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DIN EN ISO 17510-2:2009-07

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
Available format(s)

Hardcopy , PDF

Superseded date

07-03-2021

Language(s)

English

Published date

01-01-2009

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Informationen des Herstellers
5 Konstruktive Anforderungen
6 Erschütterung und Geräusche
Anhang A (informativ) Begründung
Anhang B (normativ) Prüfverfahren für Abgasfluss
Anhang C (normativ) Strömungswiderstand (Druckabfall)
Anhang D (normativ) Druckprüfung des Antiasphyxieventils
Anhang E (normativ) Atmung beim Ersten Fehler - Bestimmung
         des inspiratorischen und expiratorischen
         Strömungswiderstands
Anhang F (normativ) CO[2]-Rückatmung
Anhang G (normativ) Erschütterung und Geräusche
Anhang H (informativ) Leitfaden zu den durch den Hersteller
         anzugebenden Informationen
Anhang I (informativ) Verweisung auf die grundlegenden
         Prinzipien
Anhang J (informativ) Umweltgesichtspunkte
Anhang K (informativ) Terminologie - Alphabetisches
         Verzeichnis definierter Begriffe
Anhang ZA (informativ) Zusammenhang zwischen diesem
          Dokument und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG
Literaturhinweise

Dieses Dokument legt Anforderungen an Masken und Zubehörteile, einschliesslich aller Atemschläuche, fest, die erforderlich sind, um die Patientenanschlussöffnung des Schlafapnoe-Atemtherapiegeräts mit einem Patienten zu verbinden, und die bei Anwendung der Schlafapnoe-Atemtherapie eingesetzt werden, z. B. Nasenmasken, Abgasöffnungen, Atemschläuche und Kopfgeschirr.

DocumentType
Standard
Pages
39
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded

DIN EN ISO 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

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AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
DIN EN ISO 5356-2:2013-03 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012)
VDE 0750-1-1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
DIN EN ISO 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001

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