Bsi bs en 16081 2011 + a1 2013

BS EN 16081:2011+A1:2013 BS EN 16081:2011 BSI Standards Publication Hyperbaric chambers — Specific requirements for fire extinguishing systems — Performance, installation and testing BS EN 16081:2011+A1:2013 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 16081:2011+A1:2013 It supersedes BS EN 16081:2011, which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by  The UK participation in its preparation was entrusted to Technical Committee CH/100/-/1, Multi-occupancy hyperbaric chambers for use as medical devices A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2013 Published by BSI Standards Limited 2013 ISBN 978 580 84509 ICS 11.040.60; 13.220.20 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2011 Amendments/corrigenda issued since publication Date Text affected 30 September 2013 Implementation of CEN amendment A1:2013 EUROPEAN STANDARD EN 16081:2011+A1 NORME EUROPÉENNE EUROPÄISCHE NORM September 2013 ICS 13.220.20 Supersedes EN 16081:2011 English Version Hyperbaric chambers - Specific requirements for fire extinguishing systems - Performance, installation and testing Chambres hyperbares - Exigences spécifiques relatives aux systèmes de lutte contre l'incendie - Performances, installation et essais Druckkammern - Spezifische Anforderungen an Feuerlöschsysteme - Leistung, Montage und Prüfung This European Standard was approved by CEN on July 2011 and includes Amendment approved by CEN on 13 August 2013 CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 16081:2011+A1:2013: E BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Contents Page Foreword Scope Normative references Terms and definitions 4 Specific hazards regarding fire risks Performance and requirements Test requirements for fire extinguishing systems .6 Annex A (informative) Dummy 10 Annex B (informative) Operation of fire extinguishing systems 11 B.1 Risk analysis and procedures 11 B.2 Elements of fire fighting 12 B.3 Prevention 12 B.3.1 Materials 12 B.3.2 Prohibited materials 13 B.3.3 Education and training 14 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices" 15 Bibliography 16 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Foreword This document (EN 16081:2011+A1:2013) has been prepared by Technical Committee CEN/TC 359 “Project Committee - Hyperbaric 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 March 2014, and conflicting national standards shall be withdrawn at the latest by March 2014 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights This document supersedes EN 16081:2011 This document includes Amendment 1, approved by CEN on 2013-08-13 The start and finish of text introduced or altered by amendment is indicated in the text by tags !" 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 organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Scope This European Standard is applicable to the performance and safety requirements of fire extinguishing systems and their associated test methods for multi-place chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as chambers 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 14931:2006, Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing Terms and definitions For the purposes of this document, the following terms and definitions apply: 3.1 fire extinguishing system system for active deployment of extinguishing medium inside the chamber in order to extinguish fire 3.2 extinguishing medium liquid or gas used to extinguish fire 3.3 nozzle mechanical device used to ensure dispersion of extinguishing medium inside the chamber with certain characteristics Specific hazards regarding fire risks A fire, as a physical phenomenon, is significantly influenced by the ambient pressure, the partial pressure of oxygen and the confined space of the hyperbaric chamber The rate of combustion will be directly related to ambient pressure and the oxygen level In a hyperbaric environment with increased oxygen partial pressure, even materials thought to be non-combustible will burn fiercely Owing to the confined space in the chamber, a fire would cause a sudden increase of temperature and high concentration of toxic gases and smoke If such a fire occurs, it shall be dealt with quickly and all personnel and patients shall be evacuated from the chamber People suffering from breathing difficulties and burns shall be cared for (see Annex B) Performance and requirements 5.1 Fire extinguishing systems in hyperbaric chambers shall produce a specified extinguishing performance as stated in Clause 5.2 Fire extinguishing systems shall suit the chamber’s maximum operational pressure They shall fully protect all chamber compartments for human occupancy BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) 5.3 The fire extinguishing system shall be installed in such a way that the risk of physical injury to persons inside the chamber is as low as possible 5.4 Fire extinguishing systems shall have a manual release Independent activation shall be possible from inside and outside the chamber The release shall be easily accessible and protected against unintentional activation (e.g safety button) For operation, see EN 14931:2006, 4.5.1 An additional automatic release is permitted if its suitability is proven for hyperbaric conditions up to the chamber's maximum operational pressure and documented 5.5 With both an automatic and manual release, a warning signal shall be heard at the control console This warning signal may be temporarily muted, but there shall be no possibility to switch it off as long as the fire system is active 5.6 The extinguishing nozzles shall be installed in such a way that the required extinguishing effect is ensured for any sitting and lying place inside the chamber A lying place is to be considered as minimum three sitting places in one line NOTE The nozzles arrangement is stipulated by the manufacturer of the fire extinguishing system He decides where and how many nozzles in accordance with seats or stretchers are to be placed Other areas shall be covered in the seating height by the equivalent of at least 50% of the required extinguishing medium flow specified per seat (see 6.2.14) This medium flow shall be delivered from nozzles of the same characteristic as in the test 5.7 Pipes and hoses containing the extinguishing medium shall be made of suitable material concerning pressure and corrosion For other pipes and hoses, see EN 14931:2006, 4.7.4 For shut off devices, see EN 14931:2006, 4.2.15 5.8 Pipes and hoses of the fire extinguishing system shall be marked according to the medium and its function Actuators (e.g valves, press buttons and manual releases) shall be marked in such a way that they are distinguished from all other systems For installation of pipes, see EN 14931:2006, 4.7.7 5.9 The extinguishing medium tank shall be suitable for the intended pressure and protected against pressure exceeding the maximum allowable design pressure The material of the tank shall be suitable for the extinguishing medium or shall be adequately protected against corrosion The extinguishing medium supply tank shall be equipped with a controllable level indicator and pressure gauge The control console of the chamber shall indicate at least the status of the fire-extinguishing system (filling level, supply pressure) 5.10 Conveying of the extinguishing medium shall be done by pump system (positive-displacement pumps) or a pressure tank system each exclusive to the extinguishing system 5.11 Within s following the release of the fire extinguishing system the pressure build-up in the fire extinguishing system shall be realised and the extinguishing medium shall come out in the chamber 5.12 The extinguishing medium flow shall automatically switch off before the extinguishing medium is exhausted to prevent any gas or liquid other than the extinguishing medium entering the compartment Manual shutdown of the fire extinguishing system as well as repeated switching on by the chamber operator (outside) shall be possible at any given time It shall be impossible to manually switch off the fire extinguishing system from inside the chamber BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) 5.13 The required supply of extinguishing medium shall be calculated to ensure at least of extinguishing medium flow taking into account 5.6 and 6.2.14 5.14 If extinguishing medium other than water of drinking water quality or distilled water is used, its safety to health shall be proven without additional (e.g gas mask) measures 5.15 Installation of the fire extinguishing system with all its components shall be protected against freezing 5.16 Pressure vessels shall be designed, examined and marked according to the applicable standard 5.17 Should an electric power supply be necessary for operating the fire extinguishing system, it shall be connected to an uninterruptible power supply (UPS) as a back-up 5.18 Fire extinguishing systems shall be labelled with a permanently readable and well visible type plate containing at least the following details:  name or trade name and address of the manufacturer;  type;  working pressure;  date of manufacturing and serial number;  test interval;  name of the organisation which performed the concept test 5.19 Operating instructions of the fire extinguishing system shall be provided by the manufacturer according to EN 14931:2006, Clause The manufacturer will propose a maintenance programme comprising an annual test in order to verify the efficiency of the fire extinguishing system and in case of a wet test a purge of each part (nozzles included) of the fire extinguishing system Test requirements for fire extinguishing systems 6.1 A concept test consists of a hot test and a wet test A third party certification is required for the concept test For each type of fire-extinguishing system and parameters of the chamber, a fire test series (hot test) must be carried out in a test chamber according to specifications given in 6.2 under consideration of 6.3.4 The wet test is part of a functioning and acceptance test of the installation of the fire extinguishing system to show that the items according to 6.3.2 are fulfilled, as well as the extinguishing means capacity and performance and the spray pattern of each system manufactured (acceptance test at the final installation at least for the first system) The concept test will be certified by a third party certification organisation having the experience (qualified by education and training) The documentation of the test shall include at least: time from activation to start of deployment as well as the deployment time, supply pressure, leakage test of system, releasing points, direction and location of nozzles, function of nozzles and comparison with design documents 6.2 6.2.1 Parameters and conditions of fire extinguishing tests (hot test) Tests of fire extinguishing systems shall be performed under the following conditions: BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E)  test at 200 kPa (2,0 bar gauge) pressure with 21 vol.-% oxygen (O2);  tests at 150 kPa (1,5 bar gauge) pressure with 30 vol.-% O2;  test at max working pressure of the chamber with 21 vol.-% O2 6.2.2 For simulation of persons, dressed dummies that are inflammable and impenetrable to the extinguishing medium must be used 6.2.3 For each extinguishing test at least two torso dummies shall be used The dummies shall be the size of a normal adult (see Annex A) and be positioned on seats next to each other with a distance of 15 cm between the arms 6.2.4 During the extinguishing test, the dummies shall be put on closed seat shells with the seatback made of steel plate, width and depth according to EN 14931:2006, 4.2.8 and a seat height of ≥≥50 cm in a seated position 6.2.5 For each extinguishing test each dummy shall be dry and is to be dressed in dry clothing as follows:  short sleeve cotton undershirt;  short cotton underwear;  mixed fabric shirt with long sleeves (max 70% cotton);  pair of cotton trousers (long);  hair decoy out of lambskin strips, about 10 cm wide, normal hairline at forehead and neck 6.2.6 Commonly used, fast reacting thermo elements (TE) are to be fixed on each dummy in the following positions:  1TE on the dummy, front side, just above the waistband;  1TE on the dummy, front side, shoulder area;  1TE on the head;  1TE 30 cm in front of face;  1TE 60 cm above the head 6.2.7 The thermo elements are to be fixed on the dummy’s bodies in such a way that no falsifying heat influence of the thermo elements can occur 6.2.8 Suitable thermo elements that have been checked for proper function and signs of thermal damage are to be used for the fire extinguishing tests 6.2.9 The arrangement of extinguishing nozzles in relation to the dummy in this test shall reflect the locations and distances between those elements in the chamber to be delivered The arrangement of the nozzles shall be included in the test records 6.2.10 The fire shall be ignited on one dummy, front side, just above the waistband An electric resistance wire of smallest possible weight is to be used as the ignition source BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) 6.2.11 The fire extinguishing system must be released when the flame reaches the upper line of the shoulder level The test is valid only in situations when at least two thermoelements indicate an increase of temperature of at least 100 °C A video film of this part of the test shall be included in the records NOTE This video film should include time (in s), pressure (in bar gauge) and oxygen content (in vol.-%) of the test performed 6.2.12 During the extinguishing process chamber temperatures, temperatures of thermo elements and chamber pressure are to be recorded on a time graph Content of O2 in the chamber atmosphere is to be measured and recorded before and after a fire test Furthermore, the extinguishing behaviour is to be recorded by a video camera This video film shall also include the condition of the dummies and clothing before and after the test 6.2.13 The fire extinguishing system fulfils the requirements if:  the chamber pressure has dropped to the initial level and temperatures at all temperature measuring points are below 50 °C in ≤ 20 s after activation of the fire extinguishing system and  the fire is out after ≤ 40 s after activation of the fire extinguishing system If the requirements are not fulfilled at any of the tests, the fire extinguishing system shall be modified and all tests defined in 6.2.1 shall be repeated 6.2.14 Based on the test conditions described in 6.2.1 taking into account requirements described in 6.2.13 the extinguishing medium flow per seat is to be calculated for every test condition NOTE To calculate the extinguishing medium flow per seat the following values are needed:  Volume of extinguishing medium displaced during the test (V in l);  Time from activation of the system until fire is out (t in s);  Number of seats in the test (n);  Extinguishing medium flow per seat = V(t × n)−1 in l × s−1 From those calculated flows the highest value is chosen to fulfil the minimum requirement for extinguishing medium flow per seat 6.2.15 The effectiveness of a fire extinguishing system can only be recognised if the fire extinguishing tests were carried out under the supervision of a third party certification organisation and an appropriate test certificate was issued The test certificate shall include as a minimum:  name or trade name of the fire extinguishing system;  name and address of the manufacturer;  type of the extinguishing medium;  maximum working and test pressure of the fire extinguishing system; BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E)  maximum working pressure of the hyperbaric chamber(s);  date of the type test;  periodic inspection interval according to operating instructions 6.3 On site acceptance test 6.3.1 The on site acceptance test must be carried out by a third party certification organisation who performed the hot test as part of the concept test Each fire extinguishing system is to be tested (wet test) by a third party certification organisation who performed the hot test as part of the concept test or the manufacturer certified according to MDD Annex II as well as concerning the transferability of results of the hot tests to the individual chamber system All test results must be certified accordingly 6.3.2 It must be proven:  that all pressure vessel certificates are available;  that the system was installed according to a design approved by a third party certification organisation or the manufacturer certified according to MDD Annex II;  that requirements according to chapter 5, 6.2.9 and 6.2.14 are fulfilled;  that a pressure test, tightness test and cleaning of pipe work were carried out;  that safety devices exist and are properly adjusted;  that a pressure supply system is properly installed and secured;  that the pipe work is protected according to EN 14931:2006, 4.7.7;  that the fire extinguishing system, if required is connected to an adequate uninterruptable power supply;  check of markings;  check of operation manual 6.3.3 The wet test shall be performed at 100 kPa (1 bar gauge) and shall include at least: time from activation to start of deployment as well as the deployment time, supply pressure, leakage test of system, function of all releasing points, and the performance of nozzles compared with design documents 6.3.4 Geometry and built in equipment of the chamber as well as direction and location of nozzles are to be compared with conditions in the chamber in which the hot test was conducted 6.3.5 A wet test shall be done in each compartment of the chamber In connection with the acceptance test and during the recurring tests of the fire extinguishing system the free flow and the adjustment of the nozzles shall be checked BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Annex A (informative) Dummy Dimensions in millimetres Figure A.1 — Dimensions of a Dummy 10 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Annex B (informative) Operation of fire extinguishing systems B.1 Risk analysis and procedures For every medical hyperbaric installation, a risk analysis for fire hazards should be conducted taking into accounts specific hyperbaric conditions Fire, as a physical phenomenon is significantly influenced by the ambient pressure, the partial pressure of oxygen and the confined space of the hyperbaric chamber The rate of combustion will be directly related to ambient pressure and the oxygen level In a hyperbaric environment with increased oxygen partial pressure, even materials thought to be non-combustible will burn fiercely Owing to the confined space in the chamber, a fire could cause a sudden increase of temperature, pressure and high concentration of toxic gases and smoke If such a fire occurs, it must be dealt with quickly and all personnel and patients should be evacuated from the chamber People suffering from breathing difficulties, burns and signs of decompression illness must be cared for This means that preventive measures and planning of a fire incident should include the building where the chamber is located as well as local emergency response teams In any risk analysis the following items should be included as fire hazards:  electrical installations;  electrostatic and mechanical sparks;  sealing of the breathing systems;  overheating of machinery in the chamber;  environment of the chamber atmosphere;  clothing of attendants and patients;  medical equipment brought into the chamber;  all materials and substances brought into the chamber With regard to fire prevention, the standard operating procedures should include ways and means for:  controlling the oxygen level of the chamber atmosphere;  proper sealing of the breathing masks and hoods;  preventing combustible material being brought into the chamber The emergency procedures should include ways and means to deal with:  high oxygen level in the chamber atmosphere;  fire in the hyperbaric chamber;  fire in the hyperbaric facility 11 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) B.2 Elements of fire fighting Fighting with fire in the medical hyperbaric chamber includes: a) detection of fire; b) alarm; c) fire extinguishing system; d) emergency decompression; e) evacuation 1) Detection of fire In addition to human surveillance, there are different technical methods to detect a fire For example, infrared (IR) and/or ultraviolet (UV) spectral analysers that detect open flames and or temperature 2) Alarm Alarming both chamber personnel and rescue/fire fighting teams is an essential part of fighting with fire The alarm should not be so loud that it prevents communication and it should not be possible to unintentionally turn off or mute the system 3) Fire extinguishing system In addition to the fire extinguishing system in the chamber, as presented in this European Standard, and handheld extinguishers, as mentioned in EN 14931, other measures could also be considered such as; manually operated fire-extinguishing hoses and blankets 4) Emergency decompression In case of fire, the pressure of the chamber should be lowered to reduce the partial pressure of oxygen, reduce the temperature and evacuate persons from inside the chamber A fast decompression is a risk for those in the chamber, but a fire could be a more imminent danger so the decompression should therefore be performed even if it means an increased risk for decompression illness 5) Evacuation Following a fire in the chamber, a rapid evacuation of chamber and surrounding areas should be performed to diminish the exposure to high temperature, flames and toxic fumes The organisation of evacuation should include availability of treatment facilities for all types of trauma, including hyperbaric treatment for recompression of victims with decompression illness B.3 Prevention B.3.1 Materials The rate of combustion of any material in a hyperbaric chamber will be directly related to ambient pressure and the oxygen level and even materials thought to be 'non-combustible' can burn very quickly in an oxygenenriched environment For any material brought into the chamber the risk of fire due to material flammability should be assessed The amount of flammable material that could be brought into the chamber should be minimised 12 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) B.3.2 Prohibited materials Materials to be prohibited in a hyperbaric chamber (Reference: European Code of Good Practice for Hyperbaric Oxygen Therapy): Each and every item added to the hyperbaric environment posses a potential risk which should be assessed prior to its approval All approved items taken inside the hyperbaric chamber should be assessed for their necessity The following items comprise a non-exhaustive listing of items and materials that should be either prohibited or severely limited inside the chamber The letter(s) following each item indicates the general reason for prohibiting it, the coding is shown below C possibility of damaging the fabric of the chamber D contamination of the environment E explosion risk F fire source (including static charges) or a combustible substance L could be broken or damaged by pressure M will possibly cause a mess P affects ability of occupant LISTING (in alphabetical order):  Adhesives (F)  Aerosols (D, E, F)  Aftershave (D, F)  Alcohol (D, F, P)  Batteries with unprotected leads (F)  Chemical cleaners, e.g trichlorethylene, „Freon“, etc (D)  Cigarettes, cigars, tobacco of all kinds (F, M)  Cleansing powder (C, F, P)  Clothing, bedding included blankets, sheets, pillows, mattresses, etc (F)  Drugs, non prescribed (P)  Electrical equipment including tape recorders, radios, etc (F)  Explosives (F)  Glass thermometers, including batteries containing mercury (C, D, P)  Ink pens (M) 13 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E)  Lighters, matches (F)  Newspaper (F)  Non-diving watches (L, M)  Petroleum based lubricants, grease, fluids (F)  Sugar and fine powders and other flammable food stuffs (E, F)  Thermos flasks (L, P) NOTE It is important to be aware that the clothing of occupants entering the chamber and bedding constitute an additional hazard as it may be either, synthetic, wool, contaminated or containing prohibited items 100% cotton or other hyperbaric compatible materials should be used B.3.3 Education and training Primary education of staff should include theory and practical training regarding fire in hyperbaric environment In addition, a follow-up training on a yearly basis should include practical training including actions to be performed if the oxygen concentration in the chamber increases, use of the fire fighting system, emergency decompression and evacuation of chamber and hyperbaric facility Each new patient needs to be given a full explanation with a printed support on the planned and the procedures in the chamber and especially on the safety precautions to be respected In addition, to reduce dependency on the human factors (“force of habit”), automatic messages regarding safety rules before each compression repeating safety rules are recommended 14 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this Essential Requirements (ERs) EN of Directive 93/42/EEC 5.8, 5.16 9.1 5.3 9.2 Qualifying remarks/Notes 5.1 to 5.2, 5.4 to 5.6, 5.10 to 9.3 5.13, 6.2, 6.3 5.16 12.7.1 5.17 12.7.4 5.9 12.8.1 5.8 13.1 Marking partly addressed to use device safely 5.18 13.3 a) partly covered The part of 13.3 a) relating to the authorised representative is not addressed 5.19 13.6 d) WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard." 15 BS EN 16081:2011+A1:2013 EN 16081:2011+A1:2013 (E) EN 16081:2011+A1:2013 (E) Bibliography [1] NFPA 99 - National Fire Protection Association - Health Care Facilities - Chap 20 Hyperbaric Facilities Ed 2005 [2] European Code of Good Practice for Hyperbaric Oxygen Therapy", European Journal of Underwater and Hyperbaric Medicine, Volume 5, Supplement 1, December 2004, ISSN:1605-9204 [3] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p 143 16 This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products are published by BSI Standards Limited About us Revisions We bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions Our British Standards and other publications are updated by amendment or revision The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process Organizations of all sizes and across all sectors choose standards to help them achieve their goals Information on standards We can provide you with 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