 min. 5.7 Freedom from leakage of the assembled treatment unit The hub or connection fitting a
31、ssembly or any other part of the catheter shall not show liquid loss when tested in accordance with the method below. Compliance shall be demonstrated according to DIN EN ISO 10555-1:1996-11, Annex C. 5.8 Connector In its as-delivered condition, the connector shall be equipped with a cap. DIN 13273-
32、8:2012-09 7 5.9 Wire element The wire element shall not protrude from the distal end or lateral holes of the catheter. The wire element shall be equipped with a handle allowing safe removal of the wire element from the catheter. At a unit strain rate of 200 mm/min the peak tensile force for separati
33、on of the handle and wire element shall not be less than 15 N. The wire element shall be allowed to be removed from the catheter without compressing the catheter or tearing the wire element. 5.10 Catheter holes As, in practical applications, a maximum insertion depth of 3 cm to 5 cm into the epidura
34、l space is common, if present each lateral hole at the distal end of the catheter shall be positioned within the first 3 cm, measured from the distal end. Holes shall not have any sharp edges. The distal end of the catheter shall be rounded. 5.11 Patency of assembled epidural unit Patency for distil
35、led or deionized water shall be ensured in principle. 5.12 Kinking Compliance shall be demonstrated in accordance with DIN EN 13868. 5.13 Movability of the catheter through the needle The geometry of both the epidural catheter and the needle of a treatment unit shall be adjusted to each other in ord
36、er to guarantee flawless movability. 5.14 Applicator The applicator shall be designed in a way that allows a positive locking of the hub of the needle and the applicator. The applicator shall prevent the catheter from kinking during insertion into the needle. 6 Designation of nominal size The outer
37、diameter is expressed in mm and rounded to the next 0,05 mm. The catheter length is expressed in mm or cm. 7 Information to be supplied by the manufacturer The information to be supplied by the manufacturer shall comply with DIN EN ISO 10555-1 and shall also include: a warning indicating that no att
38、empt shall be made to withdraw the catheter (totally or partially) through the needle; an indication regarding properties of the catheter when used in MRI. 8 Disposal Information relating to safe and environmentally compatible disposal of single-use catheters should be provided (e.g. “Disposal of co
39、ntaminated devices shall be in accordance with the facilities biohazard handling procedures”). DIN 13273-8:2012-09 8 Bibliography DIN EN 1616, Sterile uretheral catheters for single use DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lo
40、ck fittings DIN EN 12439, Sterile rectal catheters for single use DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN ISO 9626, Stainless steel needle tubing for manufacture of medical devices DIN EN I
41、SO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 80369-1, Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements DIN VDE 0753-4 (VDE 0753-4):2009-05, Guideline for the safe use of medical products in dialysis treatment; Text in German and English BS 6196:1989, Specification for sterile epidural catheters and introducer needles for single use2)JIS T 3258, Sterile epidural catheters for single use2)2) Obtainable at http:/www.beuth.de/
