EN 14931:2006

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing

This European Standard is applicable to the performance and safety requirements and their associated test methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as pressure chambers.

Druckkammern für Personen - Mehrpersonen-Druckkammersysteme für hyperbare Therapie - Leistung, sicherheitstechnische Anforderungen und Prüfung

Diese Norm gilt für die Leistungs  und sicherheitstechnischen Anforderungen und die zugehörigen Prüfverfahren für Mehrpersonen-Druckkammern, die für Drücke oberhalb des atmosphärischen Umgebungsdrucks ausgelegt sind und in medizinischen Einrichtungen für therapeutische Zwecke verwendet werden, im Folgenden als Druckkammern bezeichnet.

Chambres hyperbares à occupation humaine - Chambres hyperbares multiplaces à usage thérapeutique - Performances, exigences de sécurité et essais

Tlačne posode za humano uporabo (PVHO) – Večprostorski sistemi za hiperbarično terapijo – Lastnosti, varnostne zahteve in preskušanje

General Information

• Status: Published
• Publication Date: 31-May-2006
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CEN/TC 359 - Project Committee - Hyperbaric chambers
• Drafting Committee: CEN/TC 359 - Project Committee - Hyperbaric chambers
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 15-Jun-2022
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/342 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: hyperbaric chambers for medical purposes)
• Ref Project: SIST EN 14931:2006 - Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testingMHChambres hyperbares a occupation humaine - Chambres hyperbares multiplaces a usage thérapeutique - Performances, exigences de sécurité et essaisDruckkammern für Personen - Mehrpersonen-Druckkammersysteme für hyperbare Therapie - Leistung, sicherheitstechnische Anforderungen und PrüfungTa slovenski standard je istoveten z:EN 14931:2006SIST EN 14931:2006en,fr,de11.040.60ICS:SLOVENSKI
STANDARDSIST EN 14931:200601-september-2006

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14931June 2006ICS 11.040.60 English VersionPressure vessels for human occupancy (PVHO) - Multi-placepressure chamber systems for hyperbaric therapy -Performance, safety requirements and testingChambres hyperbares à occupation humaine - Chambreshyperbares multiplaces à usage thérapeutique -Performances, exigences de sécurité et essaisDruckkammern für Personen - Mehrpersonen-Druckkammersysteme für hyperbare Therapie - Leistung,sicherheitstechnische Anforderungen und PrüfungThis European Standard was approved by CEN on 27 April 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14931:2006: E

Adaptor set for compression chambers.25 A.1 General.25 A.2 Standard connections or adaptor set required for the interchangeability of compression chambers.25 A.3 Adaptor set female coupling (locking ring).26 A.4 Adaptor set male coupling (reducing ring).27 A.5 Basic dimensions for a treatment chamber to allow mating with a transport chamber.28 A.6 Basic dimensions for a transport chamber to allow mating with a treatment chamber.29 Annex B (informative)
Recommendations for medical devices used in hyperbaric chamber systems.30 B.1 General.30 B.2 Pressure.30 B.3 Oxygen.31 B.4 Electricity.32 B.5 Typical medical equipment which may be required for critical care.33 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC.36 Bibliography.39

Part 1: Terminal units for compressed medical gases and vacuum EN 739:1998, Low-pressure hose assemblies for use with medical gases EN 837-1, Pressure gauges
Part 1: Bourdon tube pressure gauges
Dimensions, metrology, requirements and testing EN 1041:1998, Information supplied by the manufacturer with medical devices EN 1865, Specifications for stretchers and other patient handling equipment used in road ambulances EN 12021, Respiratory protective devices
Compressed air for breathing apparatus EN 13348, Copper and copper alloys
Seamless, round copper tubes for medical gases or vacuum EN 13445-5, Unfired pressure vessels — Part 5: Inspection and testing EN ISO 6941, Textile fabrics
Burning behaviour
Measurement of flame spread properties of vertically oriented specimens (ISO 6941:2003) EN ISO 14971, Medical devices
Application of risk management to medical devices (ISO 14971:2000) EN ISO 15001, Anaesthetic and respiratory equipment
Compatibility with oxygen (ISO 15001:2003) ISO 6309:1987, Fire protection
Safety signs IEC 60364-7-710, Electrical installations of buildings
Part 7-710: Requirements for special installations or locations; Medical locations FMVSS 49 CFR 571 302, Flammability of interior materials 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 hyperbaric chamber system consists of a pressure chamber and its supporting equipment NOTE Supporting equipment is equipment needed to operate the pressure chamber, e.g. gas supply, control panel, and safety equipment. 3.2 main chamber/main lock part of the pressure chamber used for carrying out therapy
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