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
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
EN 14931:2006 (E) 2 Contents Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.5 4 Performance, safety requirements and testing.6 4.1 General.6 4.2 General requirements common to ante chamber and main chamber.7 4.3 Main chamber requirements.12 4.4 Ante chamber requirements.14 4.5 Control console.15 4.6 Compressed air supply system.18 4.7 Treatment gas supply.19 4.8 Communications.22 4.9 Emergency power supply.22 5 Operating instructions.23 6 Marking.24 Annex A (normative)
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
EN 14931:2006 (E) 3 Foreword This document (EN 14931:2006) has been prepared by CEN/BT/TF 127 “Hyperbaric therapy chambers”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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.
EN 14931:2006 (E) 4 Introduction Pressure chambers for therapeutic use are required for the administration of hyperbaric oxygen therapy and for the treatment of decompression illness. These chambers are made to allow the safe administration of hyperoxic gas mixtures at pressure while avoiding the risks of fire within the chamber and of uncontrolled compression or decompression. They need to allow all levels of patient care up to intensive care with all the necessary equipment and provide a safe working environment for patient carers. Standards on ergonomics for the design of pressure chambers for therapeutic use are not available. Nevertheless guidance for the application of ergonomics standards is given in the bibliography. Chambers providing exclusively for hyperbaric oxygen therapy operate typically with a maximum operational pressure of 200 kPa (2 bar) above atmospheric pressure. Pressure chambers providing treatment for decompression illness have a maximum operating pressure of 500 kPa (5 bar) or more. Treatment times in the chamber are typically 2 h to 3 h for hyperbaric oxygen treatments while standard treatment for decompression illness may last 8,5 h or more. Atmospheric conditions within the chamber need to be comfortable and, in particular, oxygen levels require control in order to avoid hypoxia, oxygen toxicity and undue risk of fire.
EN 14931:2006 (E) 5 1 Scope 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. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 737-1:1998, Medical gas pipeline systems
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
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
EN 14931:2006 (E) 6 3.3 ante chamber/entry lock part of the pressure chamber used for locking in and out persons and equipment 3.4 relative (gauge) pressure pressure defined as p - pamb, where pamb is the ambient pressure. Thus the gauge pressure is positive or negative according as p is larger or smaller than pamb respectively [ISO 31-3:1992, 3-15.1] NOTE All pressures in this European Standard are expressed as relative (gauge) pressures. The Directive defines: "'Pressure means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value." 3.5 maximum allowable pressure/design pressure (MAP) maximum pressure for which the equipment is designed, as specified by the manufacturer 3.6 test pressure excess pressure to which components or one component are subjected for test purposes NOTE Test pressure is referred as "hydrostatic test pressure" in Directive 97/23/EC. 3.7 maximum operational pressure maximum pressure under which the equipment is used for therapeutic purposes NOTE The operational pressure is referred as "pressure" in Directive 97/23/EC. 3.8 single fault condition condition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present 3.9 treatment gas medical gas or mixture of gases administered to the patient for treatment 4 Performance, safety requirements and testing 4.1 General As medical devices, hyperbaric chamber systems shall be in accordance with the Directive 93/42/EC on medical devices. Pressurised components within such systems shall be in accordance with the Directive 97/23/EC on pressure equipment. Hyperbaric pressure chamber systems shall, when installed, commissioned, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with EN ISO 14971 in regard to their intended application, in normal condition and in single fault condition. Hyperbaric chamber systems and components or parts thereof, using materials or having forms of construction different from those detailed in this European Standard, shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained. Such evidence shall be provided by the manufacturer. NOTE Evidence will be provided to e.g. a Notified Body during EC conformity assessment and on request to the competent authority. An example of risk analysis is given in the European Code of Good Practice for Hyperbaric Oxygen Therapy.
EN 14931:2006 (E) 7 4.2 General requirements common to ante chamber and main chamber 4.2.1
Pressure chambers shall comprise at least two compartments an ante chamber and a main chamber. Each compartment including supply lock shall be designed for a test pressure according to Table 1. Testing: Shall be according to EN 13445-5. 4.2.2
The gas used to pressurise the chamber shall never contain more than 21 % oxygen. 4.2.3
Pressure chambers shall be designed such that an operational pressure of at least 200 kPa (2 bar) can be reached and maintained. 4.2.4
The relationship between test pressure, maximum allowable pressure/design pressure, maximum operational pressure and atmospheric pressure is specified in Table 1. Table 1 — Relationship between test pressure, maximum allowable pressure/design pressure, maximum operational pressure and atmospheric pressure Pressure Value
Test pressure 1,43 MAP Maximum allowable pressure/Design pressure 1 MAP Maximum operational pressure 0,91 MAP Atmospheric pressure 0 kPa (0 bar)
Testing: Verification as to whether the values stipulated for the ante chamber and the main chamber are complied with. 4.2.5 Breathing units 18.104.22.168
For each person to be accommodated according to 4.3.3 and 4.4.1 a breathing unit for treatment gas shall be available independent from chamber atmosphere. Testing: Checking by inspection of the installation as to whether an adequate number of breathing units are provided. 22.214.171.124
The treatment gas can be delivered by a free flow system or by a demand system or by a system for the artificial ventilation of the lung. Each individual breathing unit shall be suitable for operation in a hyperbaric chamber system (for information refer to Annex B) It shall be equipped with a system able to completely discharge exhaled gas / ventilation gas out of the chamber (overboard dumping).
EN 14931:2006 (E) 8 Testing: Checking by inspection of the piping system as to whether it is possible for the gas to be passed out from the chamber. 126.96.36.199
If the treatment gas is supplied via a demand system then, with a chamber pressure of 150 kPa (1,5 bar) and a minimum breathing volume of 22,5 l/min (1,5 l/breath x 15 breaths/minute), measured at the pressure within the chamber, the pressure drop to open inhalation and exhalation valves shall not be higher than - 0,3 kPa (- 3 mbar) and + 0,3 kPa (+ 3 mbar), respectively. The maximum pressure in the mask shall not exceed + 0,5 kPa (+ 5 mbar) and the minimum pressure in the mask shall not be less than - 0,5 kPa (- 5 mbar). Testing: Checking of manufacturers' certificate as to compliance of the source for treatment gas with the requirements; 188.8.131.52 operational test of each breathing unit under pressure. Means to regulate the flow in breathing systems other than demand valve systems shall be provided. Testing: Operational test of each breathing unit under pressure. 4.2.6
Pressure chambers shall be equipped with safety devices which shall not respond until the maximum operational pressure to be maintained according to 4.2.4 has been exceeded and shall close before the pressure drops below this maximum operational pressure. The safety devices shall be mounted to the pressure chamber in such a way that they are protected from mechanical damage and accidental operation. The opening in the pressure chamber through which the air can flow off to the safety device is to be protected such that it cannot be sealed off unintentionally. With the maximum possible flow of air supplied as the worst single fault condition, the chamber pressure shall not exceed the maximum allowable pressure according to 4.2.4 by more than 10 %, once the safety device has responded. Testing: After completion of the installation, on site. 4.2.7
The main chamber and the ante chamber shall both have separate controls and pipework for compression, decompression, ventilation and treatment gas. Testing: Testing of the control functions of the ante chamber and of the main chamber. Interaction between main chamber and ante chamber shall not occur.
EN 14931:2006 (E) 9 4.2.8
Seating shall be ergonomic and prevent person contact with cold, hot or sharp materials. Seating shall provide each person with a seat width of at least 0,5 m and a seat depth of at least 0,4 m. If upholstery is used it shall be compatible with hyperbaric conditions. Testing: Inspection of seats and upholstery, measuring of seat area. 4.2.9
Patient access through door openings shall have a minimum height of 1,55 m and a minimum width of 0,7 m and shall allow the passage of a patient lying flat on a stretcher with the dimensions according to EN 1865. Other ante chamber or main chamber door openings shall have a minimum height of 1,1 m and a minimum width of 0,6 m, if they are rectangular, and a minimum inside diameter of 0,6 m, if they are round. Testing: Measuring of door openings. 4.2.10
All closures and openings (e.g. doors, locks, hatches) not intrinsically safe shall be equipped with an automatic or manual device enabling the user easily to ascertain that the opening will not present any hazard. Furthermore, where the opening can be operated quickly, the pressure equipment shall be intrinsically safe (e.g. doors closing with the pressure and manually operated) or shall be fitted with a device to prevent it being opened whenever the pressure presents a hazard. Testing: Functional test. 4.2.11
If the pressure chamber is intended to be fitted with a bayonet flange connection for transport chambers, this shall be designed in accordance with Annex A. 4.2.12
There shall be at least one observation window in each compartment. The window/s shall be arranged in such a way that all seats in the chamber can be observed from the outside. The panes shall be made of suitable material. Currently acrylic is suitable following the ASME PVHO specifications, glass is not allowed. Testing: Inspection of panes and checking as to whether a certificate as defined by the Pressure Equipment Directive 97/23/EC is on hand. 4.2.13
To allow visual surveillance of patients, the lighting in ante chambers and main chambers shall provide a minimum illumination of 300 lx at the seating level. Means shall be provided to bring the lighting level down to 10 lx. Means shall be provided to provide a focussed illumination of at least 500 lx.
EN 14931:2006 (E) 10 An emergency lighting independent of mains power supply shall be available with a minimum illumination of 90 lx to proceed or end the therapy. Testing: By measurement (see ISO 8995 for information). 4.2.14
If remote-controlled valves are used, means shall be provided to ensure continuous operation of the pressure chamber system in a single fault condition using at least a manual backup. NOTE Single fault condition is a loss of either mains electrical power or pneumatic power or computer control. Testing: Evidence shall be provided by the manufacturer. 4.2.15
In any gas or liquid filled connection to the interior of the pressure chamber a shutoff device shall be fitted to the pressure chamber such that in the event of the line bursting the pressure chamber will neither be compressed nor decompressed. The shutoff devices shall be easily accessible. This shutoff device is not required for short metal pipework ,which is mechanically protected up to the first valve. Testing: Visual inspection and operational test. 4.2.16
If means are provided inside the chamber to stop an increase or decrease of pressure or to change from treatment gas to air, they shall be protected against unintentional use. The overall control of the pressure chamber system shall be at all times under the control of an external operator. Testing: Visual inspection and function testing. 4.2.17
Within each compartment there shall be an internal pressure measuring and indicating device. The internal pressure measuring device shall be accurate to 1 % of full scale deflection. It shall be possible to calibrate it. Testing: Manufacturer's proof. 4.2.18
Structural measures shall be taken to prevent the development of noise exceeding an evaluation level of 70 dB(A) inside the pressure chamber at head level of seated persons under isobaric pressure conditions with ventilation according to the maximum number of persons.
EN 14931:2006 (E) 11 A noise level of 90 dB(A) shall not be exceeded during compression or decompression. Testing: Measurement under most stressful operational conditions as specified by the manufacturer. NOTE The microphone should be arranged in the pressure chamber centre at a seated person's head level. 4.2.19
The following fire protection measures shall be taken: a) The use of combustible material for pressure chamber equipment should be avoided or if impossible, shall be kept to a minimum. Materials covering large areas, e.g. expanded plastic coverings and linings, shall be flame-retardant. Combustible materials shall comply with EN ISO 6941, FMVSS 49 CFR 571 302 or equivalent standards. Electrical and heating equipment shall be protected to prevent spark generation and overheating during normal operation and in case of single fault condition. NOTE 1 Criteria for the selection of non-metallic materials are given in EN ISO 15001, NFPA 99 and NFPA 53. b) The pressure chamber shall be equipped with a fire-extinguishing system in all compartments. NOTE 2 Criteria for the design and the performance of the fire-extinguishing system are given in NFPA 99 and DIN 13256-3. NOTE 3 The fire-fighting system consists of a fire-extinguishing system, means to switch over from oxygen to air, and an alarm system activator. A separate European Standard for fire extinguishing systems in pressure chambers is in preparation. c) Activation shall be possible by hand inside and outside the chamber. d) Additionally, a fire extinguisher designed for manual use under hyperbaric conditions shall be provided in each lock. e) Inside the pressure chamber readily ignitable materials, combustible liquids, gases and vapours and spark-generating devices are not permitted. In the immediate vicinity of the entrance to the pressure chamber and inside the chamber a prohibition sign according to ISO 6309:1987F, No. 19 is to be posted in a prominent position. f) It shall be possible for the chamber operator to shift from treatment gas to air on the control panel. g) An alternative source of breathing air shall be available outside the chamber for use by personnel in the event that the air in the vicinity of the chamber is not breathable. Testing: h) Checking of certificates in respect of fire-retardant properties according to EN ISO 6941,
FMVSS 49 CFR 571 302 or equivalent testing procedures. i) Operational test of the fire-extinguishing appliance. In the case of sprinkler or similar systems proof of testing at maximum operational pressure is required in connection with the system as well as of an operational test on the spot with reduced extinguishing period and appropriate protective measures to prevent flooding / spraying of the pressure chamber with water.
NOTE An example of a test method is given in DIN 13256-3. j) Checking of whether the 1 prohibition signs according to ISO 6309 are posted such as to be in full view. k) Checking of whether at the entrance to the pressure chamber notices are provided indicating that pressure-sensitive, combustible or readily ignitable objects are not permitted to be introduced into the chamber.
EN 14931:2006 (E) 12 4.2.20
It shall be possible for the pressure chamber and its equipment, including breathing units and underfloor and overceiling spaces, if any, to be easily cleaned and disinfected. The manufacturers shall provide instructions for cleaning and disinfection. Testing: Visual inspection. 4.2.21
Electrical installation of the pressure chamber system outside the pressure chamber shall conform to
IEC 60364-7-710. Electrical equipment and installation inside the pressure chamber, including lighting, shall conform to the application category specified by IEC 60364-7-710 for such spaces, depending on the kind of medical use and medical equipment, but at least to application category 1. The voltage of the installations in the pressure chamber can be allowed to exceed 42 V only if the installations are of a construction proven to eliminate the hazard of this higher voltage. The interior floor shall be antistatic. NOTE For patient connected medical electrical equipment see Annex B. Testing: Checking of whether the requirements according to IEC 60364-7-710 for spaces of the respective application category are complied with. 4.2.22
Chamber paint shall be compatible with hyperbaric conditions. 4.3 Main chamber requirements 4.3.1
The maximum compression rate shall be greater than 80 kPa/min (0,8 bar/min) and not exceed 300 kPa/min (3,0 bar/min). Testing: Checking as to whether the values are complied with. 4.3.2
During normal operation it shall be possible for the pressure in the main chamber to be reduced from 40 kPa (0,4 bar) to 20 kPa (0,2 bar) within 1 min ± 20 s. Slower decompression rate during operation shall be possible. The main chamber shall be provided with a separate emergency discharge valve marked accordingly and sealed and permitting the pressure in the main chamber to be reduced from 200 kPa (2 bar) to ambient pressure within a period not exceeding 2 min. The location of the emergency discharge shall be defined using risk management procedure in accordance with
EN ISO 14971 manufacturer in cooperation with the operator. Testing: Checking as to whether the values stipulated are complied with.
EN 14931:2006 (E) 13 4.3.3
The number of occupants allowed in the main chamber is to be stated on a plate prominently and permanently fixed above the entrance. Testing: Inspection. 4.3.4
For each person to be accommodated, a seat or stretcher shall be provided and, after deduction for interior equipment, a volume within the chamber of at least 1 m³. Testing: Checking of number of seats by inspection; checking of space within the chamber on the basis of design documents. 4.3.5
The main chamber shall be equipped with means ensuring
ventilation to maintain the chamber atmosphere within specified limits given in Table 2. Means shall be provided so that during ventilation the pressure does not vary by more than ±5 %. Table 2 — Values to be maintained by ventilation Oxygen ≤ 23,5 % a Carbon dioxide < 0,5 kPa (absolute pressure) Impurities organic compounds < 0,5 mg/m3
Relative humidity 40 % to 60 % Values are given in concentration in dry gas. a
The oxygen content in the chamber atmosphere shall at no place in the chamber exceed 23,5 %.
Testing: Operational test. 4.3.6
It shall be possible to position at least one stretcher with the minimal dimensions according to EN 1865. Any patient on a stretcher should be accessible from both sides and the space shall be sufficient for resuscitation procedures. Testing: Inspection. 4.3.7