International Safety Standards Research Articles

Specific Absorption Rate and Current Densities in the Human Eye and Head Induced by the Telemetry Link of an Epiretinal Prosthesis

The fields induced in the human head by the wireless telemetry used for Second Sight Medical Product, Inc.'s epiretinal prosthesis system are characterized for compliance testing with international safety standards using a three-dimensional (3-D) finite-difference time-domain (FDTD) code in D-H formulation. The specific system under consideration utilizes an inductive link with a primary coil mounted on the subject's eyeglasses and a secondary coil that is strapped on the eye, over the sclera. The specific absorption rate (SAR) and the current density have been obtained computationally for different relative positions of the primary and secondary coils to account for the relative misalignment of the two due to the movement of the eye with the implant. For a peak normalized current of 0.62 A in the primary coil at 10 MHz, the highest peak 1-g SAR was found to be 0.45 W/Kg, and the maximum root mean square (rms) current density averaged over a 1-cm2 area was found to be 16.05 A/m2, both of which are within the limits imposed by IEEE and ICNIRP safety standards. Simulations between 2 and 20 MHz indicated that the induced electric field values scale well with frequency, thus providing guidelines for the determination of the final frequency and input power requirements of operation for the telemetry system to meet safety standards.

The opportunities and challenges of civil aviation in India, Part 2: Communications, navigation and surveillance in air traffic management

Civil aviation in India has developed rapidly in recent years. By expanding in line with economic development and tapping into latent demand, it has attained an average annual growth rate of 20 per cent. This rapid rate of expansion has only been possible due to its relatively modest starting point, however, and further growth will require massive investment in infrastructure, redesigning airspace and improving the overall air traffic management system, together with changes in procedures, while maintaining strict adherence to the international standards of safety and security. This paper reviews the country's civil aviation with a special emphasis on the present status of its communications, navigation and surveillance systems. Furthermore, it examines the country's human resources and institutional framework to provide some insights into the challenges that the country may face in the near term. The research underlying the paper was completed while the author was at the MITRE Corporation's Center for Advanced Aviation System Development.

A new modeling approach to the safety evaluation of N-modular redundant computer systems in presence of imperfect maintenance

A large number of safety-critical control systems are based on N-modular redundant architectures, using majority voters on the outputs of independent computation units. In order to assess the compliance of these architectures with international safety standards, the frequency of hazardous failures must be analyzed by developing and solving proper formal models. Furthermore, the impact of maintenance faults has to be considered, since imperfect maintenance may degrade the safety integrity level of the system. In this paper, we present both a failure model for voting architectures based on Bayesian networks and a maintenance model based on continuous time Markov chains, and we propose to combine them according to a compositional multiformalism modeling approach in order to analyze the impact of imperfect maintenance on the system safety. We also show how the proposed approach promotes the reuse and the interchange of models as well the interchange of solving tools.

Safety regulation for the design approval of special form radioactive sources

Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a regulatory expert body, Korea Institute of Nuclear Safety (KINS) assesses various types of application documents, such as safety analysis report, quality assurance program, and other documents evidencing fulfillment of requirements for design approval of the special form radioactive sources, submitted by a legal person who intends to produce special form radioactive sources and then reports the assessment result to MEST. A design approval certificate is issued to the applicant by MEST on the basis of a technical evaluation report presented by KINS.

International safety standards and supporting projects related to demonstrating the safety of radioactive waste disposal facilities

The paper elaborates on the international safety standards related to demonstrating the safety of radioactive waste disposal and provides on overview of the intercomparaison and harmonization projects presently underway.

In Search of a Balanced Relationship: Public and Private Food Safety Standards and International Law

The purpose of this paper is thus to analyze how the interconnection between international food safety standards and the rules of free trade is playing out and what the end-result of such interplay is for the potentially conflicting objectives of free trade and food safety. In performing this analysis, the paper opposes the merits of two types of food safety standards, public and private standards, in order to determine which of them is more likely to constitute an appropriate regulatory model for transnational food safety in the context of the WTO-led liberalization of the international trade in food products. The paper opposes two concrete examples of such standards, namely the public Codex Alimentarius standards, which have been assigned a formal role by the WTO; and the private GLOBALG.A.P. Standard for agricultural products, which is developed in isolation from international trade rules.

The opportunities and challenges of civil aviation in India, Part 1: Airport sector liberalisation

India's civil aviation has been experiencing rapid growth in recent years. This remarkable growth, however, is slowing down this year as aviation worldwide faces volatile and increasingly expensive fuel prices. In conjunction with economic development and tapping into latent demand, the country's civil aviation has been growing at an average rate of 20 per cent during the past few years. While the low base has allowed this rapid expansion, further growth will require massive investments in infrastructure, redesigning airspace and improving the overall air traffic management system, together with changes in procedures while maintaining strict adherence to the international standards of safety and security. This paper reviews the country's civil aviation with a special emphasis on airports. In particular, trends in air traffic together with the present status of the infrastructure provide clear insights into the challenges that the country may face in the near term in dealing with airport development.

Globalization, Competition, and Convergence: Shipping and the Race to the Middle

This article examines the impact of globalization on international environmental, safety, and labor standards through the lens of impact of open registration in shipping--the ability of shipowners to choose in which states to register their ships. Shipowners have moved registration of ships to low-standard states, while traditional national registries relaxed standards in an effort to keep ship registrations. But recent successes in increasing standards have come from mechanisms of exclusion: ships that remain outside the international regulatory process are prevented from benefiting from their free riding by the imposition of trade restrictions, dockworker boycotts, and inspection and detention processes that single out those operating outside the international regulatory framework. KEYWORDS: globalization, environmental standards, labor standards, international regulation, ships. Those concerned about globalization generally have long been concerned that international competition will lead to a downward convergence of environmental and labor standards. This convergence could happen individually--states could competitively lower standards in an effort to lure industry and thus gain economic advantage, in what is referred to as a regulatory race to the bottom, or it could happen collectively, as international standards mandate a least-common-denominator level of regulation. (1) Ingo Walter, despite noting the contribution of environmental costs to plant closings in the United States, suggests that the bulk of the evidence not suggest massive environment-induced locational shifting thus far. (2) Yet evidence, both anecdotal and statistical, suggests that industries sometimes will move to take advantage of low environmental or labor regulations. Walter, despite the broad conclusion of minimal shifting, does point to smelters, refineries, and asbestos plants that were constructed outside the United States due to weaker environmental controls elsewhere. An examination of level of environmental regulation and industry location choices in states belonging to the Organization for Economic and Community Development (OECD) finds a relationship between environmental regulations and level and patterns of exports. As David Wheeler points out, even those who do not find support for the pollution haven hypothesis should exercise caution, because is no theoretical reason why industries with exceptionally high pollution control costs should ignore regulatory concerns. (3) And there is no theoretical reason for governments to ignore such industry decisions in deciding on levels of regulation. The jury appears to be out on the extent to which regulatory havens will come to exist and to draw industry to them and on the broader impact this phenomenon will have on global regulatory levels. Shipping is a particularly relevant sector within which to examine hypotheses about the effects of globalization. This industry demonstrates the very real threat of lowered standards in response to globalization and freer trade. If regulatory havens or races to the bottom are to be encountered any-where, they would likely be found in shipping. As a report from the Australian parliament noted, It is a world of too many ships that are over aged and under maintained chasing too little freight for too little return. (4) Ship registration is an often overlooked method of moving industries to a location with lower environmental and labor standards. Moreover, open registries present a potentially easier form of encouraging industrial movement than do standard pollution havens. From the perspective of shipowners, registration in an open registry does not require physically relocating an industry; it simply means changing the flag flown and the port indicated on the stern. Fees are sent to an office, and inspectors--if any are required--generally go to where the ship is. Many ships registered in such localities never even visit their flag states. …

Exposures from environmental radioactivity: International safety standards

The paper presents the current international system for the protection of the public against environmental radioactivity. The protection system applies to all the three human exposure situations, i.e., planned, emergency and existing exposures. Radiation protection is a developing scientific and practical discipline and some of the areas in public radiation protection and protection of the environment that are in need of further elaboration are identified in the paper.

Nitrate and nitrite in Australian leafy vegetables

A market survey of Australian leafy vegetables and a winter and spring experiment with Swiss chard were conducted to examine nitrate and nitrite levels in leaves. The relationship between growth response to nitrogen (N) supply and light level and accumulation of N in leaves was of particular interest. The survey that included 7 types of lettuce and endive (Asteraceae), 6 leafy Asian vegetables (Brassicaceae), and Swiss chard and spinach (Amaranthaceae) showed that fresh leafy vegetables available during a 6-month period on the Australian market can range in nitrate-N from 12 to 1400 mg/kg fresh weight and nitrite-N from 0 to 37.5 mg/kg. Some samples exceeded the limits for nitrate and nitrite based on international food safety standards. The response of Swiss chard to N supply and light was investigated. The accumulation of nitrate in Swiss chard was primarily influenced by increasing N supply and not by light level. Light conditions for all treatments in both the winter and spring experiments exceeded the critical level (~200 μmol/m2.s) required to increase leaf nitrate. Growth and leaf nitrate concentration were higher for spring, associated with average minimum to maximum temperatures of 18–39°C, compared with 14–28°C for winter. Treatment effects on nitrite-N in Swiss chard could not be determined because nitrite was only detected in one-third of plants. The importance of N supply in affecting nitrate accumulation in vegetables is highlighted by the Swiss chard experiments. It confirmed that nitrate accumulation occurs at optimal to supra-optimal nitrate supply, emphasising for growers the undesirable effect of excessive fertiliser use.

ASSESSMENT OF HUMAN HEAD EXPOSURE TO WIRELESS COMMUNICATION DEVICES: COMBINED ELECTROMAGNETIC AND THERMAL STUDIES FOR DIVERSE FREQUENCY BANDS

In this paper, an integrated and manifold study of the combined electromagnetic and thermal effects, caused by human exposure to microwave radiation is carried out. In essence, we numerically calculate the amount of electromagnetic power absorbed by biological tissues for various exposure conditions and types of emitting sources, utilizing a detailed model of the human head. The severity of the obtained results is evaluated via comparisons with the guidelines of international safety standards, while further insight is gained by investigating the induced thermal effects. The latter are properly quantified through the solution of the bioheat equation, when combined with the outcome of the electromagnetic simulations. Spatial distributions of the corresponding temperature changes are thus calculated, their relation to the dissipated power is established, and the thermal response of human tissues in marginal cases of exposure is predicted.

The dielectric properties of human pineal gland tissue and RF absorption due to wireless communication devices in the frequency range 400–1850 MHz

In order to enable a detailed analysis of radio frequency (RF) absorption in the human pineal gland, the dielectric properties of a sample of 20 freshly removed pineal glands were measured less than 20 h after death. Furthermore, a corresponding high resolution numerical model of the brain region surrounding the pineal gland was developed, based on a real human tissue sample. After inserting this model into a commercially available numerical head model, FDTD-based computations for exposure scenarios with generic models of handheld devices operated close to the head in the frequency range 400–1850 MHz were carried out. For typical output power values of real handheld mobile communication devices, the obtained results showed only very small amounts of absorbed RF power in the pineal gland when compared to SAR limits according to international safety standards. The highest absorption was found for the 400 MHz irradiation. In this case the RF power absorbed inside the pineal gland (organ mass 96 mg) was as low as 11 µW, when considering a device of 500 mW output power operated close to the ear. For typical mobile phone frequencies (900 MHz and 1850 MHz) and output power values (250 mW and 125 mW) the corresponding values of absorbed RF power in the pineal gland were found to be lower by a factor of 4.2 and 36, respectively. These results indicate that temperature-related biologically relevant effects on the pineal gland induced by the RF emissions of typical handheld mobile communication devices are unlikely.

Automatic creation of Markov models for reliability assessment of safety instrumented systems

After the release of new international functional safety standards like IEC 61508, people care more for the safety and availability of safety instrumented systems. Markov analysis is a powerful and flexible technique to assess the reliability measurements of safety instrumented systems, but it is fallible and time-consuming to create Markov models manually. This paper presents a new technique to automatically create Markov models for reliability assessment of safety instrumented systems. Many safety related factors, such as failure modes, self-diagnostic, restorations, common cause and voting, are included in Markov models. A framework is generated first based on voting, failure modes and self-diagnostic. Then, repairs and common-cause failures are incorporated into the framework to build a complete Markov model. Eventual simplification of Markov models can be done by state merging. Examples given in this paper show how explosively the size of Markov model increases as the system becomes a little more complicated as well as the advancement of automatic creation of Markov models.

516 国際安全規格に基づいた空気圧シリンダの信頼性試験精度の向上(OS9-3 ロボティクス・メカトロニクスの技術(3),オーガナイズドセッション:9 ロボティクス・メカトロニクスの技術)

516 国際安全規格に基づいた空気圧シリンダの信頼性試験精度の向上(OS9-3 ロボティクス・メカトロニクスの技術(3),オーガナイズドセッション:9 ロボティクス・メカトロニクスの技術)

Boosting Trade Finance in Developing Countries: What Link with the WTO?

The paper discusses the efforts deployed by various players, mainly multilateral financial institutions, regional development banks, export credit agencies, to mobilize greater flows of trade finance for developing countries, with a view to help them integrate in world trade. As an institution geared towards the balanced expansion of world trade, the WTO is in the business of making trade possible. Its various functions include reducing trade barriers, negotiating and implementing global trade rules, and settling disputes on the basis of the rule of law. The WTO is also interested in strengthening the supply-side of developing countries so that they can respond to new market opportunities. To this end, it supports various initiatives aimed at improving the trade infrastructures of developing countries, ranging from the ability to meet international product, safety and sanitary standards, to run efficient customs, or to participate effectively to the multilateral trade negotiations by training public servants. The WTO carries out various initiatives with other partners (public and private sector institutions), in the context of its own technical assistance program, or in the context of multi-agency projects such as the Integrated Framework or the Aid-for-Trade Initiative. Since more than 90% of trade transactions involve some form of credit, insurance or guarantee, one can reasonably say that trade finance is the lifeline of trade. Producers and traders in developing or least-developed countries need to have access to affordable flows of trade financing and insurance to be able to import and export, and hence integrate in world trade. From that perspective, an efficient financial system is one indispensable infrastructure to allow trade to happen. In line with the above initiatives, the WTO has been following actively, and at times, directly supporting, initiatives to boost the availability of trade finance in developing and least-developed countries wherever it was needed. Since the WTO is not a financial institution, it has been supporting in the past few years partners engaged in this effort such as international financial institutions, export credit agencies, large banks and regional development banks. (...) This paper provides background on the difficulties of some countries and traders to access affordable trade credit and finance, on the growing divide between these low income countries and economically advanced countries in handling modern trade finance instruments, and on the joint reflection undertaken by the WTO, most recently under the Aid-for-Trade programme, and previously under the umbrella of the WGTDF and the Coherence Mandate, to help strengthen developing countries' capacities in this area.

Building Safety—An International Perspective

International health and safety standards to protect construction workers are already in effect but are often ignored by management. Conforming to these standards and implementing other measures described by the author could substantially reduce the high incidences of injuries, illnesses, and fatalities arising from work in this industry.

放射性同位元素等による放射線障害の防止に関する法律等に基づく校正用線源等の現状調査について

An amendment concerning the enforcement of the law on the prevention of radiation hazards due to radioisotopes, etc., and the medical service law enforcement regulations were promulgated on June 1, 2005. This amendment concerned international basic safety standards and the sealing of radiation sources. Sealed radiation sources < or =3.7 MBq, which had been excluded from regulation, were newly included as an object of regulation. Investigation of the SPECT system instituted in hospitals indicated that almost all institutions adhere to the new amendment, and the calibration source, the checking source, etc., corresponding to this amendment were maintained appropriately. Any institutions planning to return sealed radioisotopes should refer to this report.

International safety standards for high-performance marine vehicles – the DSC Code, HSC Codes and the WIG Craft Guidelines

International acceptance of high-performance marine vehicles for commercial operations has been facilitated by the International Maritime Organization’s (IMO) development of a series of safety standards for such craft, commencing with the Code of Safety for Dynamically Supported Craft of1977 and continuing to the present day. The author, as the Australian delegate, has led many of the IMO working and correspondence groups that have carried out much of this work, and been closely associated with the remainder. This paper provides an overview of this series of standards, including notable features of their development. It covers up to and including the 2006 amendments to the 2000 High-Speed Craft Code for relatively conventional high-speed vessels, and the WIG Craft Interim Guidelines and the associated principles and recommendations for operating personnel of such high-speed craft of the future.

Hazards Associated with the Consumption of Sea Turtle Meat and Eggs: A Review for Health Care Workers and the General Public

Sea turtle products (e.g., meat, adipose tissue, organs, blood, eggs) are common food items for many communities worldwide, despite national regulations in some countries prohibiting such consumption. However, there may be hazards associated with this consumption due to the presence of bacteria, parasites, biotoxins, and environmental contaminants. Reported health effects of consuming sea turtles infected with zoonotic pathogens include diarrhea, vomiting, and extreme dehydration, which occasionally have resulted in hospitalization and death. Levels of heavy metals and organochlorine compounds measured in sea turtle edible tissues exceed international food safety standards and could result in toxic effects including neurotoxicity, kidney disease, liver cancer, and developmental effects in fetuses and children. The health data presented in this review provide information to health care providers and the public concerning the potential hazards associated with sea turtle consumption. Based on past mortality statistics from turtle poisonings, nursing mothers and children should be particularly discouraged from consuming all sea turtle products. We recommend that individuals choose seafood items lower in the food chain that may have a lower contaminant load. Dissemination of this information via a public health campaign may simultaneously improve public health and enhance sea turtle conservation by reducing human consumption of these threatened and endangered species.

Design of a neutrino source based on 37Ar isotope and technology of its production

A design of an artificial neutrino source with an activity of 400 kCi and a technology for filling it with 37Ar are described. The compliance of this source to Russian and international safety standards is confirmed by the test results.