BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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) - Particular guidance and 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) - CO2 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
Bibliography
Terminology - Alphabetized index of defined terms
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements EU Directive 93/42/EEC

BS ISO 17510.

Committee	CH/121/5
DocumentType	Draft
Pages	43
PublisherName	British Standards Institution
Status	NA

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
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
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices