DIN EN 12342:2010-01
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
Hardcopy , PDF
01-02-2015
English
01-01-2010
Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Werkstoffe
5 Ausführung
6 Länge
7 Durchflusswiderstand
8 Verbindungsstücke
9 Lecksicherheit
10 Zunahme des Durchflusswiderstandes bei Biegung
11 Compliance von Atemschläuchen
12 Vom Hersteller bereitzustellende Informationen
13 Elektrischer Widerstand
14 Anforderungen an steril gelieferte Atemschläuche
15 Kennzeichnung
16 Gebrauchstauglichkeit
17 Klinische Bewertung
18 Biophysikalische oder an Modellen durchgeführte
Untersuchungen
Anhang A (normativ) Prüfung des Durchflusswiderstandes
Anhang B (normativ) Prüfung der Sicherheit der Verbindung
des glatten Endes mit einem Verbindungsstück
geeigneter Grösse mit Aussenkegel
Anhang C (normativ) Prüfung der Sicherheit der Verbindung
eines Adapters mit dem Atemschlauch
Anhang D (normativ) Prüfung der Lecksicherheit
Anhang E (normativ) Prüfung der Zunahme des
Durchflusswiderstandes bei Biegung
Anhang F (normativ) Prüfung der Compliance
Anhang G (informativ) Empfehlungen für Werkstoffe und
Ausführung
Anhang H (informativ) Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
Europäischen Norm und den grundlegenden
Anforderungen der EG-Richtlinie 93/42/EWG
Describes the basic requirements for breathing tubes and breathing tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifiers and nebulizers.
| DevelopmentNote |
A transition period, as set out in DIN EN ISO 5367 issue 02-2015 exists until 31-10-2017. (02/2015)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 12342:1998+A1:2009 | Identical |
| NBN EN 12342 : 1998 + A1 2009 | Identical |
| NS EN 12342 : 1998 + A1 2009 | Identical |
| UNE-EN 12342:1999 | Identical |
| NF EN 12342 : 1998 + A1 2009 | Identical |
| NEN EN 12342 : 1998 + A1 2009 | Identical |
| I.S. EN 12342:1999 | Identical |
| BS EN 12342 : 1998 | Identical |
| SN EN 12342 : 1999 + A1 2010 | Identical |
| UNI EN 12342 : 2009 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 468:1982 | Surface roughness — Parameters, their values and general rules for specifying requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| EN 1281-1:1997/A1:1998 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 30993-1 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS |
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