13/30290370 DC : 0
NA
Status of Standard is Unknown
BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
Hardcopy , PDF
English
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 |
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