Name: CSA Z17510.2 : 2009
Brand: CSA

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

Published date

01-01-2009

Publisher

Canadian Standards Association

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information to be supplied by the manufacturer
5 Construction requirements
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

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

DocumentType	Standard
PublisherName	Canadian Standards Association
Status	Current
SupersededBy	CSA Z17510 : 2015
Supersedes	CSA Z17510.2 : 2003

CSA Z17510.1 : 2010

SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT

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
CSA Z17510.1 : 2010	SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
CSA C22.2 No. 60601.1.1 : 2002	MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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
CSA C22.2 No. 60601.1 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
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
CAN/CSA-Z23328-2-03 (R2018)	Breathing System Filters for Anaesthetic and Respiratory Use - Part 2: Non-Filtration Aspects (Adopted ISO 23328-2:2002, first edition, 2002-10-15)