EN 13544-2:2002+A1:2009
(Main)Respiratory therapy equipment - Part 2: Tubing and connectors
Respiratory therapy equipment - Part 2: Tubing and connectors
This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases.
The interface specifications are given to ensure interchangeability of respiratory therapy equipment thereby enabling patients to receive continuous treatment in all these clinical situations.
Weight-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices such as humidifiers or nebulizers can be attached.
NOTE This standard does not specify the devices where these connectors have to be used. It is expected that specific device standards will specify the devices where these connectors are going to the used e.g. EN ISO 10651 4, EN 738-1 and EN 13220.
Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke
Dieser Teil von EN 13544 legt die Anforderungen an Schlauchsysteme fest, die für Geräte zur therapeu-tischen Verabreichung von Beatmungsgasen bei der häuslichen Pflege, ambulanten Behandlung und in der Krankenhauspraxis verwendet werden. Festgelegt sind auch die Schnittstellen zu diesen Geräten, z. B. Nippel und Schraubverbindungen. Diese Schlauchsysteme werden hauptsächlich für Sauerstoff, Luft oder Gemische dieser Gase verwendet.
Schnittstellen wurden festgelegt, um die Austauschbarkeit von Geräten für die Atmungstherapie sicher-zustellen und damit eine kontinuierliche Behandlung von Patienten in allen klinischen Situationen zu ermöglichen.
Gewichtstragende Schraubverbindungen wurden zur Verwendung für den Ausgang, z. B. von Durchfluss-messgeräten, festgelegt, an denen Geräte wie Anfeuchter oder Vernebler angeschlossen werden können.
ANMERKUNG In dieser Norm werden nicht die Geräte festgelegt, für die diese Verbindungen zu verwenden sind. Es wird erwartet, dass spezielle Produktnormen die Geräte festlegen, für die diese Verbindungsstücke zu verwenden sind, z. B. EN ISO 10651-4, EN 738-1 und EN 13220.
Équipement de thérapie respiratoire - Partie 2: Tubes et raccords
Dihalna oprema za zdravljenje - 2. del: Cevke in priključki
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Atemtherapiegeräte - Teil 2: Schlauchsysteme und VerbindungsstückeEquipement de thérapie respiratoire - Partie 2: Tubes et raccordsRespiratory therapy equipment - Part 2: Tubing and connectors11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13544-2:2002+A1:2009SIST EN 13544-2:2003+A1:2009en,fr,de01-november-2009SIST EN 13544-2:2003+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13544-2:2002+A1
September 2009 ICS 11.040.10 Supersedes EN 13544-2:2002English Version
Respiratory therapy equipment - Part 2: Tubing and connectors Equipement de thérapie respiratoire - Partie 2: Tubes et raccords
Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke This European Standard was approved by CEN on 1 August 2002 and includes Amendment 1 approved by CEN on 30 July 2009.
CEN 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 application to the CEN Management Centre or to any CEN member.
This 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 CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-2:2002+A1:2009: ESIST EN 13544-2:2003+A1:2009
Page Foreword . 31Scope . 42Normative references . 43Nipples . 43.1Dimensions . 43.2Performance . 44Weight-bearing screw-threaded connectors . 45Tubing . 45.1General . 46Marking of tubing, labels and packaging . 77Packaging . 78Usability . 89Clinical evaluation . 8Annex A (normative)
Test methods . 9A.1Apparatus . 9A.2Method of test for strength of nipple . 9A.3Method of test for resistance to gas flow of tubing . 12A.4Method of test for security of connection between end connector and tubing . 13A.5Method of test for security of connection of end connectors and nipple . 13A.6Method of test for resistance to kinking . 14Annex B (normative)
Weight-bearing screw-threaded connectors for oxygen and air . 16Annex C (informative)
Information on method of testing security of connections . 17Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 18 SIST EN 13544-2:2003+A1:2009
EN 13544-2 :2002+A1:2009 (E) 3
Foreword This document (EN13544-2:2002+A1:2009) has been prepared by Technical Committee CEN /TC 215, "Respiratory and anaesthetic equipment", 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 March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2009-07-30. This document supersedes EN 13544-2:2002. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). Annexes A and B are normative.
Annex C is informative. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN 13544 consists of the following parts, under the general title Respiratory therapy equipment.
Part 1: Nebulizing systems and their components
Part 2: Tubing and connectors
Part 3: Air entrainment devices According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EN 13544-2 :2002+A1:2009 (E) 5 c) designed and manufactured to minimize health risks by leaching of substances from tubing during normal use to levels below those assumed to be non-toxic; ! d) if phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact with the patient the medical device shall be labelled accordingly. If such devices are used for the treatment of children or treatment of pregnant or nursing women, the residual risk has to be identified and stated in the instructions for use. NOTE Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction." Evidence shall be provided by the manufacturer on request. 5.1.1 Resistance to gas flow of tubing When tested as described in A.3, the resistance to flow shall not exceed 0,9 kPa/m. 5.1.2 End connectors Tubing for respiratory therapy equipment shall terminate at each end with a connector able to produce a secure connection conforming to 5.1.4 to the nipple specified in clause 3. NOTE Connectors can either be formed in the material of the tubing or can be joined to the tubing by e.g. welding or adhesives. SIST EN 13544-2:2003+A1:2009
Key l1 10 mm datum l2 12 mm minimum to shoulder or projection NOTE The axis of the nipple can be curved. a) Basic profile and nominal dimensions of nipple 6.353.5 2 û
inc.l1l2 Key l1 10 mm datum with a minimum of two corrugations within this length l2 12 mm minimum to shoulder or projection NOTE The external diameter of all corrugations falls on the profile of the nipple as shown in 1a. The shape of the corrugations is given as an example. b) Dimensions for corrugated nipple Figure 1 — Nipple for respiratory therapy equipment 5.1.3 Security of joint between end connector and tubing When tested as described in A.4, if the end connector is joined to the tubing, the end connector shall not become detached from the tubing. SIST EN 13544-2:2003+A1:2009
EN 13544-2 :2002+A1:2009 (E) 7 5.1.4 Security of connection of end connectors to nipple When tested as described in A.5, heavy duty tubing shall not become detached from the test nipple. NOTE See annex C for information on the method of testing the security of connection between an end connector and a nipple. 5.1.5 Resistance to kinking When tested as described in A.6, the flow through the kinked tubing shall be not less than 75 % of the initial flow. 6 Marking of tubing, labels and packaging Tubing, labels, and/or packaging shall contain the following as applicable : !name and address of the manufacturer and the name and address of authorized representative where the manufacturer does not have a registered place of business in the European Community;" !if the intended purpose of the device is not obvious to the operator, the device shall be provided with instructions for use. The instructions for use shall contain the date of issue or the latest revision;" device identification and content information ; symbol STERILE in accordance with EN 980 together with the method of sterilization ; batch code, preceded by the symbol LOT in accordance with EN 980, or serial number ; declaration of the maximum pressure the tubing shall withstand at ambient conditions specified in Table A.1 ; !date by which the device can be used, expressed as the year and month. For single use devices the manufacturer shall disclose the risks associated with reusing in the instructions for use or upon request; NOTE Manufacturer's attention is drawn to the regulatory provision for a consistent use of indication for single use devices. " indication that the device is for single use ; any special storage and/or handling conditions ; any warning and/or precaution to take ; recommended method(s) of cleaning, disinfection and sterilization ; device packaging and/or labelling shall differentiate between the same or similar products, both sterile and non-sterile, placed on the market by the same manufacturer ; packages containing parts made of antistatic or conductive material shall be clearly marked with the word “ANTISTATIC” or “CONDUCTIVE”. 7 Packaging The method of packaging should be designed to minimize the risk of kinking of the tubing occurring while in storage. SIST EN 13544-2:2003+A1:2009
Check compliance by inspection of the usability engineering file. 9 Clinical evaluation A clinical evaluation shall be performed and documented in the risk management fi
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