DIN EN ISO 80369-1:2015-09 (Draft)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
07-03-2021
German
01-01-2015
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Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Werkstoffe für Verbindungsstücke
mit kleinem Durchmesser
5 Anforderungen an Verbindungsstücke mit
kleinem Durchmesser für spezifische
Anwendungen
5.1 Inkompatibilität von Verbindungsstücken
mit kleinem Durchmesser
5.2 Intravasculäre oder subkutane Anwendungen
5.3 Anwendungen in Atemsystemen und Antriebsgasen
5.4 Enterale Anwendungen
5.5 Urethrale und urologische Anwendungen
5.6 Anwendungen in Systemen mit aufblasbarer
Manschette für Gliedmassen
5.7 Neuroaxiale Anwendungen
5.8 Alternative Verbindungsstücke mit kleinem
Durchmesser
6 Verfahren zur Beurteilung einer vorgeschlagenen neuen
Ausführung eines Verbindungsstücks mit kleinem
Durchmesser zur Aufnahme in diese Normenreihe
6.1 Allgemeines
6.2 Einleitung eines Vorschlags
6.3 Verfahren zur Bewertung der Annehmbarkeit und der
Merkmale der nicht miteinander Verbindbarkeit
6.3.1 Ausführung
6.3.2 Ausführungsrealisierung
6.3.3 Verifizierung der Ausführung
6.3.4 Bestätigung der Ausführung
6.4 Überprüfung der Ausführung
6.5 Nachfolgende Teile dieser Normenreihe
Anhang A (informativ) Begründung
Anhang B (normativ) Mechanische Prüfungen zur
Bestätigung der Merkmale der nicht
miteinander Verbindbarkeit
Anhang C (informativ) Anwendungen von Verbindungsstücken
mit kleinem Durchmesser
Anhang D (informativ) Verweis auf grundlegende Prinzipien
Anhang ZA (informativ) Zusammenhang zwischen diesem
Dokument und den grundlegenden Anforderungen
der EG-Richtlinie 93/42/EWG
Literaturhinweise
Stichwortverzeichnis
| DevelopmentNote |
Supersedes DIN EN 15546-1. (04/2011) DRAFT 2015 issued in September 2015. (09/2015)
|
| DocumentType |
Draft
|
| Pages |
64
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| EN ISO 80369-1:2010 | Identical |
| ISO 80369-1:2010 | Identical |
| PREN ISO 80369-1 : DRAFT 2009 | Identical |
| DIN 13273-8:2012-09 | CATHETER FOR MEDICAL USE - PART 8: EPIDURAL CATHETERS |
| DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| DIN EN ISO 10079-3:2014-09 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
| DIN EN ISO 80369-20:2015-09 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015 |
| DIN ISO 11040-4:2007-10 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| DIN EN ISO 5359:2015-02 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| DIN EN ISO 5356-1:2015-06 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015) |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| DIN EN ISO 5356-2:2013-03 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
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