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ISO 5359-2014 pdf free download
ISO 5359-2014 pdf free download.Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
Matériel d’anesthésie et de reanimation respiratoire — Flexibles de raccordement a basse pression pour utilisation avec les gaz médicaux.
2 Normative references
The following documents, in whole or in part, are normatively referenced In this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Iso 1307:2006, Rubber and plastics hoses — hose sizes, minimum and maximum inside diameters, and tolerances on cut-to-length hoses
ISO 1402:2009, Rubber and plastics hoses and hose assemblies — Hydrostatic testing
ISO 8033:2006, Rubber and plastics hoses — Determination of adhesion between components
ISO 9170-1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007. Medical devices — Application of risk management to medical devices
ISO 1500 1:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
additional component [or use with equipment in order
— to perform its intended use,
— to adapt the equipment to some special use,
— to facilitate the use ol the equipment,
— to enhance the performance of the equipment.
— to enable the functions of the equipment to be integrated with those of other equipment
ISOURCE: IEC 60788:2004, 3.6]
document accompanying a medical device or an accessory (11) and containing information for the responsible organization (122) or operator, particularly regarding basic safety (13) [SOURCE: I EC 60601-1:2005,3.4, mod if ied — by replacing medical electrical equipment, medical electrical system by medical device and by deleting essential performance at the end of the definition.j
freedom from unacceptable risk directly caused by physical hazards (12) when a medical device is used under normal condition and single fault condition (124)
[SOURCE: IEC 60601-1:2005,3.10, modified — by replacing medical electrical equipment, medical electrical system by medical device.]
any of a range of male and female components intended to maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each particular gas
EXAMPLE Non-interchangeable screw-threaded connector (un) (NIST connector), diameter-index safety system connector (DISS connector), sleeve index system connector (SIS connector).
having characteristics which prevent connections between different gas services
ISOURCE: ISO 7396-1:2007, 3.14].ISO 5359-2014 pdf free download.
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