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BS EN ISO 17510-2:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Masks and application accessories
Available format(s)

Hardcopy , PDF

Superseded date

19-02-2020

Language(s)

English

Published date

30-04-2009

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

Applicable to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient.

Committee
CH/121/5
DevelopmentNote
Supersedes 01/560291 DC (02/2003) Supersedes 06/30127484 DC. (11/2007) Supersedes 08/30192480 DC. (04/2009)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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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