Internationally accepted standard

As with all tests, frequent caUbration of the test equipment using standard hardness blocks is a prerequisite for rehable hardness testing (see ASTM E18). Standard hardness blocks are available through commercial sources in the United States but do not have traceabiUty to internationally accepted standards as in Europe. 

A major issue with NGV cylinders has been the lack of a world-wide standard for their manufacture, inspection and testing. Some national standards, such as the New Zealand standard NZS 5454 and the US ANSI/AGA/NGV2 standards have been adopted by other countries. Currently, ISO are working to produce an internationally accepted standard for NGV cylinders. 

All bioassays are comparative in nature, requiring parallel assay of a standard preparation against which the sample will be compared. Internationally accepted standard preparations of most biopharmaceuticals are available from organizations such as the World Health Organization (WHO) or the United States Pharmacopeia. 

In radiocarbon dating, the quantity to be measured is the ratio of the abundances of the rare isotope (14C) to that of the stable isotopes (12C, 13C). These abundance ratios are not measured on an absolute basis, but are compared to that of an internationally-accepted standard. (It is likely that a similar standard will be adopted for 10Be dating.) These measurement requirements have several consequences ... 

In order to ensure that results yielded by a method are as accurate as possible, it is essential to validate the method by analysing standards which have an accepted analyte content, and a matrix similar to that of the sample. The accepted values for these validated standards are obtained by extensive analysis, using a range of different methods. Internationally accepted standards are available. 

Although most assays perform well with regard to specificity and reproducibility, the major problem remains their standardization (A9, Dl, K30, L4). There is currently no internationally accepted standard, and the selection of a reference material raised many problems (A8, G5, K30, L4). A number of questions have not been solved Should the standard consist of several apo(a) isoforms Can the reference material be lyophilized Should results be expressed as mass or as moles of apoprotein or lipoprotein How should the protein mass of the primary standard be determined What are optimal storage conditions for the secondary standard Which method can be used as a reference method Can recombinant apo(a) represent an alternative for a primary standard These problems came to light in the course of the international surveys whose results were presented at the Lp(a) Workshop in New Orleans (1992) (L4). 

This type of counter electrode is defined as a reference electrode. As we will see in Chapter 3, Section 1.2, at 25° C the saturated calomel electrode (SCE) has a potential of +0.2415 V with respect to the standard hydrogen electrode (NHE), which, although difficult to use, is the internationally accepted standard for the potential scale, having conventionally E° — 0.000 V. 

The reliability of the calorimetric results for these reactive organometallic compounds was further substantiated by the observations that the results were all quite reproducible ( 0.1 kcal/mole) and that the results obtained do not depend on (1) the source or method of purification of the base or the solvent (2) the source or method of purification of the alkyllithium and (3) the sodium content of the lithium metal used to prepare the alkyllithiums. Furthermore, the calorimetric equipment was regularly calibrated with internationally accepted standards for calorimetry. 

Pharmaceutical companies wishing to register new products must submit a dossier of data, relating to trials and investigations on the product, to MAFF. When MAFF (VMD) is satisfied that the data are complete and the research has been properly conducted to internationally accepted standards of competence (Good Laboratory Practice - GLP), the dossiers are passed to the VPC. The VPC then assesses the quality, efficacy and safety of the product. The safety assessment on the product includes the target species, human (operator, consumer) and environmental impact. If there are any substantial doubts, the licence may be refused and/or the company advised to carry out further investigations. 

If reference materials are used for calibration or correction of calibration they establish traceability of chemical measurements. Traceability is the link or the vertical comparison between an analytical result and a national or international accepted standard, preferable a realization of the SI unit (see Fig. 7). 

Laboratory accreditation bodies also offer formal recognition (accreditation) of proficiency testing providers to ILAC-G13 2000 (International requirements for competence of providers of proficiency testing schemes). This process is intended to provide confidence that proficiency testing schemes are designed and conducted to internationally acceptable standards. 

In addition to differences described in Chapters 1 and 2 between the proposed system of nomenclature versus the present, internationally-accepted standard IUPAC system, such as ... 

The Evaluation Teaun assesses applications for consent to distribute new and changed medicines and related products and for the approval of clinical trials in New Zealand. The quality, seifety and efficacy of medicines and related products are evaluated according to the provisions of the medicines legislation and internationally accepted standards for pharmaceuticcd registration. 

The papers from the conference were carefully selected from around 100 submissions. The papers were refereed in terms of scientific and technical content and format in accordanee with internationally accepted standards. They were a mix of reviews providing an overview of selected areas, original fundamental research results, and industrial... 

The sponsor/CRO must go through a formal assessment procedure before placement of a study. Some of the most important areas requiring assessment are described in Table 12.2. All studies involving research of investigational medications and devices require qualified investigators, and the internationally accepted standard for qualified usually encompasses three main criteria medically qualified, that is legally licensed to practise medicine as a physician experienced in the relevant therapeutic specialty and experienced in clinical research. 

Measurement of the elemental composition of materials is a relatively mature art. In the natural world there are 92 elements with methods for their quantitative determination generally well established and, in many cases, the subject of internationally accepted standards. However, the physical properties of minerals and materials formed by these elements, and the manner in which they react, is not solely dependant on their chemical composition but on how the constituent elements are arranged that is, their structural form. This finite number of known elements combine into some 230 crystallographic forms with almost infinite variability induced by solid solution, degree of crystallinity, morphology and so on. Therefore, the measurement of the form and amount of the various crystalline and amorphous components is considerably more complex than the measurement of the constituent chemistry. 

The sample accession/logging in process should be secure, that is, there should be no possibility that samples received from outside labs will be left at the wrong temperature for extended periods of time. The sample identity should be unique and trackable. The storage facilities must be qualified and fully documented, that is, temperature probes are monitored continuously and calibrated against internationally accepted standards. 

There is a certain abstractness to chemicals which tends to frighten the layman and allows him to misinterpret the risks potentially associated with chemicals. The consequences of any such misinterpretations can vary in extreme cases from dangerous complacency on the one hand to unnecessary fear on the other. Educating the public in these matters, while extremely difficult, is vital to the future of the chemical industry as a whole. As Andrew Butl, President of Dow Europe said We have too easily become lost in our science and divorced from the outside world while the public was losing confidence in us, we were also losing touch with them [30]. If any such education programme is to be successful, it has to be based on an internationally unified approach to chemical hazards built on internationally accepted standards, criteria and interpretations. 

Isotope laboratories use different reference gases or working standards for the measurement of relative isotope ratios by mass spectrometry. However, all results are reported relative to an internationally accepted standard (Table 10.1). The selection of standards is an important procedure in isotope geochemistry because their definition and availability controls the extent to which results from different laboratories can be compared. 

Quality Assurance/Quality Control Reliable analytical techniques for the determination of total PGM concentrations as well as of PGM-species will become of significant importance in future. Harmonization of analytical results is particularly important in areas concerned with international trade and where it is necessary to assure mutual product recognition. In trade, health, safety, and environmental protection, the clients of analytical laboratories are increasingly in need of proof of reliability and creditability of the results Once measured, everywhere accepted . Therefore, internationally accepted standards need to... 

This scrutiny requires continued diligence and commitment to safety. In the fields of both nuclear safety and security, we are working together to meet or exceed the highest prescribed internationally accepted standards in these fields. Moreover, we must rely on an independent, strong regulatory system to ensure that these standards are maintained. The same can and should be said for all aspects of... 

A Nuclear Safety Division had been set up at the inception of the Agency. In its early years this mainly considered matters of a self-evidently international nature such as the transport of radioactive materials across international boundaries. In the early 1970s the IAEA began developing a Nuclear Safety Standards Programme to create internationally accepted standards on subjects such as siting, design, operation and quality assurance. 

Isotope ratios in a sample are measured and expressed relative to internationally accepted standard samples of accurately known isotope ratios. For example, PDB (Pee Dee Belemnite CaCOs) is used as a standard for carbon its ratio is 0.0112372 [29]. Similarly, Vienna SMOW (Standard Mean Ocean Water) is the standard for oxygen and hydrogen, and air is the standard for nitrogen. Following are the commonly accepted definitions for reporting isotope ratios ... 

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