Name: UNI EN ISO 17510-2 : 2009
Brand: UNI

UNI EN ISO 17510-2 : 2009

Superseded

View Superseded by

SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES

Superseded date

05-09-2022

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

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

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 17510:2020 UNI EN ISO 17510-2 : 2020
Supersedes	UNI EN ISO 17510-2 : 2008

Standards	Relationship
ISO 17510-2:2007	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
NS EN ISO 17510-2 : 2009	Identical
DIN EN ISO 17510-2:2009-07	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