International standardization of mechanical contraceptives

At least 12 countries have regulations for condoms, and because of the complicated regulations relating to condoms the International Organization for Standardization (ISO) was asked to create a committee for contraceptives. Its objective is to promote the development of standards throughout the world to help the international exchange of goods and services. Following discussions between the World Health Organization (WHO) and ISO it was decided in 1974 to establish a technical ISO committee that would deal with international standards for mechanical contraceptives, comprising condoms, diaphragms, and IUDs. It was also decided that spermicides and oral contraceptives (OCs) should be excluded from the ISO effort, but that they should fall within the responsibility of WHO. The committee, entitled ISO/TC 157 Mechanical Contraceptives, was represented by 35 member countries in 1982. The object of standardizing condoms is to obtain a satisfactory quality that can be accepted throughout the world. To achieve that purpose, acceptable test methods and associated limit requirements and values must be determined, along with rules for storage, packaging, and labeling. The most important factors in determining condom quality are the need to reach agreement on an acceptable number of holes in the condom and the ability to establish limit values for the mechanical properties of the condom. Specific requirements regarding dimensions, resistance to storage, packaging, labeling, and appropriate storage are also important. Up to 1982 the work of ISO for condoms resulted in 8 published international standards, of which 6 deal with test methods, 1 with packaging and labeling, and 1 with storage. Agreement has also been reached within the ISO committee on an additional 3 draft standards. Due to the comparatively small use of diaphragms, standardization efforts in this area do not have the highest priority. ISO/TC 157 has formulated 10 drafts which are being prepared for distribution to the ISO member countries for purposes of voting. 7 of these standards deal with test methods, 1 with sampling and requirements, 1 makes storage recommendations, and 1 refers to packaging and labeling. A working group for standardizing IUDs was established in 1976. It was agreed within ISO/TC 157 after almost 3 years to publish a Technical Report (TR 7439) for IUDs. The report deals with such things as the definition of IUDs, general requirements for type approval, batch inspection, storage recommendations, and packaging and labeling. The report shall constitute the basis for continued standardization efforts for IUDs.     

International standards on mental work-load--the ISO 10,075 series.

After a short review of the history and an introduction into the background of standardization in the field of mental work-load an overview over the ISO 10,075 series of standards on ergonomic principles related to mental work-load is given. The review also presents relationships of these standards with some other ergonomic standards and some of the problems associated with standardization in the field of mental work-load. The stress-strain model, the concepts and the terminology used in ISO 10,075 are presented in the overview, together with the basic ideas and the frame of reference of the design guidelines provided by ISO 10,075-2. An outline of the state of discussion and possible developments of a working draft for ISO 10,075-3 on diagnostic methods concludes the presentation of the international standards on mental work-load.     

Standardised methods--tools for mutual understanding and integration into global society.

The paper presents basic concepts, terms, and their definitions in the field of standardisation--standard, international standard, national standard, testing standard, test report, and proficiency testing according to the ISO/IEC Guide 2:1996. The paper also explains the role of voluntary standards in the process of technical harmonisation. National adoption and implementation of international testing standards facilitates testing, comparison of test reports, and any proficiency testing, and can promote their global recognition. This can be recognised as a step toward creation of the global society. The Croatian "approach" to these activities is given attention in the light of globalisation and efforts made in establishment of Croatian standardisation infrastructure.     

Accreditation of analytical laboratories and proficiency testing: experiences from Thailand on the issues of pesticide analysis.

Thailand, the economic growth of which largely depends on agriculture-based industry, recognizes the importance of international standards for harmonization of international food trade and for protection of human health from chemicals used as food additives or those present as contaminants. Pesticides which are widely used in Thailand are the anticholinesterase pesticides, pyrethroids, coumarin derivatives, bipyridinium salts, and to some extent organochlorine compounds such as DDT in malaria control. Proficiency testing and accreditation of laboratories are recognized as effective means to ensure quality and validity of data and to enable adequate risk assessment of pesticide residues in food, work environment and environment in general. The paper is a synthesis of relevant local reviews and in-depth interviews with experts in the area of pesticide laboratory accreditation and proficiency testing. The paper refers to other schemes for quality assurance such as ISO guide 25, ISO 9000, and ISO 14000, and addresses future prospects of ongoing activities such as accreditation of inspection bodies in the area of industrial chemicals and occupational safety and health.     

Retinal phototoxicity: a review of standard methodology for evaluating retinal optical radiation hazards

Optical radiation (light) safety standards can be difficult to use for the evaluation of light hazards to the retina, even for persons experienced in radiometry and photometry. This paper reviews terminology and methodology for evaluating optical radiation hazards to the retina in accordance with international standard ISO 15004-2 Ophthalmic instruments-Fundamental requirements and test methods, Part 2: Light hazard protection (2007). All optical radiation safety standards use similar methods. Specifically, this paper illustrates how to evaluate the retinal hazards from various ophthalmic instruments including the following: diffuse illumination of the cornea; incident light diverging at the cornea (direct ophthalmoscope, operation microscope, fixation lamp); and incident light converging at the cornea (indirect ophthalmoscope, fundus camera, slit lamp biomicroscope). A brief review of radiometry and the use of certified optical components by manufacturers as specified by the ISO standard is also provided. Finally, the authors provide examples of the use of photometric measurements in hazard evaluation.     

Adapting veterinary infrastructures to meet the challenges of globalisation and the requirements of the World Trade Organization Agreement on Sanitary and Phytosanitary Measures

To maximise the benefits of globalisation, countries and their stakeholders must become familiar with and adhere to the rights and obligations set out by the World Trade Organization under the Agreement on Sanitary and Phytosanitary Measures. Furthermore, for trade in animals and animal products, they must adhere to the standards, guidelines and recommendations established by the OIE (World organisation for animal health), which also encourages participation of countries in the standard-setting process. Only after implementing these requirements and strengthening veterinary infrastructures and surveillance and monitoring systems, will countries be able to fully benefit from the new international trade rules.     

Quality improvement of medical diagnostic laboratories

Service quality in medical laboratories is influenced by a number of variables. Medical laboratories have long recognized the need for total quality management that incorporates the continuous improvement of all stages, such as the pre-analytical, analytical and post-analytical phases, of the diagnostic process, in addition to the traditional internal and external quality control of analytical procedures. Based on national and international experience, continuous improvement of quality and its external assessment are of high priority in order to guarantee a reliable, effective and cost-effective diagnostic service. Certification of health care services, according to ISO 9001 standards in Hungarian hospitals, is not sufficient to prove professional competence of medical laboratories, which called for a system of laboratory accreditation. Accreditation is an external professional audit by which an independent accreditation body gives formal recognition that the medical laboratory is competent to provide high quality services that are compliant with rigorous professional standards of best practice. The primary aim of accreditation is the improvement of the quality of diagnostic services by voluntary participation, professional peer review, continuous training and education and compliance with professional standards. In vitro medical laboratories have pioneered quality control and quality assurance in health care. Based on these strengths and traditions, the introduction of the accreditation program of medical laboratories in Hungary is one of the key professional and ethical responsibilities of diagnostic professions, in order to improve the quality, efficiency and effectiveness of laboratory services during the course of Hungary's accession to the European Union.     

Testing standards for sporicides

Sporicidal products are of considerable importance in healthcare environments due to the requirement for products that are capable of dealing with contamination with Clostridium difficile spores. Sporicidal testing standards to validate the claims of sporicidal activity are an important tool in the evaluation of commercial sporicides. Within Europe there are a number of sporicidal testing standards which are often used to validate the claims of commercial sporicides. However, the extent to which these standards reflect the practical application of sporicides in healthcare settings is limited since they employ long contact times (≥30min) and do not involve surface contamination. Alternative international standards are available which employ contaminated carriers rather than spore suspensions, and the Organisation for Economic Co-operation and Development is currently developing a unified set of standards which are more realistic in their design than the currently available European standards. This paper reviews the currently available testing standards for sporicides, highlighting the key procedural differences between them and the extent to which they reflect the practical application of sporicidal products. Some of the common problems and errors associated with the application of the European sporicidal standard methods are also highlighted and discussed. Finally gaps in the currently available testing standards are identified and discussed.     

Quality assurance in military medical research and medical radiation accident management

The provision of quality radiation-related medical diagnostic and therapeutic treatments cannot occur without the presence of robust quality assurance and standardization programs. Medical laboratory services are essential in patient treatment and must be able to meet the needs of all patients and the clinical personnel responsible for the medical care of these patients. Clinical personnel involved in patient care must embody the quality assurance process in daily work to ensure program sustainability. In conformance with the German Federal Government's concept for modern departmental research, the international standard ISO 9001, one of the relevant standards of the International Organization for Standardization (ISO), is applied in quality assurance in military medical research. By its holistic approach, this internationally accepted standard provides an excellent basis for establishing a modern quality management system in line with international standards. Furthermore, this standard can serve as a sound basis for the further development of an already established quality management system when additional standards shall apply, as for instance in reference laboratories or medical laboratories. Besides quality assurance, a military medical facility must manage additional risk events in the context of early recognition/detection of health risks of military personnel on deployment in order to be able to take appropriate preventive and protective measures; for instance, with medical radiation accident management. The international standard ISO 31000:2009 can serve as a guideline for establishing risk management. Clear organizational structures and defined work processes are required when individual laboratory units seek accreditation according to specific laboratory standards. Furthermore, international efforts to develop health laboratory standards must be reinforced that support sustainable quality assurance, as in the exchange and comparison of test results within the scope of external quality assurance, but also in the exchange of special diagnosis data among international research networks. In summary, the acknowledged standard for a quality management system to ensure quality assurance is the very generic standard ISO 9001.Health Phys. 103(2):221-225; 2012.     

ISO14155:2011标准简介及其在我国应用前景的展望

医疗器械新产品在上市以前,为了确认产品安全有效,一般应对其进行临床研究。世界各国对如何进行医疗器械临床研究的要求都是非常严格的,如FDA、欧盟和我国的监管部门等都已颁布了医疗器械临床研究的相关法规或指令。ISO14155标准是用于世界范围内医疗器械的临床研究标准,其主要内容是评价医疗器械在人体应用的安全性并确认其使用的有效性。ISO 14155:2011是医疗器械临床研究的临床质量管理规范(GCP),与前版标准相比,新版标准内容更加丰富,要求更高,实用性和可操作性更强。因此,其在我国也将具有良好的应用前景。     

Scientific and legal perspectives on science generated for regulatory activities

This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information.     

Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety,industry/regulator efficiency or both?

The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.     

International standards related to the classification and deregulation of radioactive waste

Although solid radioactive waste management is mainly a national concern, there are some aspects that have international implications. One important example is the decommissioning of nuclear facilities, which results in the release of materials that could be reused and recycled. It is possible that these materials could enter international trade, especially if the material is a metal. It is clearly desirable, therefore, to have appropriate international standards to help regulate trade. This paper describes recent international developments relating to the establishment of radiological criteria for the release of materials from regulatory control (clearance). There have already been some experiences of clearance and the transfer of recycled materials within Europe, and this paper reviews that experience. It also discusses recent developments in relation to the international classification of radioactive waste.     

ISO 9000族标准与医院质量管理

ＩＳＯ９０００族标准体系，作为质量管理、质量保证的国际标准，为医院质量管理提供了重要的标准化形式。通过对ＩＳＯ９０００族概况的介绍，以及各质量保证要素与医院质量管理的关系的分析，意在帮助人们进一步了解ＩＳＯ９０００族标准的内涵，提高对ＩＳＯ９０００在医院质量管理标准化建设方面重要意义的认识 。     

医院质量管理体系诊断与改进中评价标准应用研究

为实现医院质量管理体系的诊断与改进，本文对ISO9000：2000标准和Baldrige标准的结构、主要内容以及两者的特点等进行了分析比较。在此基础上，提出一个将ISO9001和Baldrige标准集成的模型，并应用于医院质量管理体系的诊断与改进过程。该模型依据Baldrige标准，分析诊断出医院质量管理体系中存在的主要问题及改进策略，进而通过两个标准之间的相关关系，将质量管理体系改进策略分解配置到相关的ISO9001条款；最后，参照ISO9001标准中相应条款的要求，制订出具体的改进计划和改进措施。     

Working towards compliance with international standards

Developing countries are increasingly coming under pressure to improve their delivery of veterinary services as a prerequisite for entering the competitive arena of international trade in animals and animal products. The demands placed on developing countries by predominantly developed countries to comply with international disease prevention standards have also resulted in increasing demands on the financial, human and technological resources of these developing countries. The minimum requirements of the Agreement on the Application of Sanitary and Phytosanitary Measures and the standards, guidelines and recommendations of international standard-setting organisations, such as the OIE (World organisation for animal health), are evaluated in terms of the opportunities embedded within these guidelines for developing countries. Such an evaluation indicates that the rights and obligations contained in these standards, guidelines and recommendations do not necessarily protect only the interests of developed countries but also encourage developing countries to work towards the levels of compliance and disease prevention required by their potential trade partners. The costs of this compliance can be reduced by exploiting more cost-effective alternatives for delivering services, when dictated by budgetary constraints. International organisations have illustrated on many occasions, and through a variety of development programmes, that they do indeed realise their responsibility towards developing countries in the areas of increased capacity building and technical assistance. If international organisations can refocus their interventions on the actual and specific needs of developing countries, then they can help to expedite the process of compliance with international standards.     

Harmonisation of food labelling regulations in Southeast Asia: benefits, challenges and implications

In the globalised world of the 21st century, issues of food and nutrition labelling are of pre-eminent importance. Several international bodies, including the World Health Organisation and World Trade Organisation, are encouraging countries to harmonise their food and nutrition regulations with international standards, guidelines and recommendations such as those for Codex Alimentarius. Through harmonisation, these organisations envisage fewer barriers to trade and freer movement of food products between countries, which would open doors to new markets and opportunities for the food industry. In turn, increased food trade would enhance economic development and allow consumers a greater choice of products. Inevitably, however, embracing harmonisation brings along cost implications and challenges that have to be overcome. Moreover, the harmonisation process is complex and sporadic in light of the tasks that countries have to undertake; for example, updating legislation, strengthening administrative capabilities and establishing analytical laboratories. This review discusses the legislation and regulations that govern food and nutrition labelling in Southeast Asia, and highlights the discrepancies that exist in this regard, their origin and consequences. It also gives an account of the current status of harmonising labelling of pre-packaged foodstuffs in the region and explains the subsequent benefits, challenges and implications for governments, the food industry and consumers.     

A Clash of Old and New Scientific Concepts in Toxicity,with Important Implications for Public Health

Background

A core assumption of current toxicologic procedures used to establish health standards for chemical exposures is that testing the safety of chemicals at high doses can be used to predict the effects of low-dose exposures, such as those common in the general population. This assumption is based on the precept that “the dose makes the poison”: higher doses will cause greater effects.

Objectives

We challenge the validity of assuming that high-dose testing can be used to predict low-dose effects for contaminants that behave like hormones. We review data from endocrinology and toxicology that falsify this assumption and summarize current mechanistic understanding of how low doses can lead to effects unpredictable from high-dose experiments.

Discussion

Falsification of this assumption raises profound issues for regulatory toxicology. Many exposure standards are based on this assumption. Rejecting the assumption will require that these standards be reevaluated and that procedures employed to set health standards be changed. The consequences of these changes may be significant for public health because of the range of health conditions now plausibly linked to exposure to endocrine-disrupting contaminants.

Conclusions

We recommend that procedures to establish acceptable exposure levels for endocrine-disrupting compounds incorporate the inability for high-dose tests to predict low-dose results. Setting acceptable levels of exposure must include testing for health consequences at prevalent levels of human exposure, not extrapolations from the effects observed in high-dose experiments. Scientists trained in endocrinology must be engaged systematically in standard setting for endocrine-disrupting compounds.