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EN ISO 5359:2014/A1:2017
Current
The latest, up-to-date edition.
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017)
11-29-2017
Foreword to Amendment A1
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test methods
6 Marking, colour coding and packaging
7 Information to be supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (informative) - Environmental aspects
Annex C (informative) - Reported regional and national
deviations of colour coding and nomenclature
for medical gases
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Describes 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; - oxygen 93; - nitrogen for driving surgical tools; and for use with vacuum.
Committee |
CEN/TC 215
|
DevelopmentNote |
Supersedes EN 739. (09/2008)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Supersedes |
Standards | Relationship |
ISO 5359:2014 | Identical |
UNE-EN ISO 5359:2015 | Identical |
NF EN ISO 5359 : 2014 AMD 2 2018 | Identical |
UNI EN ISO 5359 : 2015 | Identical |
NBN EN ISO 5359 : 2014 | Identical |
DIN EN ISO 5359:2015-02 | Identical |
BS EN ISO 5359 : 2014 | Identical |
I.S. EN ISO 5359:2014 | Identical |
ONORM EN ISO 5359 : 2018 | Identical |
ISO 5359:2014/Amd 1:2017 | Identical |
SN EN ISO 5359 : 2014 AMD 1 2018 | Identical |
NS EN ISO 5359 : 2014 AMD 1 2017 | Identical |
UNE-EN ISO 5359:2015/A1:2018 | Identical |
DIN EN ISO 5359:2018-05 | Identical |
BS EN ISO 5359:2014+A1:2017 | Identical |
EN ISO 1402:2009 | Rubber and plastics hoses and hose assemblies - Hydrostatic testing (ISO 1402:2009) |
ISO 5774:2016 | Plastics hoses — Textile-reinforced types for compressed-air applications — Specification |
ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
CGSB 24.2 : M86 | IDENTIFICATION OF MEDICAL GAS CONTAINERS, PIPELINES AND VALVES |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN ISO 14155:2011/AC:2011 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
EN ISO 1307:2008 | Rubber and plastics hoses - Hose sizes, minimum and maximum inside diameters, and tolerances on cut-to-length hoses (ISO 1307:2006) |
ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
CGA C 9 : 2013 | STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE |
IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
EN ISO 8033:2017 | Rubber and plastics hoses - Determination of adhesion between components (ISO 8033:2016) |
ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
ISO/IEC Guide 51:2014 | Safety aspects Guidelines for their inclusion in standards |
ISO 10524-3:2005 | Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
ISO 11197:2016 | Medical supply units |
EN 15908:2010 | Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
EN ISO 15001:2011 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
EN 1089-3:2011 | Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding |
CGA V 5 : 2008(R2013) | DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS) |
EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
ISO 7751:2016 | Rubber and plastics hoses and hose assemblies Ratios of proof and burst pressure to maximum working pressure |
AS 2896-2011 | Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems |
ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
ISO 9170-1:2017 | Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum |
EN ISO 9170-1:2008 | Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
AS 4484:2016 | Gas cylinders for industrial, scientific, medical and refrigerant use - Labelling and colour coding |
ISO 1402:2009 | Rubber and plastics hoses and hose assemblies Hydrostatic testing |
ISO 1307:2006 | Rubber and plastics hoses — Hose sizes, minimum and maximum inside diameters, and tolerances on cut-to-length hoses |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
ISO 18082:2014 | Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
ISO 8033:2016 | Rubber and plastics hoses Determination of adhesion between components |
ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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