General Safety Requirements Research Articles

On the issue of the development of legislative and regulatory provision of the radiation safety of the public

After the publication of ICRP Publication 103 in 2007 and IAEA Basic Safety Standard “Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards. General safety requirements Part 3” in 2014, there is an ongoing process in the Russian Federation on the harmonization of the norms of the radiation safety and basic rules on the provision of the radiation safety with the international requirements. According to the Decree of the President of the Russian Federation № 585 “On the establishment of the basis of the governmental policy in the field of the provision of nuclear and radiation safety in the Russian Federation in the period up to 2025 and the future perspective” and the Plan of the execution of the “basis of the governmental policy…”, approved by the Decree of the Government of the Russian Federation №139-r, 02.02.2019, a work has been initiated on the development of the changes and additions into the Federal State Laws № 170-FZ “On the use of the nuclear energy” and № 3-FZ “On the radiation safety of the public”. For the successful execution of the mission it is necessary to develop joint inter-agency workgroups with the parallel development of the changes and additions to the № 170-FZ. №3-FZ, NRB and OSPORB.

Comparative study of nuclear post-accident management doctrines in Europe and North America

The French Nuclear Safety Authority (ASN) issued in 2012 a first version of a doctrine establishing the principles of management of a post-accidental situation following a major nuclear accident. Since this publication, the feedback of the Fukushima-Daiichi accident continued and numerous evolutions occurred, both in French and European regulations and in international recommendations from IAEA and ICRP. This had led to further developments in the French doctrine for management of a post-accidental situation. This will result in the publication of a new version of the French doctrine next year. This evolution also prompted questioning about the existence of such doctrines in other countries, especially in neighboring countries. It appeared also interesting to evaluate the agreement of these doctrines, including the French one, with international recommendations, especially the recently published general safety requirements (GSR), part 11, from IAEA. A benchmark study comparing the different post-accidental management doctrines available was then conducted and is presented here.

Severe accident analysis of the dual-functional lithium-lead test blanket module using ISAA-DFLL code

The international thermonuclear experimental reactor (ITER) project aims to build a tokamak fusion test reactor to verify the feasibility of fusion reactors. The test blanket module (TBM) is the key component of the international thermonuclear experimental reactor. The fusion design study team proposed the concept of the dual-functional lithium-lead test blanket module (DFLL-TBM). The integral severe accident analysis (ISAA) is a self-developed ISAA code that models the progression of severe accidents in nuclear power plants. A broad spectrum of severe accident phenomena including fission product release and transport behavior is modeled in ISAA. In this paper, a new version of ISAA, referred to as ISAA-DFLL is introduced for the application of DFLL-TBM test blanket module into the treatment of multi fluids and the modules of the new physical property and heat transfer. The modification is verified by comparing the steady-state temperature distribution of the DFLL-TBM first wall with the design parameters. Then accident analysis of In-vessel loss of helium coolant in first wall and TBM pipe is conducted by using the ISAA-DFLL code. By comparing the calculation results with the general safety requirements for TBM, it is concluded that the design of the DFLL-TBM system and the modifications of the current version are reasonable and accurate.

How does subsea processing safety policy impact safety? Lessons learned from the Brazilian experience

This paper is about the influence of safety regulations on the way major accidents are identified and managed. A case study is presented based on the Brazilian experience in subsea processing units. The oil and gas industry is devoting increased interest to subsea processing due to the limitation of easily accessible oil and gas reservoirs. There are more than 48 units already installed in Brazil. Most of the safety requirements in Brazil's E&P policy are based on offshore units. However, for subsea structures, there are different risks, environments, and operational conditions. In 2015, Brazil presented a safety regulation named SGSS (Technical Regulation of Operational Safety Management System of Subsea System). This regulation explicitly addresses risers and introduces only general safety requirements to other subsea installations and equipment. Thus, this paper assesses the Brazilian subsea safety regulation and the results of this policy implementation through the Brazilian Petroleum Regulator (ANP) inspections and incident communications. The example demonstrates the inefficiency of the policy to promote safety. This paper then proposes simplifying regulations, introducing new technology requirements, and a technical committee to improve safety to subsea equipment.

The Fukushima nuclear accident that occurred a decade ago has been considered a major accident

The Fukushima nuclear accident that occurred a decade ago has been considered a major accident. In this decade period, various important aspects of this accident were considered well-established for learning to improve nuclear safety infrastructure and prevent similar major accidents. The learning is very relevant for Indonesia, which is considered as an embarking country. Thus, this paper aims to assess the lessons that have been and can be learned by Indonesia from the nuclear accident. This study applies an analytical, descriptive and qualitative methodology using secondary data. In the first step, the important aspects of safety in the accident were identified applying the IAEA general safety requirement standards. The next step is the identification of relevant topics for each of these aspects in order to detail the lessons learned through an analysis of existing laws and regulations and international standards. This paper concludes that Indonesia has learned the lessons from the Fukushima nuclear accident in the aspects of international agreements, regulatory principles, and in accident prevention and mitigation. However, Indonesia still needs significant upgrading in the aspect’s leadership for safety and improvements in all these aspects. If a national decision has been made to build nuclear power plant, then these upgrading and improvements must be made to prevent a large-scale nuclear accident as happened at the Fukushima nuclear power plants.

Online interventions to prevent mental health problems implemented in school settings: the perspectives from key stakeholders in Austria and Spain

BackgroundSchools are key settings for delivering mental illness prevention in adolescents. Data on stakeholders’ attitudes and factors relevant for the implementation of Internet-based prevention programmes are scarce.MethodsStakeholders in the school setting from Austria and Spain were consulted. Potential facilitators (e.g. teachers and school psychologists) completed an online questionnaire (N=50), policy makers (e.g. representatives of the ministry of education and health professional associations) participated in semi-structured interviews (N=9) and pupils (N=29, 14–19 years) participated in focus groups. Thematic analysis was used to identify experiences with, attitudes and needs towards Internet-based prevention programmes, underserved groups, as well as barriers and facilitators for reach, adoption, implementation and maintenance.ResultsExperiences with Internet-based prevention programmes were low across all stakeholder groups. Better reach of the target groups was seen as main advantage whereas lack of personal contact, privacy concerns, risk for misuse and potential stigmatization when implemented during school hours were regarded as disadvantages. Relevant needs towards Internet-based programmes involved attributes of the development process, general requirements for safety and performance, presentation of content, media/tools and contact options of online programmes. Positive attitudes of school staff, low effort for schools and compatibility to schools’ curriculum were seen as key factors for successful adoption and implementation. A sound implementation of the programme in the school routine and continued improvement could facilitate maintenance of online prevention initiatives in schools.ConclusionsAttitudes towards Internet-based mental illness prevention programmes in school settings are positive across all stakeholder groups. However, especially safety concerns have to be considered.

How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

Abstract The Corona Virus Disease 2019 (COVID-19) pandemic has demonstrated that the ability for laboratories to quickly set up and implement labdeveloped tests (LDTs) is essential to respond to an emerging health crisis. The Regulation on in vitro diagnostic medical devices (IVDR) could, however, profoundly impact our ability to respond to a future pandemic since the IVDR could significant restrict the use of LDTs. We address using the example of the current pandemic a number of LDT implementing issues problems which should be addressed. We conclude that the COVID-19 pandemic illustrates that commercial tests cannot cover all patient needs under any given circumstance and that sufficient degrees of freedom for laboratories to ensure their expertise to develop and implement LDTs ultimately benefit European citizens.

Companion Diagnostics: State of the Art and New Regulations.

Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.

REDUCTION OF LOCAL VIBRATION ON THE TILLER OF AN OUTBOARD MOTOR USING A TRANSOM MULTI-LAYER VIBRATION PAD

The article deals with the measurement and reduction of local vibration from outboard motors on small vessels. The level of local vibration on the tiller of an outboard motor of a small vessel according to GOST 28556-2016 "Outboard Motors. General safety requirements" should be specified in the motor operating instructions, but, according to the authors ' analysis, such information is not specified by manufacturers. To measure the vibration, modern verified equipment was used, including the "Ecofizika-110A" vibrometer. To reduce the vibration of outboard motors, the authors developed a multi-layer transom plate and carried out measurements on a motor boat with outboard motors "SEA PRO 2.5" and "SEA PRO 5.0". As a result of the study, it was found that the developed multi-layer transom overlay provides a maximum reduction of local vibration by 77% when measuring vibration acceleration, m/S2. It is also established that in Russia there are actually no regulatory requirements for the level of vibration on the tiller of outboard motors, while the system provided for in GOST 28556-2016 "Outboard motors. General safety requirements" standard of manufacturing plants, most often not specified in the actual operating instructions. This requires the development and introduction of standards for local vibration on the tiller of outboard motors or the expansion of existing regulations in the field of small vessels.

Risk Assessment of Food Contact Materials.

Food contact materials (FCM) can contain chemicals that could migrate from the material itself to the foodstuff posing health concerns if ingested in non‐safe quantities by the consumer. FCM include containers, packaging, machinery or kitchenware and can be made from different materials like plastics, paper and board, metal or glass. Printing inks are also an important part of FCM. FCM have an important role in preventing damage or spoilage of the foodstuff and are essential along the food chain. Therefore, their safety needs to be carefully assessed in order to reduce the exposure to potentially hazardous substances and protect the health of the consumer. At the EU level, the legislation on FCM establishes general safety requirements for FCM. In addition, for certain materials, specific measures concerning usage and release of substances have been set. For materials or articles not specifically regulated in this harmonised framework, safety must be proven on a case‐by‐case basis. National legislations and lists of substances evaluated by competent authorities are important data sources in this context. One of the most important databases are the ‘BfR Recommendations on Food Contact Materials’ and the soon to come German national regulation on printing inks. BfR Unit 74, besides dealing with chemical risk assessment of FCM, is responsible for the evaluation of application dossiers for including substances into the BfR recommendations on FCM or the substance list of the printing inks regulation. Through the proposed work programme the fellow has been involved in risk assessment of substances that migrate from FCM into foodstuff gaining experience in the methodologies used to perform the scientific data evaluation as well as to support the BfR Unit 74s work.

Разработка типоразмерного ряда неполнооборотных электроприводов

Specialists of NII Transneft LLC and TOMZEL JSC were tasked with developing a standard-size range of partturn electric drives with an electronic control unit for ball shutoff valves in order to arrange the Russian production of this type of equipment. When determining the requirements for the developed valves, the features of the operation of foreign-made part-turn electric drives were taken into account. New developments had to meet general technical requirements, safety and ergonomics requirements for electric drives operated in oil and petroleum products pipeline transport facilities. When elaborating technical solutions, an analysis of thematic publications, international and Russian regulatory documents, technical characteristics of domestic and imported drives, existing solutions for the layout of electric drives with electronic control units has been accomplished. As part of the R&D work, optimal design solutions have been found taking into account the actual operating conditions of the equipment, design documentation has been developed for the standard-size range of part-turn electric drives, prototypes have been manufactured, and their preliminary and acceptance tests have been accomplished successfully.

The Activity Concentration of Radionuclides (226Ra, 232Th and 40K) in Soil Samples and Associated Health Hazards in Natore, Kushtia and Pabna District of Bangladesh

The study has been carried out to measure the activity concentration of natural and anthropogenic radionuclides in fifteen(15) soil samples of Natore, Kushtia and Pabna district, which are around the 30 km peripheral area of Rooppur Nuclear Power Plant, by gamma ray spectrometry system using a High Purity Germanium (HPGe) detector. It is found that the activity concentration of 226Ra, in the collected sample was from 3.52 Bq/kg to 28.5 Bq/kg with the average value of 12.42 Bq/kg. For 232Th, the range was from 4.18 Bq/kg to 34.5 Bq/kg with the average value of 12.6 Bq/kg. Finally, the activity concentration of 40K, in the collected sample was in the range of 84 Bq/kg to 345 Bq/kg, and the average value was 198.9 Bq/kg. The absorbed dose rate (D) was found to be in the range of 4.59 nGy/h to 40.93 nGy/h with the mean value 21.3 nGy/h. The annual effective dose (E) was in the range of 0.006 mSv/yr to 0.152 mSv/yr with an average of 0.033 mSv/yr. The radium equivalent activity was in the range from 10.02 Bq/kg to 89 Bq/kg with an average of 44.99 Bq/kg. The external hazard index (Hex) was found to be in the range of 0.027 to 0.242 with the mean value of 0.121 and the internal hazard index (Hin) was found to be in the range of 0.044 to 0.302 with the mean value of 0.156. All the values are much below the recommended limit by the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), 35 Bq/kg for 226Ra, 30 Bq/kg for 232Th and 400 Bq/kg for 40K. According to international and national regulation, the annual dose to members of the public, 1 mSvy-1 and Hex & Hin must be lower than unity. Moreover, no artificial radioactivity was found in the soil samples of this study area. This research concludes that the found values are within the permissible limits as required by the Nuclear Safety and Radiation Control(NSRC) Rules-1997 of Bangladesh and International Atomic Energy Agency(IAEA) Safety Standards- General Safety Requirements (GSR): Part-3.
 Journal of Bangladesh Academy of Sciences, Vol. 43, No. 2, 169-180, 2019

Safety of Imported Machines - Selected Issues in the Context of Polish (UE) Regulation

Abstract The purpose of the paper is to present the issues of ensuring the safety of machinery and equipment in accordance with the requirements of the Machinery Directive 2006/42/EC of May 17, 2006 on the essential requirements for machines, with regard to the sphere of their import and distribution. This issue is related to the dynamically developing trade in cheaper new machines, mainly from countries outside the EEA (including China) and is a priority for ensuring safety and protecting the health and life of users of this type of equipment in accordance with EU regulations. The use of a variety of machines in industry, in addition to general safety requirements, which may also include quality criteria, care for the environment and industry-specific safety management requirements (e.g. food, automotive, medical devices).

Regional Workshop on Lessons Learned Applying the IAEA General Safety Requirements Part3

Regional Workshop on Lessons Learned Applying the IAEA General Safety Requirements Part3

Application of standardization for the design and construction of carbon nanotube-based product pilot lines in compliance with EU regulation on machinery

The “PLATFORM” manufacturing ecosystem for pilot production of pre-commercial CNT-based nano-enabled products, consists of three pilot lines (PPLs) for the manufacture of buckypapers, doped prepregs and doped veils. The PPLs have been constructed with the ultimate goal to commercialize these products in the European market in 2020/2022.This goal requires having the PPLs in compliance with the applicable product safety regulation by that date (CE marking). The main EU regulation for new machinery (as the PPLs) is the Directive 2006/42/EC on Machinery (MD). This Directive sets out the general mandatory Essential Health and Safety Requirements (EHSRs) related to the design and construction of machinery, while particular technical specifications for fulfilling them are provided in European harmonized standards. Application of harmonized standards is voluntary but confers a presumption of conformity with the EHSRs they cover. The PPLs are unique machines for own use and must comply with the MD before they are put into service, in 2020/2022. But the MD does not provide specific EHSRs for nanosafety and no harmonized standards are available in this field for the safe design of the PPLs. In this context, this paper shows the standardization strategy followed by the project PLATFORM (GA 646307) to design the PPLs in compliance with the EHSR referred to the risks to health resulting from hazardous substances emitted by machinery (MD, Annex I, EHSR 1.5.13). In the absence of nanosafety harmonized standards to satisfy the aforementioned EHSR, the design and design verification of the PPLs were carried out through A & B - type harmonized standards (e.g. EN ISO 12100, EN ISO 14123-1/2), and other European and international standards.

Assessment of Microbiological Results of Some Albanian Food Products Compared with Microbiological Criteria

The aim of this study is to assess the microbiological results of some Albanian Food Products like milk, soft and hard cheese, meat, minced meat, eggs also products made by them, compared with microbiological criteria. These food products are most perishable products owing to their biological and chemical composition. A high level of protection of public health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Microbiological hazards in foodstuffs form a major source of food-borne diseases in humans. Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health. Regulation (EC) No 178/2002 lays down general food safety requirements, according to which food must not be placed on the market if it is unsafe (Commission Regulation (EC) No. 2073/2005 of 15 November 2005). Food business operators have an obligation to withdraw unsafe food from the market. In order to contribute to the protection of public health and to prevent differing interpretations, it is appropriate to establish harmonized safety criteria on the acceptability of food, in particular as regards the presence of certain pathogenic micro-organisms. Microbiological criteria also give guidance on the acceptability of foodstuffs and their manufacturing, handling and distribution processes. The use of microbiological criteria should form an integral part of the implementation of HACCP-based procedures and other hygiene control measures. The safety of foodstuffs is mainly ensured by a preventive approach, such as implementation of good hygiene practice and application of procedures based on hazard analysis and critical control point (HACCP) principles (Commission Regulation (EC) No. 2073/2005 of 15 November 2005).

Analysis and Study in Testing of Infrared Therapy Equipment

This article summarizes the common problems in registration and supervision testing of infrared therapy equipment, combines YY 0306-2008 Particular requirements for the safety of heat radiation therapy equipment, GB 9706.1-2007 Medical electrical equipment-Part 1:General requirements for safety, Registration technical review guidelines for infrared treatment equipment, etc. This paper analyzes and discusses the following aspects, including classification and applicable standards, performance indicators and overtemperature protection. Some suggestions and solutions are given to provide some guidance for medical equipment manufacturers in design, research and development and registration, in order to avoid the problem effectively and improve the passing rate of testing.

Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment

Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment

A comparison of private and public sector intensive care unit infrastructure in South Africa.

Intensive care units (ICUs) are designed to care for patients who are often at increased risk of acquiring healthcare-associated infections. The structure of ICUs should be optimally designed to facilitate the care of these critically ill patients, and minimise their risk of infection. National regulations (R158) were developed to govern the building and registration of private hospitals, and until recently equivalent regulations were not available for public hospitals. To assess and compare the compliance of ICUs in the private and public sectors with the R158 regulations. A cross-sectional study design was used to assess the infrastructure of 25 private sector and 6 public sector ICUs in eThekwini Health District, KwaZulu-Natal Province, South Africa. We used the R158 checklist, which was developed by the KwaZulu-Natal Department of Health Private Licensing Unit and Infection Prevention and Control Unit. The aspects covered in the R158 checklist were categorised into the design, general safety and patient services of the ICUs. Most of the ICUs in both sectors met the general safety requirements. There were varying levels of compliance with the design criteria. Only 7 (28.0%) and 1 (16.7%) of the private and public ICUs, respectively, had sufficient space around the beds. Twenty-two private ICUs (88.0%) and 4 public ICUs (66.7%) had isolation rooms, but only some of these isolation rooms (15 private and 2 public) had appropriate mechanical ventilation. None of the ICUs had clinical hand-wash basins in the nurse stations and dirty utility rooms. The majority of the ICUs had the required number of oxygen and electric outlets at the bedside. None of the public ICUs met the light intensity requirement over the bed area. Adequate spacing in ICUs is an issue in many cases. Interventions need to be put in place to ensure that ICUs meet the relevant design standards. There is an urgent need to revise the R158 regulations to reflect current best practices, particularly with regard to infection control. The same standards should be applied to ICUs in the private and public health sectors to maintain quality of care to patients.

Enhanced Regenerative Braking Strategies for Electric Vehicles: Dynamic Performance and Potential Analysis

A regenerative braking system and hydraulic braking system are used in conjunction in the majority of electric vehicles worldwide. We propose a new regenerative braking distribution strategy that is based on multi-input fuzzy control logic while considering the influences of the battery’s state of charge, the brake strength and the motor speed. To verify the braking performance and recovery economy, this strategy was applied to a battery electric vehicle model and compared with two other improved regenerative braking strategies. The performance simulation was performed using standard driving cycles (NEDC, LA92, and JP1015) and a real-world-based urban cycle in China. The tested braking strategies satisfied the general safety requirements of Europe (as specified in ECE-13H), and the emergency braking scenario and economic potential were tested. The simulation results demonstrated the differences in the braking force distribution performance of these three regenerative braking strategies, the feasibility of the braking methods for the proposed driving cycles and the energy economic potential of the three strategies.