DIN EN ISO 80369-6-2016 Small bore connectors for liquids and gases in healthcare applications - Part 6 Connectors for neuraxial applications (ISO 80369-6 2016) German version EN I.pdf
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1、November 2016 English price group 23No 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 11.040.25!%p“2587791www.din.deD
2、IN EN ISO 80369-6Small bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications (ISO 803696:2016);English version EN ISO 803696:2016,English translation of DIN EN ISO 80369-6:2016-11Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gas
3、e in medizinischen Anwendungen Teil 6: Verbindungsstcke fr neuroaxiale Anwendungen (ISO 803696:2016);Englische Fassung EN ISO 803696:2016,Englische bersetzung von DIN EN ISO 80369-6:2016-11Raccords destins des applications en contact avec le systme nerveux (neuraxiales) Partie 6: Raccords destins de
4、s applications en contact avec le systme nerveux (neuraxiales) (ISO 803696:2016);Version anglaise EN ISO 803696:2016,Traduction anglaise de DIN EN ISO 80369-6:2016-11www.beuth.deDocument comprises 58 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be cons
5、idered authoritative.11.16 DIN EN ISO 80369-6:2016-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 80369-6:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices (Secretariat: ANSI, USA)
6、in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Commi
7、ttee NA 063-01-11 AA Kleinlumige Konnektoren fr Flssigkeiten und Gase zur Verwendung im Gesundheitsbereich. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 594-1 DIN EN 20594-1 ISO 3040 DIN EN ISO 3040 ISO 7886-1 DIN EN ISO 7886-1 ISO 8
8、185 DIN EN ISO 8185 ISO 14971 DIN EN ISO 14971 ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 80369-1 DIN EN ISO 80369-1 ISO 80369-2 DIN EN ISO 80369-2 ISO 80369-3 DIN EN ISO 80369-3 ISO 80369-5 DIN EN ISO 80369-5 ISO 80369-7 DIN EN ISO 80369-7 ISO 80369-20 DIN EN ISO 80369-20 IEC 606
9、01-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-11 DIN EN 60601-1-11 (VDE 0750-1-11) IEC 62366-1 DIN EN 62366-1 (VDE 0750-241-1) CEN/CR 13825 DIN-Fachbericht 88 DIN EN ISO 80369-6:2016-11 3 National Annex NA (informative) Bibliography DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringe
10、s, needles and certain other medical equipment Part 1: General rules DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-11 (VDE 0750-1-11), Medical electrical equipment Part 1-11: General requirements for b
11、asic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment DIN EN 62366-1 (VDE 0750-241-1), Medical devices Part 1: Application of usability engineering to medical devices DIN EN ISO
12、3040, Geometrical product specifications (GPS) Dimensioning and tolerancing Cones DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing co
13、nnectors DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual use DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems DIN EN ISO 14971, Medical devices Application of risk management to med
14、ical devices DIN EN ISO 80369-1, Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements DIN EN ISO 80369-2, Small bore connectors for liquids and gases in healthcare applications Part 2: Connectors for breathing systems and driving gases applications DIN
15、EN ISO 80369-3, Small bore connectors for liquids and gases in healthcare applications Part 3: Connectors for enteral applications DIN EN ISO 80369-5, Small bore connectors for liquids and gases in healthcare applications Part 5: Connectors for limb cuff inflation applications DIN EN ISO 80369-7, Sm
16、all bore connectors for liquids and gases in healthcare applications Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications DIN EN ISO 80369-20, Small bore connectors for liquids and gases in healthcare applications Part 20: Common test methods DIN-Fachbericht 88, Luer
17、fittings DIN EN ISO 80369-6:2016-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-6 April 2016 ICS 11.040.25 English version Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO
18、 80369-6:2016) Raccords destins des applications en contact avec le systme nerveux (neuraxiales) - Partie 6: Raccords destins des applications en contact avec le systme nerveux (neuraxiales) (ISO 80369-6:2016) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendu
19、ngen - Teil 6: Verbindungsstcke fr neuroaxiale Anwendungen (ISO 80369-6:2016) This European Standard was approved by CEN on 20 February 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the sta
20、tus 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-CENELEC Management Centre or to any CEN and CENELEC member. This European Standard exists in three official versions (Englis
21、h, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies
22、 and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Po
23、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. R
24、ef. No. EN ISO 80369-6:2016 EEuropean foreword .3Introduction 81 * Scope 102 Normative references . 103 Terms and definitions 114 General requirements 124.1 General requirements for the neuraxial application 124.2 * Material used for small-bore connectors . 134.3 Type tests . 135 Dimensional require
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