01075895 PDF BRITISH STANDARD BS EN 60601 2 9 1997 BS 5724 2 9 1997 IEC 601 2 9 1996 Medical electrical equipment — Part 2 Particular requirements for safety — Section 2 9 Specification for patient co[.]
BRITISH STANDARD Medical electrical equipment — Part 2: Particular requirements for safety — Section 2.9 Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors The European Standard EN 60601-2-9:1996, including Corrigendum December 1996, has the status of a British Standard ICS 11.040.50; 17.240 BS EN 60601-2-9:1997 BS 5724-2.9: 1997 IEC 601-2-9: 1996 BS EN 60601-2-9:1997 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/83, Dosemeters (Medical), upon which the following bodies were represented: British Measurement and Testing Association College of Radiographers Department of Health Institute of Physics and Engineering in Medicine and Biology National Physical Laboratory Royal College of Radiologists This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 June 1997 © BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference: CH/83 Draft for comment: 95/561704 DC ISBN 580 27645 Amendments issued since publication Amd No Date Comments BS EN 60601-2-9:1997 Contents Committees responsible National foreword Foreword Text of EN 60601-2-9 List of references © BSI 09-1999 Page Inside front cover ii Inside back cover i BS EN 60601-2-9:1997 National foreword This British Standard has been prepared by Technical Committee CH/83 It is the English language version of EN 60601-2-9:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors, including Corrigendum December 1996, published by the European Committee for Electrotechnical Standardization (CENELEC) It is identical with IEC 601-2-9:1996 published by the International Electrotechnical Commission (IEC) It supersedes BS 5724-2.9:1988 which is withdrawn Cross-references Publication referred to Corresponding British Standard IEC 601-1:1998 BS 5724-1:1989 General requirements for safety IEC 601-1:1988 Amendment 1:1991 Amendment to BS 5724-1:1989 General requirements for safety IEC 601-1:1988 Amendment 2:1995 Amendment to BS 5724-1:1989 General requirements for safety (To be published) IEC 601-1-1:1992 BS EN 60601-1-1:1993 Collateral standard Safety requirements for medical electrical systems IEC 601-1-2:1993 BS EN 60601-1-2:1993 Collateral standard Electromagnetic compatibility Requirements and tests IEC 788:1984 BS 6641:1985 Glossary of medical radiology terms Additional information The following print types are used in this standard Requirements, with which compliance can be tested, and definitions: in roman type Explanations, advice, general statements, exceptions and references: in small roman type Test procedures: in italic type Terms defined in clause of this standard or in BS 6641: SMALL CAPITALS For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored A British Standard does not purport to include all the necessary provisions of a contract Users of British Standards are responsible for their correct application Compliance with a British Standard does not of itself confer immunity from legal obligations Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages to 10, an inside back cover and a back cover This standard has been updated (see copyright date) and may have had amendments incorporated This will be indicated in the amendment table on the inside front cover ii © BSI 09-1999 EUROPEAN STANDARD EN 60601-2-9 NORME EUROPÉENNE December 1996 EUROPÄISCHE NORM Incorporates Corrigendum December 1996 ICS 11.040.50; 17.240 Descriptors: Medical electrical equipment, radiotherapy, dosemeters with electrically connected radiation detectors, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors (IEC 601-2-9:1996) Appareils électromédicaux Partie 2: Règles particulières de sécurité des dosimètres au contact du patient utilisés en radiothérapie avec des détecteurs de rayonnement reliés électriquement (CEI 601-2-9:1996) Medizinische elektrische Geräte Teil 2: Besondere Festlegungen für die Sicherheit von Dosimetern mit Patientenkontakt, die in der Strahlentherapie mit elektrisch verbundenen Strahlungsdetektoren verwendet werden (IEC 601-2-9:1996) This European Standard was approved by CENELEC on 1996-10-01 CENELEC 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 Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels ©1996 Copyright reserved to CENELEC members Ref No EN 60601-2-9:1996 E EN 60601-2-9:1996 Foreword Contents The text of document 62C/158/FDIS, future edition of IEC 601-2-9, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-9 on 1996-10-01 This European Standard supersedes HD 395.2.9 S1:1989 The following dates were fixed: Page Foreword Introduction Section General Scope and object Terminology and definitions Classification Identification, marking and documents Section Environmental conditions Section Protection against electric shock hazards 15 Limitation of voltage and/or energy Section Protection against mechanical hazards 21 Mechanical strength Section Protection against hazards from unwanted or excessive radiation Section Protection against hazards of ignition of flammable anaesthetic mixtures Section Protection against excessive temperatures and other safety hazards 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection Section Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data Section Abnormal operation and fault conditions; environmental tests Section 10 Constructional requirements Appendix L References — Publications mentioned in this Standard Annex AA (informative) Index of defined terms Annex ZA (normative) Normative references to international publications with their corresponding European publications 10 Annex ZB (informative) Normative references to international publications with their corresponding European publications 10 — latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 1997-07-01 — latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 1998-06-13 Annexes designated “normative” are part of the body of the standard Annexes designated “informative” are given for information only In this standard, Annex ZA is normative and Annex AA and Annex ZB are informative Annex ZA and Annex ZB have been added by CENELEC Endorsement notice The text of the International Standard IEC 601-2-9:1996 was approved by CENELEC as a European Standard without any modification © BSI 09-1999 EN 60601-2-9:1996 Introduction The use of DOSEMETERS in RADIOTHERAPY with electrically connected RADIATION DETECTORS may expose PATIENTS to danger if the RADIATION DETECTOR is in physical contact with a PATIENT and the DOSEMETER design does not satisfy standards of electrical and mechanical safety a) Most DOSEMETERS for RADIOTHERAPY are not intended for use in contact with a PATIENT: these should conform with the normal safety requirements for electronic measuring apparatus in IEC 1010-1 b) If the DETECTOR ASSEMBLY of a DOSEMETER is intended for use in contact with a PATIENT during RADIOTHERAPY, the more stringent requirements of this Particular Standard as regards electrical safety, robustness and disinfectability will be applied c) The MEASURING ASSEMBLY is designed to meet the requirements of IEC 601-1 for allowable PATIENT LEAKAGE CURRENTS because it is electrically connected to the RADIATION DETECTOR d) If DETECTOR ASSEMBLIES and MEASURING ASSEMBLIES are sold separately, or can be disconnected from each other, the USER needs to be told which particular DETECTOR ASSEMBLY/MEASURING ASSEMBLY combinations meet the requirements of this Particular Standard for use in contact with a PATIENT It is possible, for example, that a DETECTOR ASSEMBLY connected to an unsuitable MEASURING ASSEMBLY (even if they each met all requirements when connected to suitable partners) could unintentionally have its ACCESSIBLE CONDUCTIVE PARTS connected to the polarizing supply; such a combination would be unsafe because of the high probability of grounding of the polarizing supply through the PATIENT and, consequently, incorrect readings This Particular Standard establishes requirements to be complied with by MANUFACTURERS in the design and construction of RADIOTHERAPY DOSEMETERS intended for use in physical contact with a PATIENT © BSI 09-1999 Section General The clauses and subclauses of this section of the General Standard apply except as follows: Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies the particular requirements for the safety of DOSEMETERS used in medical practice in the PATIENT ENVIRONMENT for RADIOTHERAPY as defined in 2.104 NOTE DOSEMETERS not intended for use in the PATIENT ENVIRONMENT are not covered by this Standard and should the requirements of IEC 1010-1 meet The requirements of this Standard for electrical safety, robustness and disinfectability apply to DOSEMETERS with any type of electrically connected RADIATION DETECTOR intended for use in physical contact (not electrical contact) with a PATIENT The requirements for performance in IEC 731 apply only to DOSEMETERS with IONIZATION CHAMBERS as RADIATION DETECTORS The DOSE MONITORING SYSTEMS incorporated in RADIOTHERAPY EQUIPMENT are not covered by this Particular Standard 1.3 Particular Standards Addition: This Particular Standard is to be read in conjunction with IEC 601-1 (1988): Medical electrical equipment — Part 1: General requirement for safety, with amendments (1991) and (1995) For brevity Part is referred to in this Particular Standard either as the “General Standard” or as the “General Requirements” A requirement of this Particular Standard replacing or modifying a requirement of the General Standard takes precedence over the corresponding General Requirement(s) The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard The changes to the text of the General Standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard “Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard EN 60601-2-9:1996 “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc The term “this Standard” is used to make reference to the General Standard and this Particular Standard taken together Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard 2.103 1.5 Collateral Standards conducting parts of EQUIPMENT which can be touched without the use of a tool Replacement: This Standard is to be read in conjunction with the Collateral Standards IEC 601-1-1 and IEC 601-1-2 No other Collateral Standards apply Terminology and definitions RADIATION DETECTOR for this standard this is defined as the electrically operated element which directly transduces ABSORBED DOSE, ABSORBED DOSE RATE or any other dose related quantity, into a measurable electrical signal 2.104 (PATIENT CONTACT) DOSEMETER RADIATION METER used for the measurement on or in the PATIENT of ABSORBED DOSE, ABSORBED DOSE RATE, or any dose-related quantities in IONISING RADIATION, such as EXPOSURE or KERMA This EQUIPMENT usually consists of one or more RADIATION DETECTOR ASSEMBLIES (for example CHAMBER ASSEMBLIES) and a MEASURING ASSEMBLY 2.105 ACCESSIBLE CONDUCTIVE PARTS 2.106 DISINFECTABLE EQUIPMENT EQUIPMENT parts which come into contact with the PATIENT during normal use and which may be disinfected in accordance with the MANUFACTURER’S This clause of the General Standard applies except as follows: instructions 2.1.5 APPLIED STERILIZABLE EQUIPMENT PART Replacement: A part of a DOSEMETER, the RADIATION DETECTOR (for example CHAMBER ASSEMBLY) together with any additional protective cover provided by the MANUFACTURER, intended for physical contact (not electrical contact) with the PATIENT (for example for intracavitary use) Additional definitions: 2.101 MEASURING ASSEMBLY a device to convert the output from the RADIATION DETECTOR into a form suitable for DISPLAY, control or storage of the values of ABSORBED DOSE, ABSORBED DOSE RATE or any dose-related quantities It includes all electrical circuits in use during the period of patient contact up to and including any SEPARATION DEVICE(S) 2.107 EQUIPMENT parts which come into contact with PATIENT during normal use and which may be sterilized in accordance with MANUFACTURER’S the instructions Classification This clause of the General Standard applies except as follows: 5.3 Amendment: For the APPLIED PART only, delete all but WATERTIGHT EQUIPMENT Unless otherwise stated, the MEASURING ASSEMBLY is not specially protected against the ingress of liquids 5.6 Amendment: Delete all but CONTINUOUS OPERATION 2.102 DETECTOR ASSEMBLY the RADIATION DETECTOR and all other parts to which the RADIATION DETECTOR is permanently attached, except the MEASURING ASSEMBLY © BSI 09-1999 EN 60601-2-9:1996 Identification, marking and documents This clause of the General Standard applies except as follows: 6.1 Marking on the outside of EQUIPMENT and EQUIPMENT parts Additional items: aa) The only information required to be clearly marked on the DETECTOR ASSEMBLY or on a permanently affixed label is: — the indication of origin; — the model or type number; — the serial number; particular models of suitable MEASURING ASSEMBLIES may be referred to in the warning bb) The following additional information shall be clearly marked on the MEASURING ASSEMBLY: — an indication of the types or models of DETECTOR ASSEMBLY with which the MEASURING ASSEMBLY makes a complete EQUIPMENT which meets the requirements of this standard 6.8 ACCOMPANYING DOCUMENTS 6.8.2 Instructions for use Additional item: aa) The instructions for use shall in addition contain: — a warning that misuse of the DOSEMETER can cause a hazard if a MEASURING ASSEMBLY and an APPLIED PART are used as a complete EQUIPMENT, unless stated to be suitable for that purpose; — information on which APPLIED PARTS are suitable for use with a particular MEASURING ASSEMBLY for which the classification of 5.2 is claimed; — the value of LEAKAGE CURRENT (or drift) for the DETECTOR ASSEMBLY; — an indication that the APPLIED PART is WATERTIGHT EQUIPMENT and, if the DETECTOR ASSEMBLY is a CHAMBER ASSEMBLY, whether the SENSITIVE VOLUME is vented to the atmosphere; — if it has ACCESSIBLE CONDUCTIVE PARTS, a warning that the DOSEMETER must not be used in contact with a PATIENT unless it is connected to a MEASURING ASSEMBLY which is designed so that the complete EQUIPMENT meets the requirements of TYPE B, BF or CF EQUIPMENT Section Environmental conditions The clauses and subclauses of this section of the General Standard apply Section Protection against electric shock hazards The clauses and subclauses of this section of the General Standard apply except as follows: 15 Limitation of voltage and/or energy This clause of the General Standard applies except as follows: Additional item: aa) The output from the energizing supply terminal to which the APPLIED PART is normally connected (for example the polarizing voltage supply to an IONIZATION CHAMBER) shall not exceed the allowable value of PATIENT LEAKAGE CURRENT (SINGLE FAULT CONDITION) in Table IV In addition, the current available shall not exceed 0,5 mA Compliance is checked by measurement Section Protection against mechanical hazards The clauses and subclauses of this section of the General Standard apply except as follows: 21 Mechanical strength This clause of the General Standard applies except as follows: 21.5 Addition: Requirements for hand-held parts shall apply to the APPLIED PART In addition: 1) After the test specified, the RESPONSE of the APPLIED PART shall not change by more than ± % Compliance is checked by measuring the RESPONSE of the APPLIED PART before and after the test 2) After the test specified the LEAKAGE CURRENT (drift) shall remain within the value specified by the MANUFACTURER Compliance is checked by measuring the LEAKAGE CURRENT (or drift) before and after the test Section Protection against hazards from unwanted or excessive radiation The clauses and subclauses of this section of the General Standard apply © BSI 09-1999 EN 60601-2-9:1996 Section Protection against hazards of ignition of flammable anaesthetic mixtures Section Accuracy of operating data and protection against hazardous output The clauses and subclauses of this section of the General Standard apply The clauses and subclauses of this section of the General Standard apply except as follows: Section Protection against excessive temperatures and other safety hazards 50 Accuracy of operating data The clauses and subclauses of this section of the General Standard apply except as follows: 50.1 Marking of controls and instruments 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection This clause of the General Standard applies except as follows: 44.7 Cleaning, sterilization and disinfection Addition: The APPLIED PART shall be DISINFECTABLE EQUIPMENT or STERILIZABLE EQUIPMENT Replacement of the last two sentences of the test specification: After the relevant procedure for disinfection or sterilization specified in the General Standard: 1) the RESPONSE of the APPLIED PART shall not change by more than ± % Compliance is checked by measuring the RESPONSE of the APPLIED PART before and after the test 2) the LEAKAGE CURRENT (or drift) shall remain within the value specified by the MANUFACTURER Compliance is checked by measuring the LEAKAGE CURRENT (or drift) before and after the test This clause of the General Standard applies except as follows: Addition: with CHAMBER ASSEMBLIES intended for use in contact with PATIENTS shall comply with the performance requirements for FIELD-CLASS INSTRUMENTS in clauses 3, 4, and of IEC 731 for high-energy radiations The MANUFACTURER shall state in the ACCOMPANYING DOCUMENTS any departures from these performance requirements DOSEMETERS Section Abnormal operation and fault conditions; environmental tests The clauses and subclauses of this section of the General Standard apply Section 10 Constructional requirements The clauses and subclauses of this section of the General Standard apply © BSI 09-1999 EN 60601-2-9:1996 The appendices of the General Standard apply except as follows: Appendix L References — Publications mentioned in this Standard Appendix L of the General Standard applies except as follows: Addition: IEC 601-1:1988, Medical electrical equipment — Part 1: General requirements for safety Amendment (1991) Amendment (1995) IEC 601-1-1:1992, Medical electrical equipment — Part 1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems Amendment (1995) IEC 601-1-2:1993, Medical electrical equipment — Part 1: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests IEC 731:1982, Medical electrical equipment — Dosimeters with ionization chambers as used in radiotherapy Amendment (1987) IEC 788:1984, Medical radiology — Terminology IEC 1010-1:1990, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1: General requirements Amendment (1992) Amendment (1995) © BSI 09-1999 EN 60601-2-9:1996 Annex AA (informative) Index of defined terms ABSORBED DOSE ABSORBED DOSE RATE ACCESSIBLE CONDUCTIVE PARTS ACCESSORY ACCOMPANYING DOCUMENTS APPLIED PART (731) A2.1.1 (601-1) 2.10.2 CHAMBER ASSEMBLY CONTINUOUS OPERATION DETECTOR ASSEMBLY DISINFECTABLE EQUIPMENT DISPLAY DOSE MONITORING SYSTEM DOSEMETER 2.102 2.106 (788) rm-84-01 (788) rm-33-01 (788) rm-50-02 (601-1) 2.2.15 (788) rm-13-14 EQUIPMENT EXPOSURE FIELD-CLASS INSTRUMENT Source reference (788) rm-13-08 (788) rm-13-09 2.105 (601-1) 2.1.3 (601-1) 2.1.4 (601-1) 2.1.5 (dosemeter) (731) A2.2.8 IONIZING RADIATION (788) rm-51-03 (788) rm-11-02 KERMA (788) rm-13-10 LEAKAGE CURRENT (601-1) 2.5.3 MANUFACTURER (788) rm-85-032.101 (601-1) 2.2.15 IONIZATION CHAMBER MEASURING ASSEMBLY MEDICAL ELECTRICAL EQUIPMENT PATIENT PATIENT CONTACT DOSEMETER PATIENT ENVIRONMENT PATIENT LEAKAGE CURRENT (601-1) 2.12.4 2.104 (601-1-1) 2.204 (601-1) 2.5.6 © BSI 09-1999 EN 60601-2-9:1996 RADIATION DETECTOR RADIATION DETECTOR ASSEMBLY RADIATION METER RADIOTHERAPY RADIOTHERAPY DOSEMETER RESPONSE SENSITIVE VOLUME SEPARATION DEVICE SINGLE FAULT CONDITION STERILIZABLE EQUIPMENT 2.103 (788) rm-34-11 (788) rm-50-01 (788) rm-40-05 (731) 3.1 (731) A2.5.13 (788) rm-51-07 (601-1-1) 2.205 (601-1) 2.12.11 2.107 TYPE CF EQUIPMENT (601-1) 2.1.24 (601-1) 2.1.25 (601-1) 2.1.26 USER (601-1) 2.12.13 WATERTIGHT EQUIPMENT (601-1) 2.2.28 TYPE B EQUIPMENT TYPE BF EQUIPMENT © BSI 09-1999 EN 60601-2-9:1996 Annex ZA (normative) Normative references to international publications with their corresponding European publications This European Standard incorporates by dated or undated reference, provisions from other publications These normative references are cited at the appropriate places in the text and the publications are listed hereafter For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision For undated references the latest edition of the publication referred to applies (including amendments) NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies Publication Year Title EN/HD Year Addition to (replacement in) Annex ZA of EN 60601-1:1990/A2:1995 IEC 601-1 1988 Medical electrical equipment EN 60601-1 Part 1: General requirements for + corr July safety A1 1991 A1 + corr July A2 1995 A2 A13 IEC 601-1-1 1992 Collateral standard: Safety EN 60601-1-1 requirements for medical electrical systems A1 1995 A1 IEC 601-1-2 1993 Collateral standard: EN 60601-1-2 Electromagnetic compatibility — Requirements and tests IEC 731 1982 Medical electrical equipment — Dosimeters with ionization chambers as used in radiotherapy + A1 1987 HD 534 S1 IEC 788 1984 Medical radiology — Terminology HD 501 S1 1990 1994 1993 1994 1995 1996 1993 1996 1993 1989 1988 Annex ZB (informative) Normative references to international publications with their corresponding European publications Publication Year Title EN/HD Year EN 61010-1 A2 1993 1995 Addition to Annex ZB of EN 60601-1:1990/A2:1995 IEC 1010-1 (mod) 1990 + A1 (mod) A2 1992 1995 10 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements © BSI 09-1999 BS EN 60601-2-9:1997 List of references See national foreword © BSI 09-1999 BS EN 60601-2-9:1997 BS 5724-2.9: 1997 IEC 601-2-9: 1996 BSI — British Standards Institution BSI is the independent national body responsible for preparing British Standards It presents the UK view on standards in Europe and at the international level It is incorporated by Royal Charter Revisions British Standards are updated by amendment or revision Users of British Standards should make sure that they possess the latest amendments or editions It is the constant aim of BSI to improve the quality of our products and services We would be grateful if anyone finding an inaccuracy or ambiguity while using this British 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