Control Sheet 24 (September 2015)

Control Sheet Cosylab’s Newsletter Volume 24

ISSN: 1855-9255

September 2015 Table of Contents

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ELI-NP: The Control System Is Getting Ready Cosylab is delivering the control system for the first stage of the ELI-NP Gamma Beam System on October 31st this year.

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A Path Through The Maze Of Medical Device Standards

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Audience Inspired at Laser and Accelerator Showcase

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We share our experience by giving an overview of the most important regulations and standards that must be followed when developing a medical device.

Partner News from the Symposium on Lasers and Accelerators for Science & Society

The Picture Board A reader-submitted picture.

Cosylab d.d., Teslova ulica 30, SI-1000 Ljubljana, SLOVENIA Phone: +386 1 477 66 76 Email: controlsheet@cosylab.com URL: www.cosylab.com

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ELI-NP: The Control System is Getting Ready By : Anže Jesenko (Cosylab) and Gašper Pajor (Cosylab) Cosylab is delivering the control system for the first stage of the ELI-NP Gamma Beam System on October 31st this year.

The ELI-NP GBS The ELI-NP project [1, 2], currently under construction in Magurele, Romania, is a part of the Extreme Light Infrastructure (ELI) family [3]. It will consist of two large machines; a very intense Compton backscattering gamma beam source and a very high intensity laser. Once complete, the ELI-NP will be the most advanced laser and gamma beam facility in the world.

The gamma beam system (GBS) will be delivered by the EuroGammaS consortium which is headed by the Italian Institute of Nuclear Physics (INFN). Institutes and companies from all across Europe are participating in this consortium and Cosylab assumed responsibility for delivery of the overall control system.

Tackling the NonTechnical Control System Challenges The timeline of the ELI-NP GBS installation and commissioning stretches all the way to 2018/2019 and is segmented into different stages. The timeline for delivering and installing the control system, however, is considerably shorter.

Once the first stage of equipment is installed on-site, the control system has to be operational as soon as possible, so that equipment can be used in commissioning of that particular accelerator segment. As with most accelerators, the controlled devices of ELI-NP GBS repeat along the beam path. This means the control system needs to support all the different devices right from the initial stages. If the control system is designed properly, it then just incorporates more instances of the same device types further along the way.

The tight schedule imposed by the fact that

Figure 1: The devices we are delivering were thoroughly tested.

most of the control system must be ready early on is further tightened by a multitude of partial delays common to such large projects – decisions on hardware, discussions on different use cases, hardware lead times and so on. And while developing the control system, most of these things must be resolved before the development of a particular control system part can be finished – or in some cases even started.

To mitigate this, Cosylab joined the project at the beginning and has been actively collaborating with other EuroGammaS consortium members. In this way, we managed to prevent the control system, as is often the case, from becoming a marginal thing that nobody thinks about until its absence starts inducing installation and commissioning delays.

We took a turn-key approach to providing the ELI-NP GBS system, where design is

defined upfront and expectations towards numerous consortium partners are clearly stated and followed. Control system components were developed and tested after a brief but tremendously important period of requirement gathering and use case discussions, intended to get the attention, commitment and eventually agreement of all involved parties. Such an approach will enable us to deliver a coherent and tested control system in time to support the installation and commissioning. Furthermore, the delivery of a turn-key control system early on will enable a smooth transition into the operations period.

Getting Ready for the Acceptance Test The control system has been running for quite some time in our rack room. In-depth testing and debugging of all subsystems was done together with EuroGammaS

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Next Stop: Magurele, Romania The team is looking forward to the on-site installation beginning in 2016. We are well prepared for the task awaiting us, we wish all the best to everybody involved in this project in Romania!

ABOUT THE AUTHORS Anže Jesenko is a software engineer at Cosylab, joining in 2010. He has a lot of experience with integration and installation of accelerator control systems. He is responsible for the acceptance of the first stage of the ELI-NP GBS control system. In his free time he enjoys cooking and eating Mediterranean / Asian / Indian food.

Figure 2: The ELI-NP Gamma Beam System control room will feature 6 operator interface computers.

consortium members. Right now we are pushing hard to make sure that every little piece of the puzzle is in its proper place.

Apart from control system software, our deliverables include IOC computers for distributed control, the precision timing and triggering system and the full control room, everything of course along with the necessary documentation and test protocols.

For the IOCs we chose the 3U Compact PCI (cPCI) form factor with 64-bit Intel Core i7 processors. This hardware is readily available and is supported by existing software.

It will easily handle any task assigned to it for years to come.

Gašper Pajor is a Group Leader at Cosylab, joining in 2001. He has a background in physics, with extensive experience in project management of control system projects. Currently, he is the project leader for the ELI-NP turnkey control system that is responsible for delivery of the overall control system for this project. In his free time, Gašper enjoys spending time with his family in his house in the countryside they just moved into.

NP GBS team has been preparing for this from the design phase onward. We strived to streamline installation and system configuration. The result makes it possible to REFERENCES install all software related to an IOC and simultaneously configure the system with a [1] http://www.eli-np.ro/ single install command.

[2] http://www.stfc.ac.uk/3122.aspx

Not only will this speed up installation, [3] http://www.eli-laser.eu/ but it will also reduce downtime in case of [4] http://www.eli-np.ro/civil-construction/ hardware failure. construction_photos.php

The control room will feature 6 operator interface computers, each with its own 4-monitor setup and one more operator console displaying status on wall-mountable big screens. Any of these computers will be able to control and monitor any aspect of the accelerator, from the timing system to fluorescent screen cameras.

Matlab and other tools will be available to engineers and scientists for a multitude of uses.

Ease of Installation, Ease of Maintenance With a flood of tasks during installation, it is easy to miss something. The Cosylab ELI-

Figure 3: Construction site of ELI-NP, photo courtesy of ELI-NP, Romania. [4]

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A Path Through the Maze of Medical Device Standards By : Jernej Plankar (Cosylab) and Marko Mehle (Cosylab)

The times when particle accelerators were merely scientists’ toys are long gone. As medical science is discovering new ways of treating complex diseases like cancer, particle accelerators are beginning to play a major role in these therapeutic processes.

Introduction To fulfill its purpose of providing therapy, a therapy particle accelerator must be a machine that is safe enough to be used for medical treatment. This means that it must comply with the requirements defined by the Laws and Regulations that apply to medical devices; the requirements are normally further detailed within Standards.

Having gained relevant experience from developing big physics control systems, Cosylab started focusing on the production of medical system software and hard-

ware for accelerator based radiotherapy systems in 2013. We also established (in 2011) and currently maintain ISO 13485 [1, 2]. ISO 13485 specifies the requirements for a quality management system for the design and manufacture of medical devices.

In this article, we share some of our experience by giving an overview of the most important regulations and standards that apply when developing a medical device.

tions, Standards and Guidelines and when is each applicable? Figure 1 illustrates that Regulations are at the very highest level and usually apply at the national or even international level. Then, from an implementation point-of-view, there are Standards that apply to either “Management and Processes” or to “Products”. Finally, there are Guidelines. All of these elements are closely connected.

Regulations, Standards and Guidelines

General Regulations

What are the differences between Regula-

The Regulations that a medical system must comply with depend on the coun-

Regulation (i.e. MDD 39/42/EEC)

National regulation (national laws)

Management and process standards

   

Guidelines

ISO 13485 Quality management

GHTF decisions, NBOG decisions, MEDDEV, ...

ISO 14791 Risk management IEC 62304 Software lifecycle processes

Product standards IEC 60601: General safety standard for medical electrical equipment Collateral standards:  IEC 60601-1-1: Medical electrical systems  IEC 60601-1-2: EMC  IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment  IEC 60601-1 (section 14): PEMS  IEC 60601-1-6: Usability  ...

Particular standards (IEC 60601-2-X)

Recommended Mandatory

IEC 62366: Usability engineering ISO 10993-X: Biocompatibility

Other

Figure 1: Overview of Regulations, Standards and Guidelines

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Figure 2: Mechanical stress testing (SIQ laboratory)

try (or region) where the accelerator will operate. For example, all countries in the European Union (EU) incorporate the provisions of the European Medical devices Directive 93/42/EEC [3] into their domestic law. Regulations may reference international standards (e.g. IEC 60601-1 [4]) or they may even adopt them (e.g. EN 606011 in the EU, GB 9706.1-2007 in China or ANSI/AAMI ES60601-1 in the USA). Compliance with the referenced standards creates presumption of conformity with regulatory requirements. Whether it is an item for mass consumption or a custom designed product, in order to place it on the market, the manufacturer needs to ensure that all applicable requirements are met.

In general, when it comes to the safety of an electrical medical device, one needs to consider the use of IEC 60601-1 [4] – normally the latest edition needs to be considered, including all amendments. IEC 606011 is a product standard, listing concrete technical requirements and describing the methods to test and prove their fulfilment.

The standard applies to a physical device, which means that the final device will be tested and can be certified according to the requirements of this standard.

System Requirements IEC 60601-1 is a technical standard covering system design and manufacture of

medical systems, but It imposes requirements on the manufacturing quality management system (Figure 1). It does this by referencing the system standard, ISO 13485 [1] that presents the process requirements for design, development and production of medical systems. The ISO 13485 system standard itself does not deal with concrete devices and technical limits, it describes the quality processes.

Setting up the ISO 13485 standard on a company level is a process that can take a long time since it is necessary to adapt the processes and infrastructure to the standard requirements.

The establishment of the quality management system and its maintenance on a company level are evaluated by competent bodies legally designated to perform this task (e.g. SIQ [5]). Compliance is assessed by various audits, which also include documentation assessments. Furthermore, internal (manufacturer) audits are mandatory.

The standards are documentation intensive – they demand thorough documenting of all processes. In addition to the processes, comprehensive documentation is also required to be prepared and maintained for each product in the form of a technical file.

The documentation traceability must be ensured at all times and quality and prod-

uct related documents must be retained during the entire product lifetime.

Accompanying documents (e.g. Instructions for use) are mandatory and should provide the user with all the information, required by the Standard. Operation description, detailed installation instructions, use environment, safety precautions and warnings, advisory notices, explanations of markings and maintenance procedures are only a few of the necessary content.

“What can go wrong?” – Risk Management Process One of the regulations and key requirements of ISO 13485 is the establishment of a risk management process (ISO 14971 [6]). In order to commence the risk management process, the manufacturer has to identify the product’s essential performance (EP). This term is defined by the standard as the performance necessary to achieve freedom from unacceptable risk.

The 13 steps of risk management, as defined by ISO 14971, can be summarized by three main groups of activities: ◊ Risk assessment (identification of hazards and their effect estimation, decision whether risk control is needed) ◊ Risk control (evaluation of risk mitigation options, implementation of mitigation measures to reduce the risks, residual risk assessment, risk/benefit

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Performing the risk management process properly is an iterative process, which considers everything down to the last detail. It starts early during the concept and requirement identification phase and is maintained throughout design, implementation, testing and even post-market phases.

The outputs of the risk management have to be aligned with each of the design, development and production phases.

Specific Requirements for Devices So far we have given an “in-a–nutshell” overview of the processes that need to be established before product development can begin. These processes need to be followed throughout design, development and manufacture and even after. Yet as IEC 60601-1 is ultimately a product standard, let’s look at some of its specific requirements in regards to the design of a medical system.

It is vital to clearly describe the intended

Control Sheet use of the medical system, define the use environment and user profile and keep these consistent throughout the documentation. Many requirements depend on these definitions.

The power supply plays a crucial role in medical system testing and certification.

Its design must be planned and tested according to the standard. For example, the isolation between the a.c. input to the power supply, high voltage stages and the d.c. output must prevent electric shock to the patient or operator. All power supply insulation will face rigorous testing at much higher test voltage levels than it faces during normal operation; a 230-V a.c. rated power supply must withstand a dielectric test at 4 kV a.c. Touch current levels (leakage paths from an enclosure that may come into contact with a patient or operator) are 100 μA for normal operation and 500 μA for a single fault condition.

The device must also incorporate one or more means of protection (MOPs) to prevent risk of electrocution to the patient or operator. A MOP can be a safety insulation, protective earth, defined creepage distance, air gap or any other protective impedance. Test levels depend on further classification – means of patient protection (MOPP) and means of operator protection

Figure 3: Radiated emission testing (SIQ laboratory)

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ISSN: 1855-9255 (MOOP). The choice is the manufacturer’s responsibility and depends on intended use, environment and user profile, etc. [79].

The enclosure is normally considered a critical component and it also requires a careful design. A ground equalization pin must be incorporated and marked (this is also a MOP). Markings on the enclosure are strictly defined in terms of content and symbols used, to ensure that the user will handle the device appropriately, avoiding the risk of abnormal use and use errors.

Not to be neglected is product packaging. Safety warnings and storage/transport conditions must be clearly stated by using standard symbols. The standard advises to conduct packaging validation testing (IEC 60721-3-2 [10]) to verify the degree of the device’s immunity to environmental (mechanical, temperature and humidity) influences (Figure 2). Similar tests are advised for equipment under operation.

These conditions are less demanding, but the equipment has to sustain them during operation.

The risk management process is closely intertwined with satisfying the product standard requirements.

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Collateral Standards Collateral standards (IEC 60601-1-X) are to be taken into account as applicable. Furthermore, they can even take priority over the general standards (IEC 60601-1), but can also be “overridden” by requirements of a particular standard, if it exists, for a specific device. One collateral standard currently exists for light ion-beam medical equipment: IEC 60601-2-64. Collateral standards can greatly influence the design and implementation of medical systems.

Electronic devices radiate and are susceptible to electromagnetic (EM) waves and electrostatic discharges (ESD) in their vicinity. This is especially true in the data centers and equipment rooms of particle accelerators where many devices are housed and connected. Immunity to electromagnetic interference often proves inadequate during certification testing. It is crucial that the medical system is built with that in mind from the beginning. Immunity tests are defined in a collateral standard, IEC 606011-2 [11], that takes into account electrostatic discharge, supply voltage dips and variations, magnetic fields, radio frequency interference and other EM phenomena.

Additionally, testing and measurement techniques are defined in IEC 61000-4-X. IEC 60601-1-2 defines EM emission levels which the system shall also not exceed.

This is also subject to testing. An example of emission testing is shown in Figure 3.

Software design plays an important role in the certification procedure. IEC 60601-1 (section 14) and IEC 62304 [12] address this aspect. Validation of basic design quality, responses to unexpected events and code coverage are taken into account during testing. The tricky thing is that sometimes it is not clear whether our system must comply with the standard. Of course, if there is a processing unit involved we need code to drive it, but what about programmable hardware (e.g. FPGA and CPLD)? Since no clear guidelines are currently available, it is the manufacturer’s choice to treat the subsystem as “gateware” (hardware) or as a Programmable Electrical Medical system (PEMS). An interesting insight on this topic can be found in [13].

Another aspect of a medical system is its usability (covered by the collateral stan-

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dard IEC 60601-1-6 [14] and its extension, IEC 62366 [15]). Special care is needed to design the entire system in a way that makes it user friendly, not forgetting the user-interface. This needs to be designed in a way that minimizes errors. The definition of the intended user profile can be a contentious topic, especially when designing a custom made system for a specific client. Usability shall be validated (and documented) by the manufacturer.

[6] ISO 14971:2012, “Application of risk management to medical devices”

A company can claim a certification mark (e.g. CE in the EU, UL in the US, etc.) for the product and release it on the market only after this product has demonstrated compliance with all applicable safety and functional requirements by passing the required tests.

[10] IEC 60721-3-2:1997, “Classification of environmental conditions”

Conclusion

[12] IEC 62304, “Medical device software – Software life cycle processes”

To comply with the requirements defined by the Laws and Regulations that apply to medical devices, a manufacturer must have the necessary quality and risk management processes established and must rigourously follow them. This is complex and time-consuming, and one can easily get lost in the maze of Regulations and Standards.

Rest assured, if ever the challenge of medical certification crosses your path, Cosylab is there to take the weight from your shoulders, ranging from friendly advice to realizing your entire medical accelerator control system!

REFERENCES [1] ISO 13485:2012, “Medical devices – Quality management systems – Requirements for regulatory purposes” [2] Cosylab ISO 13485 certificate, http://www. cosylab.com/references/quality_system_ certification/iso_13485_2003 [3] Medical devices Directive 93/42/EEC, http://eur-lex.europa.eu/legal-content/ EN/TXT/?uri=CELEX:31993L0042, 2015 [4] IEC 60601-1: 2005 + A1:2012, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance” [5] SIQ, http://www.siq.si/

[7] http://www.digikey.com/en/articles/techzone/2011/sep/power-supply-requirements-for-medical-applications [8] http://www.cui.com/catalog/resource/iec60601-1-medical-design-standards.pdf [9] http://www.electronicsweekly.com/news/ medical-electronics-2/know-your-moppsfrom-your-moops-is-medical-powersupply-design-2013-11/

[11] IEC 60601-1-2:2007, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests”

[13] http://blog.cm-dm.com/post/2013/04/04/ IEC-62304-vs-IEC-60601-1-and-IEC-61010 [14] IEC 60601-1-6:2007, “Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability” [15] IEC 62366:2007, “Medical devices – Application of usability engineering to medical devices”

ABOUT THE AUTHORS Jernej Plankar received his degree in Electrical Engineering from the Faculty of Electrical Engineering at the University of Ljubljana in October 2014. In 2015 he joined Cosylab where initially he worked as a software developer on the HIMM (IMP, China) project. Later he joined Cosylab’s medical team as a HW developer/ technical writer on the MedAustron (Austria) project. His hobbies include playing guitar and racket sports.

Marko Mehle has a background in Electrical Engineering and started working at Cosylab in 2011 where he is involved with LabVIEW development and integration, FPGA development, hardware architecture, documentation and standards. He is currently working as a Project Manager & Senior Hardware Engineer and contributes to the ESS (Sweden) project as well as to CS integration and medical device development at MedAustron (Austria). In his spare time, Marko writes (words and music) and plays the latter.

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PartnerNews

Audience Inspired at Laser and Accelerator Showcase Cosylab is a partner in the oPAC network, which aims at developing long term collaboration and links between the involved teams across sectors and disciplinary boundaries and thus help to define improved research and training standards. Specifically, Cosylab is involved in the WP7 work package, namely Control and Data Acquisition Systems.

Figure 1: Speakers and delegates at the Symposium on Lasers and Accelerators for Science & Society

An international Symposium on Lasers and Accelerators for Science & Society [1] took place on the 26th of June in the Liverpool Arena Convention Centre. The Symposium was coordinated by Prof. Carsten P. Welsch of the University of Liverpool and the Cockcroft Institute in Daresbury, an internationally renowned centre for accelerator science and technology. The event was a sell out with delegates comprising 100 researchers from across Europe and 150 local A-level students and teachers. The aim was to inspire youngsters about science and the application of lasers and accelerators in particular.

‘Discovering the unknown’, ‘innovation’, ‘beating cancer’, ‘pioneering new technology’, ‘a possible career’ – these were comments from sixth-formers, who among

researchers, students and general public, attended the Symposium.

It is now possible to share their enthusiasm through online presentations [2], which includes talks from renowned scientists such as Professor Victor Malka (LOA, France), Dr. Ralph Aßmann (DESY, Germany) and Professor Brian Cox (University of Manchester, UK), best known to the public for his television programmes about the origins of the universe.

The Symposium also showcased a portfolio of projects from researchers at the forefront of this exciting field of science and engineering through an interactive poster session with questions and answers, giving young people the opportunity to see how scientists just a few years older than themselves are pushing back the boundaries of

knowledge.

Accelerator science has applications across all sectors of industry and healthcare, allowing us to accurately target cancer tumours, understand the structure of biomolecules such as proteins and complex chemicals, measure strain in jet engines, create new materials and understand the secrets of the universe itself.

Organiser Professor Carsten P. Welsch, Head of the Liverpool Accelerator Physics Group at the Cockcroft Institute in Daresbury, leads two pan-European training networks which aim to address the skills shortage in accelerator science.

Prof. Welsch explains: “This discipline offers enormous opportunities for scientific discovery but also professional development.“

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Volume 24 “Research Fellows from the training networks oPAC (optimization of particle accelerators) [3] and LA3NET (lasers for applications at accelerator facilities) [4] have in three years become experts in their discipline but also have developed skills in physics, engineering, IT, data analysis and project management.”

“The involvement of partners from industry and academia and the opportunity to work at research institutions across Europe has provided training that would be impossible by one company or one country alone.”

The training has been recognised by the European Commission as an international “success story” as part of formal project reviews and is amongst the very best research and training programmes in the world.

In addition to the Fellows’ poster session top scientists gave presentations to demystify this area for more people.

Professor Grahame Blair, Executive Director of Programmes for the Science and Technology Facilities Council (STFC), explained how particle accelerators can be used as research tools. He explained that particle accelerators can recreate the conditions of the Big Bang, making it possible to test fundamental theories about the universe.

He says: “The Large Hadron Collider at CERN enables us to create unique conditions not seen anywhere else on Earth and it was successful in allowing us to test many of the most advanced theories. In the process we are also learning about how to create high-energy particle beams and control them effectively. This is where beam diagnostics are important; by developing these tools the technology can be used in other applications.”

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ISSN: 1855-9255 accelerators to large scale facilities. In Liverpool, he presented the results of his research with a poster on the DCDB-tool (Device Control DataBase tool) [5] – a control system configuration tool he has been developing in the course of the oPAC training programme at Cosylab. This software suite provides an easy-to-use interface for quick configuration of an entire facility.

The presentations from the Symposium are now edited and available online [2], providProf. Blair explains that accelerators are ing a unique introduction to this fascinatused to create x-rays for use in material sci- ing area of science and technology. ence, chemistry and biology and that the Diamond Light Source was used, for example, to fast-track the development of a new type of vaccine during the foot and mouth disease outbreak. Access to this technology REFERENCES and skills is creating a cluster of high-technology companies at Daresbury working in [1] https://indico.cern.ch/event/368273/ this field and creating exciting career op- [2] http://www.liv.ac.uk/quasar/symposium/ portunities for young people.

Paul Taylor, Head of Physics at Merchant Taylors’ School, commented that the event had been inspiring for his students, many of whom are now considering studying physics at Liverpool or Manchester universities.

Cosylab’s oPAC Fellow, Pavel Maslov, is working on an adaptation of existing opensource control systems, from compact

Figure 2: Cosylab oPAC Fellow, Pavel Maslov

[3] http://www.opac-project.eu/ [4] http://www.la3net.eu/

[5] http://users.cosylab.com/~pmaslov/dcdb/

What to do if your kids suddenly show an interest in your Cosylab T-shirt...

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Cosylab d.d., Teslova ulica 30, SI-1000 Ljubljana, SLOVENIA Phone: +386 1 477 66 76

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