SIST EN 62083:2002
(Main)Medical electrical equipment -- Requirements for the safety of radiotherapy treatment planning systems
Medical electrical equipment -- Requirements for the safety of radiotherapy treatment planning systems
Applies to the design, manufacture and some installation aspects of an RTPS - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or direct from other devices; - that outputs data either in printed form for review or direct to other devices; - and which is intended to be . for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; . maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and . used within the environmental and electrical supply conditions SPECIFIED in the technical descriptions. An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software.
Medizinische elektrische Geräte -- Festlegungen für die Sicherheit von Bestrahlungsplanungssystemen
Appareils électromédicaux -- Règles particulières de sécurité pour les systèmes de planification de traitement en radiothérapie
S'applique à la conception, à la fabrication ainsi qu'à certains aspects de l'installation des SPTR - qui sont utilisés en médecine humaine pour la PLANIFICATION DES TRAITEMENTS de RADIOTHERAPIE; - qui utilisent des données entrées par l'OPERATEUR ou importées directement depuis d'autres dispositifs; - qui produisent des données de sortie qui sont soit imprimées pour être revues, soit exportées directement vers d'autres dispositifs; - et qui sont destinés à . être utilisés en UTILISATION NORMALE, sous la responsabilité de PERSONNES QUALIFIEES ou agréées à cet effet, par des OPERATEURS ayant les compétences et la formation nécessaires; . être entretenus conformément aux recommandations données dans les INSTRUCTIONS D'UTILISATION, et . être utilisés selon les conditions d'environnement et d'alimentation électrique SPECIFIEES dans la description technique. Un SPTR est principalement une application logicielle, et la présente norme a pour objet d'établir des prescriptions pour les caractéristiques, pour la documentation associée et pour les essais du logiciel.
Medical electrical equipment - Requirements for the safety of radiotheraphy treatment planning systems (IEC 62083:2000)
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Standards Content (Sample)
SLOVENSKI SIST EN 62083:2002
prva izdaja
STANDARD
junij 2002
Medical electrical equipment - Requirements for the safety of radiotheraphy
treatment planning systems (IEC 62083:2000)
ICS 11.040.60 Referenčna številka
SIST EN 62083:2002(en)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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EUROPEAN STANDARD EN 62083
NORME EUROPÉENNE
EUROPÄISCHE NORM February 2001
ICS 11.040.60
English version
Medical electrical equipment
Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2000)
Appareils électromédicaux Medizinische elektrische Geräte
Règles particulières de sécurité Festlegungen für die Sicherheit von
pour les systèmes de planification de Bestrahlungsplanungssystemen
traitement en radiothérapie (IEC 62083:2000)
(CEI 62083:2000)
This European Standard was approved by CENELEC on 2000-12-01. 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, Czech Republic,
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
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62083:2001 E
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EN 62083:2001 - 2 -
Foreword
The text of document 62C/280/FDIS, future edition 1 of IEC 62083, 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 62083 on 2000-12-01
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2001-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2003-12-01
NOTE In this standard, the following print types are used:
- requirement: in roman type;
- test specifications: in italic type;
- notes: in smaller roman type.
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes A, C and ZA are normative and annex B is informative.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62083:2000 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-2-1 NOTE: Harmonized as en 60601-2-1:1998 (not modified).
__________
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- 3 - EN 62083:2001
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
1) 2)
IEC 60601-1 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety
1) 2)
IEC 60601-1-2 Medical electrical equipment EN 60601-1-2 1993
2)
Part 1: General requirements for safety -- + corr. December 1997
2. Collateral standard: Electromagnetic
compatibility - Requirements and tests
1) 2)
IEC 60601-1-4 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety
-- Collateral standard: Programmable
electrical medical systems
1) 2)
IEC 60788 Medical radiology - Terminology HD 501 S1 1988
1) 2)
IEC 60950 (mod) Safety of information technology EN 60950 2000
equipment
1) 2)
IEC 61000-4-1 Electromagnetic compatibility (EMC) EN 61000-4-1 2000
Part 4-1: Testing and measurement
techniques - Overview of IEC 61000-4
series
1) 2)
IEC 61000-4-2 Part 4-2: Testing and measurement EN 61000-4-2 1995
techniques - Electrostatic discharge
immunity test
1) 2)
IEC 61000-4-3 Part 4-3: Testing and measurement
EN 61000-4-3 1996
(mod) techniques - Radiated, radio-frequency,
electromagnetic field immunity test
1) 2)
IEC 61000-4-4 Part 4-4: Testing and measurement EN 61000-4-4 1995
techniques - Electrical fast transient/burst
immunity test
1)
undated reference.
2)
valid edition at date of issue.
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EN 62083:2001 - 4 -
Publication Year Title EN/HD Year
1) 2)
IEC 61217 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
ICRU rapport 42 1987 Use of Computers in External Beam --
Radiotherapy Procedures with high
Energy Photons and Electrons
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NORME CEI
INTERNATIONALE IEC
62083
INTERNATIONAL
Première édition
STANDARD
First edition
2000-11
Appareils électromédicaux –
Règles particulières de sécurité
pour les systèmes de planification
de traitement en radiothérapie
Medical electrical equipment –
Requirements for the safety of
radiotherapy treatment planning systems
IEC 2000 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun procédé, any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission in
microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
U
PRICE CODE
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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62083 © IEC:2000 – 3 –
CONTENTS
Page
FOREWORD . 7
INTRODUCTION . 11
Clause
1 Scope and object . 13
2 Normative references . 13
3 Relationship to other standards . 15
3.1 Hardware SAFETY standards . 15
3.2 Software SAFETY standards . 15
3.3 IEC 61217 Radiotherapy equipment – Coordinates, movements and scales . 15
4 Terminology and definitions. 15
5 General requirements for tests . 17
5.1 Testing during development . 17
5.2 Testing during installation. 17
6ACCOMPANYING DOCUMENTS. 19
7 General requirements for operational safety . 21
7.1 Distances and linear dimensions . 21
7.2 RADIATION quantities . 21
7.3 Date and time format. 21
7.4 Protection against unauthorized use . 21
7.5 Data limits. 23
7.6 Protection against unauthorized modification . 25
7.7 Correctness of data transfer. 25
7.8 Coordinate systems and scales . 25
7.9 Saving and archiving data . 25
8 RADIOTHERAPY TREATMENT EQUIPMENT and BRACHYTHERAPY SOURCE MODELLING. 27
8.1 General. 27
8.2 Dosimetric information . 29
8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance. 29
8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion . 31
9ANATOMY MODELLING . 31
9.1 Data acquisition . 31
9.2 Coordinate systems and scales . 31
9.3 Contouring of regions of interest. 33
9.4 PATIENT ANATOMY MODEL acceptance . 33
9.5 PATIENT ANATOMY MODEL deletion. 35
10 TREATMENT PLANNING. 35
10.1 General requirements. 35
REATMENT PLAN
10.2 T preparation . 35
10.3 TREATMENT PLAN identification . 37
10.4 TREATMENT PLAN deletion. 37
10.5 Electronic signatures. 37
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62083 © IEC:2000 – 5 –
Clause Page
11 ABSORBED DOSE distribution calculation. 37
11.1 Algorithms used . 37
11.2 Accuracy of algorithms . 39
12 TREATMENT PLAN report. 41
12.1 Incomplete TREATMENT PLAN report . 41
12.2 Information on the TREATMENT PLAN report . 41
12.3 Transmitted TREATMENT PLAN information. 43
13 General hardware diagnostics . 43
14 Arithmetic processor . 43
15 Data and code. 43
16 Human errors in software design . 45
17 Change in software versions. 45
18 Human errors in use. 47
Annex A (normative) Hardware safety . 49
A.1 General requirements. 49
A.2 Completeness of hardware SAFETY . 51
A.3 Completeness of ACCOMPANYING DOCUMENTS . 51
Annex B (informative) Imported and exported data. 53
Annex C (normative) Terminology – Index of defined terms. 55
Bibliography . 59
Table 1 – Clauses and subclauses in this standard that require the provision of information
in the ACCOMPANYING DOCUMENTS and the technical description . 19
Table A.1 – Table indicating correlation . 49
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62083 © IEC:2000 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Requirements for the safety of
radiotherapy treatment planning systems
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62083 has been prepared by subcommittee 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/280/FDIS 62C/288/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes A and C form an integral part of this standard.
Annex B is for information only.
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62083 © IEC:2000 – 9 –
In this standard, the following print types are used:
– Requirements, compliance with which can be tested, and definitions: in roman type.
– Notes, explanations, advice, general statements, and exceptions: in small roman type.
– Test specifications: in italic type.
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN ANNEX C AND DEFINED IN
CLAUSE 4, OR IN IEC 60601-1 AND ITS COLLATERAL STANDARDS, OR IN IEC 60788: SMALL
CAPITALS.
Certain defined terms have been abbreviated, namely:
Defined term Abbreviation
RADIOTHERAPY TREATMENT PLANNING SYSTEM RTPS
BEAM LIMITING DEVICE BLD
COMPUTED TOMOGRAPHY CT
MAGNETIC RESONANCE IMAGING MRI
CENTRAL PROCESSING UNIT CPU
The committee has decided that the contents of this publication will remain unchanged
until 2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
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62083 © IEC:2000 – 11 –
INTRODUCTION
A RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS) is a device, usually a PROGRAMMABLE
ELECTRONIC SYSTEM, that is used to simulate the application of RADIATION to a PATIENT for a
proposed RADIOTHERAPY treatment. It usually, but not necessarily, provides estimates of
ABSORBED DOSE distribution in human tissue using a particular algorithm or algorithms. These
estimations, referred to in this International Standard as ABSORBED DOSE distributions, are used
by a QUALIFIED PERSON in planning a course of RADIOTHERAPY.
The output of an RTPS is used by appropriately QUALIFIED PERSONS as important information in
RADIOTHERAPY TREATMENT PLANNING. Inaccuracies in the input data, the limitations of the
algorithms, errors in the TREATMENT PLANNING process, or improper use of output data, may
represent a SAFETY HAZARD to PATIENTS should the resulting data be used for treatment
purposes. This standard defines requirements to be complied with by MANUFACTURERS in the
design and construction of an RTPS in order to provide protection against the occurrence of
such HAZARDS.
Specific types of input data and calculation algorithms are not addressed in this standard.
These are dependent on many factors, such as available technology, USER preference, and the
type of treatment being planned. However, this standard establishes the SAFETY requirements
that are common to algorithms. It also establishes the minimum requirements for the contents
of the ACCOMPANYING DOCUMENTS that will permit the USER to make informed choices during the
TREATMENT PLANNING process.
NOTE As it is not used in the presence of PATIENTS, an RTPS is not MEDICAL ELECTRICAL EQUIPMENT as defined
by IEC 60601-1. Consequently, this standard is written in an independent format rather than as a particular
standard to IEC 60601-1. Clause 3 contains related information.
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62083 © IEC:2000 – 13 –
MEDICAL ELECTRICAL EQUIPMENT –
Requirements for the safety of
radiotherapy treatment planning systems
1 Scope and object
This International Standard applies to the design, manufacture and some installation aspects of
an RTPS
– for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;
– that imports data either through input by the OPERATOR or direct from other devices;
– that outputs data either in printed form for review or direct to other devices;
– and which is intended to be
• for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by
OPERATORS having the required skills and training;
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR
USE, and
• used within the environmental and electrical supply conditions SPECIFIED in the technical
description.
An RTPS developed by a USER for its own use exclusively is not within the scope of this
standard, but it is highly recommended that the principles of this standard be applied in its
creation and use. If such an RTPS is provided to another USER in which the developers do not
directly control its use, and is represented as being suitable for use, then the developers
MANUFACTURER
assume the role of , and this standard applies.
An RTPS is principally a software application, and the object of this standard is to establish
the requirements for features, associated documentation, and testing of the software.
Requirements for SAFETY of hardware are not included in this standard, as they vary with the
nature of the hardware. See 3.1 and annex A for hardware requirements.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this International Standard. For dated references, subsequent
amendments to, or revisions of, any of these publications do not apply. However, parties to
agreements based on this International Standard are encouraged to investigate the possibility
of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of IEC
and ISO maintain registers of currently valid International Standards.
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1-2, Medical electrical equipment – Part 1: General requirements for safety – 2.
Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4, Medical electrical equipment – Part 1: General requirements for safety – 4.
Collateral Standard: Programmable electrical medical systems
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62083 © IEC:2000 – 15 –
IEC 60788, Medical radiology – Terminology
IEC 60950, Safety of information technology equipment
IEC 61000-4-1, Electromagnetic compatibility (EMC) – Part 4-1: Testing and measurement
techniques – Overview of IEC 61000-4 series
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4: Testing and measurement
techniques – Section 4: Electrical fast transient/burst immunity test. Basic EMC Publication
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
ICRU report 42:1987: Use of Computers in External Beam Radiotherapy Procedures with high
Energy Photons and Electrons
3 Relationship to other standards
3.1 Hardware SAFETY standards
Requirements for the SAFETY of hardware, such as for protection against electric shock and
fire, and to assure for ELECTROMAGNETIC COMPATIBILITY, are not included in this standard.
SAFETY requires that these subjects be addressed by the MANUFACTURER separately through
compliance with an appropriate standard, depending upon the nature and environment of the
hardware used for the RTPS. See annex A for hardware SAFETY standards.
3.2 Software SAFETY standards
An RTPS is principally a software application for a medical purpose.
IEC Collateral Standard 60601-1-4 applies (see clause 16).
3.3 IEC 61217 Radiotherapy equipment – Coordinates, movements and scales
IEC 61217 gives guidance on the designation of EQUIPMENT movements, the marking of scales,
their zero position and the direction of movement with increasing value. The means of applying
IEC 61217 are specified in appropriate clauses and subclauses of this standard.
4 Terminology and definitions
For the purpose of this International Standard, the following terms and definitions apply, in
addition to the index of defined terms listed in annex C.
4.1
EQUIPMENT MODEL/EQUIPMENT MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY
for particular EQUIPMENT. The process of establishing the EQUIPMENT MODEL is referred to as
"EQUIPMENT MODELLING"
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62083 © IEC:2000 – 17 –
4.2
BRACHYTHERAPY SOURCE MODEL/BRACHYTHERAPY SOURCE MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY
for a particular BRACHYTHERAPY RADIOACTIVE SOURCE. The process of establishing the
BRACHYTHERAPY SOURCE MODEL is referred to as "BRACHYTHERAPY SOURCE MODELLING"
4.3
PATIENT ANATOMY MODEL/ANATOMY MODELLING
all physical and anatomical parameters required to plan a course of RADIOTHERAPY for a
particular PATIENT. The process of establishing the PATIENT ANATOMY MODEL is referred to as
"ANATOMY MODELLING"
4.4
TREATMENT PLAN/TREATMENT PLANNING
PATIENT QUALIFIED
all and dosimetric information that is intended for use by appropriately
PERSONs for the purpose of prescribing or administering RADIOTHERAPY treatment. A TREATMENT
PLAN includes information transmitted to other EQUIPMENT for which the use of the information
for prescribing or administering IRRADIATION is indirect. A printed or plotted TREATMENT PLAN is
referred to as a TREATMENT PLAN report
4.5
RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS)
a device, usually a PROGRAMMABLE ELECTRONIC SYSTEM including its associated peripherals,
that is used to simulate the application of RADIATION to a PATIENT for a proposed RADIOTHERAPY
treatment. It usually, but not necessarily, provides estimations of ABSORBED DOSE distribution in
human tissue using a particular algorithm or algorithms. These algorithms provide simulations
of RADIATION that is typically from, but not necessarily limited to, MEDICAL ELECTRON ACCELE-
RATORS, GAMMA BEAM THERAPY EQUIPMENT, or RADIOACTIVE SOURCES when BRACHYTHERAPY is
planned.
5 General requirements for tests
5.1 Testing during development
Compliance with IEC 60601-1-4 requires identification of HAZARDS, assessment of their RISKS,
and appropriate verification and validation of RISK controls. Demonstration of compliance with
the requirements of this standard shall be included as part of the above processes, with explicit
reference to each requirement. Compliance data shall be retained by the MANUFACTURER as a
permanent record. Each test shall include a protocol containing all the necessary input data,
sufficient detail to provide for exact reproducibility, and the expected result. A summary
description of the tests performed to demonstrate compliance to each clause and subclause of
this standard shall be included in the technical description.
5.2 Testing during installation
The MANUFACTURER shall provide an installation test document as part of the technical
description that includes, as a minimum, performance of the ABSORBED DOSE distribution
calculation algorithm tests given in 11.2. The tests shall also demonstrate correct functioning of
the RTPS hardware components and their ability to achieve predetermined results when
performing TREATMENT PLANNING functions.
TREATMENT PLANNING MANUFACTURER
NOTE Due to the complexity of functions, it is usually not possible for the to
demonstrate complete fitness for use of the RTPS at time of installation. Operational problems detected after
installation will normally be addressed subject to the conditions of the contract (see also item b) of clause 16).
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62083 © IEC:2000 – 19 –
6 ACCOMPANYING DOCUMENTS
The technical description and the INSTRUCTIONS FOR USE shall contain the information as
required by this standard (see table 1 for references).
Table 1 – Clauses and subclauses in this standard that require
the provision of information in the ACCOMPANYING
DOCUMENTS and the technical description
Check INSTRUCTIONS Technical
reference FOR USE description
15.1
25.2
3 7.4 a)
4 7.4 b)
57.5
6 7.7 a)
7 7.7 b)
87.8
9 8.1 g)
10 8.2 b)
11 9.1 a)
12 9.2 a)
13 9.2 c)
14 9.3 c)
15 10.2 a)
16 10.5 a)
17 11.1 a)
18 11.1
...
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