EN ISO 17510-2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
30-03-2022
11-03-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information to be supplied by the manufacturer
5 Construction requirements
5.1 Mask connectors
5.2 Biocompatibility
5.3 Protection against rebreathing
5.4 Cleaning, disinfection and sterilization
5.5 Breathing during single fault condition
5.6 Breathing system filter
6 Vibration and noise
Annex A (informative) - Rationale
Annex B (normative) - Exhaust flow test procedure
Annex C (normative) - Resistance to flow (pressure
drop)
Annex D (normative) - Anti-asphyxia valve pressure
testing
Annex E (normative) - Breathing during single fault
condition - Determination of the inspiratory
and expiratory resistance
Annex F (normative) - CO[2] rebreathing
Annex G (normative) - Vibration and noise
Annex H (informative) - Guide to information to be
supplied by the manufacturer
Annex I (informative) - Reference to the essential
principles
Annex J (informative) - Environmental aspects
Annex K (informative) - Terminology - Alphabetized
index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
ISO 17510-2:2007 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear.ISO 17510-2:2007 does not cover oral appliances.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes PREN ISO 17510-2. (08/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| 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 |
| NEN EN ISO 17510-2 : 2009 | Identical |
| NS EN ISO 17510-2 : 2009 | Identical |
| DIN EN ISO 17510-2:2009-07 | Identical |
| PN 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 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 |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 |
| 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 |
| 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 |
| 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 |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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