ISO 5359-2014 pdf free.Anaesthetic and respiratory equipment一Low-pressure hose assemblies for use with medical gases.
ISO 5359 specifies requirements for low-pressure hose assemblies intended for
use with the following medical gases:
— oxygen,
— nitrous oxide,
— medical air,
— helium,
— carbon dioxide,
— xenon,
— specified mixtures of the gases listed above,
— oxygen-enriched air,
— air for driving surgical tools,
— nitrogen for driving surgical tools,
and for use with vacuum.
1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute.
1.3 This International Standard does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.
NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are specified in CGA V-S 1281.
NOTE 2 Specifications forthe dimensions and allocation of sleeve indexed system (S1S) connectors are specified in AS 2896 1231.
NOTE 3 DimensIons and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in
ISO 18082 1111.
NOTE 4 Terminal units designed for quick connectors are specified in ISO 9170-1.
1.4 This International Standard does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.
1.5 ThIs International Standard does not specify the Intended uses of hose assemblies.
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 mnaximnum 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 1497 1:2007, Medical devices — Application of risk management to medical devices
ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
accessory
additional component for use WILI1 equipment in order
— to perform its intended use,
— to adapt the equipment to some special use,
— to facilitate the use of the equipment,
— to enhance the performance of the equipment,
— to enable the functions of the equipment to be integrated with those of other equipment
[SOURCE: IEC 60788:2004, 3.6]
3.2 accompanying document
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: IEC 60601-1:2005,3.4, modified — by replacing medical electrical equipment, medical electrical system by medical device and by deleting essential performance at the end of the definition.)ISO 5359 pdf free download.
Tags: Anaesthetic and respiratory equipment
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