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2011 First International Workshop on Software Certification

Investigation on Safety-related Standards for


Critical Systems
Christian Esposito and Domenico Cotroneo Nuno Silva
Consorzio Interuniversitario Nazionale Critical Software,
per l’Informatica (CINI), via Cinthia, Parque Industrial de Taveiro, Lt 48,
Campus Monte S. Angelo, Napoli, Italy Coimbra, Portugal
{christian.esposito, cotroneo}@unina.it nsilva@criticalsoftware.com

Abstract—In each application domain for safety-critical sys- product actually meets the user’s needs [1].
tems, international organizations have issued regulations con- During the last decades, several specifications have been
cerned with the development, implementation, validation and
proposed by international organizations to standardize the
maintenance of safety-critical systems. In particular, each of them
indicate a definition of what safety means, proper qualitative series of activities that compose a V&V process. Some exhibit
and quantitative properties for evaluating the quality of the a generic multi-domain nature, such as IEC 61508, but other
system under development, and a set of methodologies to be ones are tailored to specific application domains, e.g., aeronau-
used for assessing the fulfilment of the mentioned properties. tic or space. The scope of this paper is to highlight the key
These standards are today and essential tool for ensuring the
characteristics and the V&V process proposed by some key
required safety levels in many domains that require extremely
high dependability. This paper summarizes the analysis on a standards, and to identify the methods recommended by such
set of well-known safety standards in different domains of different standards to perform V&V activities. Specifically, we
critical systems with the intend of highlighting similarities and have considered and studied the standards listed in Table I,
differences among them, pointing out common areas of interest and analyzed their similarities and differences so to point out
and reporting on which features the newest (and upcoming)
common areas of interest, and features in which they diverge.
standards are focusing.
Last, we also present a preview of future evolution for some of
I. I NTRODUCTION the mentioned standards (i.e., DO-178C, or the new ISO/IEC
29119 Software Testing standard).
Systems can be defined as safety-critical if the consequences
of a failure could lead to loss of life, significant property II. S TATE OF THE ART AND R ELATED WORK
damage, or damage to the environment. Due to such severe
consequences of a failure occurring in these systems, it is In the current research literature, it is possible to find other
mandatory to adopt a proper development process with activ- research papers that focus on certain safety-related standards
ities that aim at achieving and preserving the safety require- and propose some kinds of comparisons among them. We have
ments imposed upon these systems. Such activities are known studied a large amount of these papers, and classified them
in literature as Verification and Validation (V&V) process. based on their scope:
With few words, we can define Verification as the process to 1) Papers aiming at overviewing the activities and methods
check if we are building the system right. More specifically, recommended by one, or even more, standard. A con-
the system under development is tested so to ensure that it fully crete example is represented by [2], which presents the
meets its functional requirements, described as a set of inputs main aspects of the IEC 61508 standard.
to which corresponds a certain behavior and outputs. Such tests 2) Papers illustrating practical experiences in applying
are typically conducted, for example, by looking at the output safety-related standards, such as [3] that talks about 25
responses to various combinations of inputs, and the goal is to assessments conducted using IEC 61508 or IEC 61511.
look for eventual bugs within the system code, so that proper 3) Papers presenting the evolution from one version to an
debugging methods allows the programmer to correct them. other one of a given standard, such as [4] that discusses
On the other hand, Validation is briefly definable as a series some features of the 2000 version of IEC 61508 standard
of activities to test if we are building the right system. More and indicates the main changes incorporated into its new
specifically, it aims at ensuring that the system performs as it is edition, published in 2010.
supposed to do (without unintended functions), and measuring 4) Papers proposing methods and tools to be used within
its quality, i.e., it meets key features, such as performance, the context of safety-related standards to improve their
safety or security. In other words, verification is guaranteeing application and achievable results. Examples are [5],
that the system has been devised according to the requirements which introduces a conceptual model for evidences used
and design specifications, while validation ensures that the to reason about software safety, and [6], which proposes

978-0-7695-4617-9/11 $26.00 © 2011 IEEE 49


DOI 10.1109/WoSoCER.2011.9
TABLE I
a workflow for verification and validation of models and M AIN STANDARDS IN THE DIFFERENT APPLICATION DOMAINS .
generated code.
Application
5) Papers analyzing and then, criticizing some of the main Standard
Domain
Scope
features of one, or even more, standard. A practical IEEE 1012-
Generic
A complete Methodology for V&V process for soft-
examples is [7], which provides suggestions for im- 2004 ware being developed, maintained, or reused.
Functional Safety for Electrical/ Elec-
provements to the IEC 61508 standard. IEC 61508 Generic tronic/Programmable Electronic (E/E/PS) Safety-
6) Papers comparing safety-related standards belonging related Systems, and methods to guarantee it.
Automotive
only to one particular application domain, such as [8] ISO 26262 Adaptation of IEC 61508 for the automotive industry.
Domain
that discusses the application of IEC 61508 and IEC EN 501262
(A) Process for managing dependability, and for
demonstrating that requirements have been met. (B)
60880 in the domain of nuclear plants. and EN Railways
Procedures and technical requirements for the devel-
501281
7) Papers comparing safety-related standards of more than opment of software.
Nuclear Software aspects for I&C systems performing cate-
one domain. Such papers may be focused on the overall IEC 60880
Plants gory A functions.
regulation, such as [9] that explores the differences and DO-178B
Aeronautics Aspects of airworthiness certification that pertain to
Domain the production of software for airborne systems.
similarities between DO-178B (aeronautics domain) and Euro-
Aeronautics Best practices for safety assessment of Air Naviga-
MIL-STD-498 (defence domain), and [10] that provides CONTROL
Domain tion Systems and guidance for their application.
a comparison of ISO 26262 (autonomic domain) and - SAM
Defence (A) Safety programme requirements. (B) Require-
DO-178B (aeronautics domain), or even focused on a Standard Defence ments for the development of safety related software,
particular aspect of the standards, such as [11] that 00-562 and Domain covering specification, design, coding, test and inte-
00-551 gration.
investigates the application of formal methods in several MIL-STD-
(A) Requirements for implementing a safety pro-
different standards. 882D2 and Defence
gram, so to identify hazards and prevent mishaps.
MIL-STD- Domain
(B) Activities required for software development.
Clearly, our work is out of the scope of the first four mentioned 4981
classes, so we moved our attention to the remaining ones. Fo- ECSS series Space Do- Management, engineering and product assurance in
of standards main space projects and applications.
cusing on standards belonging to the same application domain NASA- Software safety activities, data, and documentation
Space Do-
would not provide us a clear picture of the current practice and STD- necessary for the acquisition or development of soft-
main
8719.13B ware in a safety-critical system.
methods for V&V process in safety-critical systems; therefore, Cost effective and reproducible Independent Soft-
we had to enlarge our analysis bringing in representative ESA ISVV Space Do- ware Verification and Validation (ISVV) process,
Guide main and best practices for the different verification and
standards for the main domains of such systems. Therefore, validation activities.
the only papers that are related to our work belong to the last 1
Requirements for development process.
class of the previous classification. In particular, our work goes 2
Requirements for safety management.
beyond [9], [10] and [11], since in the first two cases we have
analyzed a larger set of standards, and in the last case we have
focused our attention to a broader group of methods in our
development process of safety-critical systems, such as EN
comparison. The only work that is closer to ours is the brief
50128, while one, i.e., the series of standards from European
overview of safety-related standards provided by [12], since
Cooperation on Space Standardization (ECSS), covers the
it analyze a large number of standards with respect to several
full spectrum of System Development Process (SDP) and is
different aspects, as we do. However, despite having some
composed of 21 different standards, each on a particular aspect
comparison metrics in common, we introduce other ones, such
and/or method applicable within SDP.
as use of fault-injection or description of the risk and hazard
The following subsections summarize the comparison with
assessment, that [12] does not consider in its overview.
respect to a given metric among the following ones, which can
III. S TANDARDS C OMPARISON be found more detailed in Tables I-IV of [13]:
For our comparison, we have analyzed the standards listed 1) Terminology - comparison on the meaning assigned
in Table I, which have been extensively adopted in the industry, within the context of the standards to common terms
precisely ten taken from six different application domains such as safety, error, failure and fault, and comparison
and two exhibiting a generic nature and applicable to any with the commonly-accepted definition within the aca-
possible safety-critical system. Generally speaking, safety- demic community;
related standards have two aspects: 1) requirements for the 2) Safety Life Cycle and Safety Management - activities
process for developing highly reliable software, encompassing in charge of proving the achievement of safety, and
specification, design and verification; and 2) requirements for indication of a planning of such activities within the
safety management, including the way that the possibility of context of the system development process;
software failure is allowed for in the system safety analysis. 3) Software Development Life Cycle - activities for soft-
These aspects can be covered in a single standard, as in eight ware design and implementation;
of the selected standards, but in other cases, two or more 4) Software and Hardware Relation - point of view of the
standards are needed to cover the required scope. Specifically, selected standards with respect to hardware components;
three of them comprise a couple of documents, one on the 5) Reliability, Availability, Maintainability and Safety
V&V process, such as EN 50126, and one on the generic (RAMS) Analysis - inclusion of a methodology for

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performing proper RAMS analysis; c) Software Development Life Cycle: As mentioned be-
6) Safety Integrity Levels - measure of the degree of criti- fore, we have two extreme perspective: standards, such as
cality for each component within the system, obtained by IEC 61508, that do not indicate any particular software de-
considering the consequences of failures, and indication velopment life cycle, and standards, such as ISO 26262, even
of the method used for assigning such levels; if derived from IEC 61508, indicate a specific development
7) Risk and Hazard Analysis - recommendations on which model (e.g., ISO 26262 is based upon a V-Model as a reference
method adopt for these activities; soft- ware development process). In the middle we have
8) Verification and Validation - definition of this activity MIL-STD-498 that presents the main activities for software
and its implementation; development, but with no fixed order nor delivery timing of
9) Fault Injection, Testing, Formal Methods, Failure Mode documentation.
and Effect Analysis (FMEA)/Failure Mode, Effects, and d) Software and Hardware Relation: IEC 61508 and ISO
Criticality Analysis (FMECA) and Fault Tree Analysis 26262 do not only focus on software components, but also on
(FTA) - role of these methods within the context of the hardware ones. On the contrary, the other ones only focus
V&V process envisioned by the selected standards. on developing software items, but they do consider hardware-
a) Terminology: In general, we have noticed that there level entities for (i) identifying hazards (MIL-STD-882D),
are variations in the terminology used in different standards. (ii) requirement definition (MIL-STD-498), (iii) assessing
For example, MIL-STD-822C refers to ‘mishap’ and haz- the suitability of software components in the given hardware
ard risk assessment’ where Defence Standard 00-56 uses devices (EN 50128), and (iv) proving that software correctly
’accident’ and ’safety risk assessment’. In addition, there handle hardware faults (ESA ISVV Guide).
are also deviations between definitions commonly accepted e) RAMS Analysis: Only a minority of the studied stan-
by the academic research community. In the seminal paper dards define a proper methodology for these analyses, specif-
of Avizienis [14], we have the following definitions of the ically ISO 26262, EN 50126 and ECSS series of standards.
main concepts of safety: (i) Safety: absence of catastrophic Other ones suggest only on how performing hazard and risk
consequences on the user(s) and the environment; (ii) Fault: analysis, which covers only a part of RAMS analysis.
cause of an error; (iii) Error: deviation of the system from f) Safety Integrity Levels: With the exception of IEC
the correct behaviour; and (iv) Failure: event occurring when 60880 that has no reference to the safety integrity level
the delivered service deviates from correct service. concept, all the other standards include their own definition
If we consider the DO-178B standard, we find that an error for Safety Integrity Levels. IEEE 1012-2004 defines four
is assumed as a mistake in requirements, design or code, and levels of software integrity, and examples of classification
a fault is a manifestation of an error in software and may schemes are given based on the concepts of consequences
cause a failure (as also present in NASA-STD-8719.13). This and mitigation potential or on risk, but there is no assignment
is quite different from the previous definitions of Avizienis. method indicated since software integrity levels should result
On the contrary, with respect to the definition of safety, from agreements among the acquirer, supplier, developer, and
we have similarities: in IEC 61508, and derived standards, independent assurance authorities (such lack in the assignment
safety is assumed as freedom from unacceptable risk, which scheme is present also in DO-178B and EN 50126). Also
is slightly more subjective to the one reported by Avizienis, IEC 61508 specifies 4 levels, called Safety Integrity Levels
since it requires the definition of what can be assumed as (SIL), but on the contrary to IEEE 1012-2004 it contains a
acceptable risk, while Defence Standard 00-56 introduces in detailed description of the methods to be used in the Hazard
the definition also the concept of tolerable risks in addition to and risk assessment for SIL assignment. Defence Standard 00-
acceptable, clearly binding the definition to the performance 55 defines such levels in a more formal manner, making it a
of the fault-tolerance mechanisms adopted within the safety- measure of the required likelihood that a system achieves its
critical system. safety requirements, and requiring the construction of formal
b) Safety Life Cycle and Safety Management: The ma- arguments and statistical validation testing to provide a direct
jority of the selected standards introduce a complete safety measure of the safety integrity level.
life cycle, articulated into a series of activities, with a clear g) Risk Analysis: Neither MIL-STD-882D or MIL-STD-
indication on (i) when to commerce each of them during the 498 indicate how to perform risk analysis, IEEE 1012-2004
system life cycle, (ii) what kind of operations to perform, (iii) and DO-178B only specify when to perform it, and EN
which inputs to provide and (iv) which results to achieve. 50126 gives few details on how to perform it. But, all the
A concrete example is the IEC 61508. However, there are other standards provide guidelines and a set of methods to
standards, such as the DO-178B, that does not identify a support performing such analysis. If from one side, in IEC
specific safety life cycle, but only the production of several 61508 there is a great deal of subjectivity in conducting this
documents to prove the achievement of the safety goals. In analysis, NASA-STD-8719.13B and ECSS series of standards
the middle between these two extreme positions, we have describe rigorously its implementation. On one side, NASA-
standards, such as IEEE 1012-2004 or EuroCONTROL SAM, STD-8719.13B identifies in FMEA and FTA the systematic
that indicates a precisely articulated safety assessment process, top down deductive approaches to risk analysis. On the other
but do not insert it into a specific safety life cycle model. one, ECSS series of standards puts as core of the risk analysis

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data from all project domains (managerial, programmatic, providing objective evidence that software conform to require-
technical). ments, or in IEC 61508 for conforming that the requirements
h) Hazard Analysis: The standards that do not present have been fulfilled. However, most of the standards, even if
indications on how to conduct the risk analysis also do not with different words, specify a more detailed definition of
provide details on the implementation of the hazard analysis. verification, which provides also generic indications on how to
In general, standard recommendations with respect to hazard perform verification: evaluation of the results of a process to
analysis are less vague than risk analysis: ensure correctness and consistency with respect to the inputs
1) ISO 26262 states that hazards shall be systematically de- and requirements provided to that process (DO-178B).
termined, with techniques such as brainstorming, check- Less agreement we have found when describing on how to
lists, FMEA and field studies; perform verification:
2) EuroCONTROL SAM contains a detailed list of meth- • There is MIL-STD- 882D that provides no indication
ods to be used: 1) systematic application of a set of of a clear verification phase, only a series of activities
keywords to each function; 2) Brainstorming sessions; at the end of coding for assessing the quality of the
and 3) analysis of hazard database, accident/incident implemented software, i.e., unit testing (suggested also
reports, and lessons learned; by IEEE 1012-2004);
3) ECSS series of standards indicates that failure causes • EuroCONTROL SAM recommends to review and ana-
as identified through FMECA and other analyses, while lyze the results of the given process, but also checklists
hazard consequences can be determined with qualitative could be identified to support these methods;
methods, such as brainstorming, or even with more • ECSS series of standards proposes a well structured and
quantitative methods such as Fault Injection; documented process by suggesting tests, analysis, review
4) NASA-STD-8719.13B specifies that hazards and their of design and inspection;
causes are identified by using lessons learned, mishap • Other standards, such as ESA ISVV Guide, IEC 60880
data, analysis from similar systems, and engineering and EN 50128 (just to cite the main ones) contain
judgment; in addition to generic checklist with some long lists of methods to be used by discussing their
generic hazards, which represents a good starting place. characteristics and providing advices on when and how
Therefore, we can conclude that when detailed, the first using them, and upon which items.
methods for hazard analysis are qualitative methods such j) Validation: As done for verification, we have consid-
as brainstorming and analysis of historical data. Then, if ered in our analysis both objectives and implementation of
more accuracy is needed, quantitative methods are applied, validation, and we have notice divergence from the definition
where FMEA/FMECA is the preferred one. A surprising claim we provided in the introduction. Apart from MIL-STD- 498
we have found in the definition of hazard analysis within that does not provide any reference definition, some standards,
the context of the IEC 61508: “It may be quantitative or such as IEEE 1012-2004, define the objectives of validation
qualitative. However, the standard recognizes that, because as providing evidence that the software and its associated
software failure is systematic and not random, qualitative products satisfy system requirements, solve the right problem,
methods must be used only in the case of software”. By and satisfy intended use and user needs, which is a similar
definition, systematic failures are produced by human errors definition to the one presented in the paper. On the other hand,
during system development and operation, and it is indeed true other standards adopt a completely different formalization:
that the majority of bugs in software components belong to
1) ISO 26262: Provision of evidences on the absence
this category. However, studies within the context of software
of erroneous activation for safety mechanisms, and of
reliability have also identified an other kind of software bugs,
compliance to the safety goals;
named as Mandelbug [15], whose causes, activation and/or
2) DO-178B: Determination that the requirements are the
error propagation result so complex that its behavior appears
correct requirements and that they are complete;
random. This topic is still controversial, and there is a strong
3) EuroCONTROL SAM: Confirmation that the safety
debate around it, as [16] presents the reluctance of a part
objectives are (and remain) correct and complete, and
of researchers and industrial practitioners to acknowledge
ensuring that all critical assumptions are credible, ap-
uncertainty in failure occurrence. In our opinion, the reason of
propriately justified and documented.
this claim in IEC 61508 is due to the fact that it was theorized
at a time when software were quite simple and do not contain Also on the methods for implementing validation there is no
the source of non-determinism that we can find nowadays, agreement. Apart from some standards that do not indicate any
such as concurrent programming or heavy use of IO routines. specific method or implementation approach to use, such as
i) Verification: In our analysis of indications within the DO-178B, and MIL-STD- 498, standards typically provide a
context of verification, we have focused our attention towards list of methods to be used, as follows some practical examples:
two aspects: definition of the objectives, and implementation • IEEE 1012-2004 suggests integration testing;
of verification. The standards agree with our definition of • IEC 61508 indicates functional testing under environmen-
verification given in the introduction: Was the system built tal conditions, interference surge immunity testing, static
right? In fact, verification stands in IEEE 1012-2004 for and dynamic analysis;

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• ISO 26262 recommends (i) reproducible tests with spe- methods, while the other ones use them for (i) avoiding
cific procedure and pass/fail criteria; (ii) analysis (e.g., mistakes during requirement specification and inserting faults
FMEA, FTA, ETA, simulation); (iii) long-term tests; (iv) during design and development (IEC 61508), (ii) proving the
user tests under real-life conditions; (v) reviews; correctness of the system against a formal specification of
• EN 50128 mentions (i) probabilistic testing, (ii) perfor- its behaviour (ISO 26262), (iii) performing hazard and risk
mance testing, (iii) functional and black-box testing, and analysis (Defence Standard 00-55).
(iv) modelling; n) FMEA/FMECA: Only four standards do not suggest
• EuroCONTROL SAM considers (i) checklists to guide the use of FMEA, all the other ones make use of FMEA, and
validation process, (ii) operational or engineering judge- also FMECA when applicable, for identifying hazards, and
ment, (iii) tests through specific analysis, (iv) modelling providing evidence of the violation of safety goals.
or simulation, (v) review and analysis of the Safety o) FTA: In the standards that indicate FMEA/FMECA
Evidences to ensure their completeness and correctness. application in the safety assessment process, also FTA is
There are methods listed as usable for validation in one present. In some standards it is considered as alternative to
standard that we find listed for verification in another one. FMEA/FMECA, since same results are obtainable (e.g., IEC
A practical example is Unit testing, which is mentioned by 61508 or NASA-STD-8719.13B), in an other one, i.e., Defence
IEEE 1012-2004 as a verification mean, and by IEC 60880 Standard 00-55, FTA is used after performing FMEA/FMECA,
as a validation mean; FMEA or FTA as a validation mean in taking as inputs the results of the latter one.
ISO 26262 but as a verification mean in ESA ISVV Guide; or p) Discussion: Despite the several points in common
functional and block-box testing as a validation mean in EN among the different standards, i.e., all of them mention ver-
50128, but a verification mean in ESA ISVV Guide. ification and validation activities, testing as core method for
k) Fault Injection: Not all the selected standards suggest safety assessment and need of performing a risk and hazard
the use of fault-injection methods, despite representing a pow- analysis, there are serious differences that do not make them
erful technique for the evaluation of non-functional properties, interchangeable, and do not make it feasible to have a unique
such as fault-tolerance, of a software artefact [17], and it has standard able to substitute all the existing ones. It is our
been successfully used in several different application domains belief that such differences strongly depend on the specific
and kinds of hardware and software systems by academic application domain where the standard should be applied. This
researchers. Only four standards, out of the twelve analyzed is motivated by the need, and spent efforts, of standardization
ones, recommend its use: bodies to do not have only generic standards, such as IEC
• IEC 61508 consider it mandatory for validating fault-
61508; but to extend them to fit the characteristics and needs
tolerance mechanisms; of each application domain, such as in case of ISO 26262 and
• ISO 26262 enlists it as one of the methods for validation;
IEC 60880. The latter ones, even if derived from the same
• ECSS series of standards uses to assess mechanisms for
standard, exhibit differences among each others: ISO 26262
detecting, isolating and treating failures; presents Safety Integrity Levels while IEC 60880 does not;
• NASA-STD-8719.13B considers it as highly recom-
IEC 60880 does not specify a given safety life cycle, while
mended tests for safety-critical components. ISO 26262 does; or ISO 26262 suggests fault-injection while
IEC 60880 does not. Another evidence of this can be seen
l) Testing: It is widely used in all the analyzed standards:
in the consideration of hardware components in standards.
used in all the phases as in IEC 61508, in the RAMS analysis
The general approach is to consider their requirements when
as in EN 50126, or in the V&V process as in IEC 60880 or
software needs to be integrated with hardware, while ISO
ECSS series of standards. The difference among the standards
26262 disciplines development of both software and hardware
is what kind of testing methods are suggested:
components, and their successive integration. This is moti-
• IEEE 1012-2004 specifies software testing, software in- vated by the observation that in automotive domain, safety-
tegration testing, software qualification testing, system critical systems are represented by embedded systems where
integration testing, and system qualification testing; only in the recent years the amount of software is strongly
• EN 50128 suggest the use of stress testing, interface growing [18], and that traditionally the hardware side was the
testing, probabilistic testing, and integration testing; predominant one.
• NASA-STD-8719.13B contains a rich indication of the
testing methods to be used, among which the main ones IV. S TANDARDS E VOLUTION
are the followings: (i) black and white box testing; (ii) In these days, we are witnessing draft versions of two up-
unit testing; (iii) incremental integration testing; (iv) coming standards that summarize the efforts of standardization
functional testing; (v) system testing; (vi) regression bodies to update current standards to the evolution in terms
testing; (vii) acceptance testing; (viii) load and stress of implementation and technologies that current safety-critical
testing; (ix) performance testing; (x) security testing; systems are undergoing, and will have a strong impact on
(xi) alpha and beta testing. engineering these systems.
m) Formal Methods: Only IEEE-1012-2004 and MIL- DO-178C - Software Considerations in Airborne Systems
STD-882D/498 do not indicate explicitly the use of formal and Equipment Certification: The DO-178C includes a large

53
effort from industry and certification authorities and intends ACKNOWLEDGMENT
to fill the gaps, difficulties and to follow-up with modern This work has been partially supported by the project CRIT-
processes, technologies and tools. In fact, the consideration of ICAL Software Technology for an Evolutionary Partnership
recent software tools and technologies is a key addition to the (CRITICAL-STEP, http://www.criticalstep.eu), Marie Curie
RTCA standard, but the overall revision of the DO-178B stan- Industry-Academia Partnerships and Pathways (IAPP) number
dard cannot be ignored. The main intent behind the revision of 230672, within the context of the EU Seventh Framework
the body of DO-178B is to make it more focused and concrete Programme (FP7).
and avoid current ambiguities. For example, when talking
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