DIN EN ISO 17510-2:2009-07
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
03-07-2021
English
01-01-2009
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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Superseded
|
| Standards | Relationship |
| NS EN ISO 17510-2 : 2009 | Identical |
| SN EN ISO 17510-2 : 2009 | Identical |
| NF EN ISO 17510-2 : 2009 | Identical |
| BS EN ISO 17510-2:2009 | Identical |
| ISO 17510-2:2007 | Identical |
| UNI EN ISO 17510-2 : 2009 | Identical |
| I.S. EN ISO 17510-2:2009 | Identical |
| NBN EN ISO 17510-2 : 2009 | Identical |
| UNE-EN ISO 17510-2:2009 | Identical |
| EN ISO 17510-2:2009 | Identical |
| NEN EN ISO 17510-2 : 2009 | Identical |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| ISO 4871:1996 | Acoustics — Declaration and verification of noise emission values of machinery and equipment |
| ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
| DIN EN 61672-1:2014-07 | ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013) |
| DIN EN 60601-1-1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| DIN EN ISO 17664:2016-06 (Draft) | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN ISO 3744:2011-02 | Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010) |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| 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 |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| DIN EN ISO 5356-1:2015-06 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015) |
| 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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