scholarly journals Compilation of International Standards and Regulatory Guidance Documents for Evaluation of Biomaterials, Medical Devices, and 3-D Printed and Regenerative Medicine Products

2018 ◽  
Vol 47 (3) ◽  
pp. 344-357 ◽  
Author(s):  
JoAnn C. L. Schuh ◽  
Kathleen A. Funk
Keyword(s):  
Regenerative Medicine ◽  
Medical Device ◽  
International Standards ◽  
International Organization ◽  
Medical Products ◽  
Regulatory Guidance ◽  
Good Laboratory ◽  
Standards And Guidelines ◽  
Guidance Documents ◽  
Country Specific

The development of biomaterials, medical device components, finished medical products, and 3-D printed and regenerative medicine products is governed by a variety of international and country-specific standards and guidelines. Of greatest importance to planning, executing, and reporting biocompatibility, safety and efficacy studies for most biomaterials and medical components or products are the International Organization for Standardization guidelines, U.S. Pharmacopeial Convention, ASTM International, and Conformité Européenne (European Conformity) marking. The International Medical Device Regulators Forum publishes harmonized standards similar to the International Council for Harmonization. Good Laboratory Practices are applicable and guidance documents for the development of drugs and biologics can also be relevant to biomaterials, medical device components, and medical products and more recently to products produced by 3-D printing or additive manufacturing. Regenerative products may have medical device–based scaffolding and may be treated as biologics, reflecting the cell and tissue components. This compilation of international standards and guidelines provides toxicologic pathologists, toxicologists, bioengineers, and allied professionals with an overview of and source for important regulatory documents that may apply to the nonclinical development of their products.

scholarly journals Regenerative medicine: the emergence of an industry

2010 ◽  
Vol 7 (suppl_6) ◽  
Author(s):  
Robert M. Nerem
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Private Sector ◽  
Medical Device ◽  
Engineering Industry ◽  
Full Time ◽  
Business Units ◽  
The World ◽  
The Future ◽  
Pharmaceutical Industries

Over the last quarter of a century there has been an emergence of a tissue engineering industry, one that has now evolved into the broader area of regenerative medicine. There have been ‘ups and downs’ in this industry; however, it now appears to be on a track that may be described as ‘back to the future’. The latest data indicate that for 2007 the private sector activity in the world for this industry is approaching $2.5 billion, with 167 companies/business units and more than 6000 employee full time equivalents. Although small compared with the medical device and also the pharmaceutical industries, these numbers are not insignificant. Thus, there is the indication that this industry, and the related technology, may still achieve its potential and address the needs of millions of patients worldwide, in particular those with needs that currently are unmet.

scholarly journals Three eco-tool comparison with the example of the environmental performance of domestic solar flat plate hot water systems

2013 ◽  
Vol 9 (2) ◽  
pp. 174-181
Keyword(s):  
Environmental Impact ◽  
Environmental Performance ◽  
Life Cycle Analysis ◽  
Hot Water ◽  
International Standards ◽  
Huge Amount ◽  
Product Lca ◽  
Lca Practitioners ◽  
Standards And Guidelines

Life Cycle Analysis (LCA) is a procedure used as an analytical tool for the evaluation of the environmental impact caused by a material, a manufacturing process or product. For an end product, LCA requires both the identification and quantification of materials and energy used in all stages of the product’s life, together with their environmental impact. It requires therefore a huge amount of data about materials, components, manufacturing processes, energy consumption and the relevant environmental impacts. For this reason, a number of software and databases have been developed, in order to facilitate LCA users. These are the so-called Eco-Tools, used in an effort to minimize the environmental impact of a product from the materials and the energy used for production. In this paper, LCA is conducted for solar thermosyphonic systems, with the aid of three commercially available Eco-Tools, usually used by LCA practitioners, namely: Eco-It, GEMIS and SimaPro, and the results are compared. Although all three tools claim accordance with the international standards and guidelines, differences do exist. A typical solar thermosyphonic system (DSHWS) with a 4 m2 collector area and a capacity of 150 dm3 that covers the hot water needs of a three person family in Thessaloniki is used as case study. The results of the three tools are compared for each component of the solar system as well as for each material used and for the conventional energy substituted by the system.

scholarly journals Clinical Trial Regulations In India : Past, Present and Future

JMS SKIMS ◽  
2017 ◽  
Vol 20 (1) ◽  
pp. 5-17
Author(s):  
Haroon Rashid
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Burden ◽  
International Standards ◽  
New Drugs ◽  
Safety And Efficacy ◽  
Long Time ◽  
Regulatory Bodies ◽  
Guidance Documents ◽  
Human Use

Clinical trials are the only way of establishing the safety and efficacy of any new drug before its introduction in the market for human use. Clinical trials (with safeguards) are necessary for introduction of new drugs for a country like India, considering its disease burden and emergence of new variants of disease.The regulatory bodies need to frame guidelines and regulatory approval processes on a par with international standards. Many of the new laws, guidance documents, notifications and initiatives for regulating pharmaceutical industry were in the charts for quite a long time. Indian regulatory authorities have started looking into speedy implementation and providing support in terms ofnecessary infrastructure and investment. JMS 2017; 20(1):5-17

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

scholarly journals Standardization of the size and shape of virtual human body for apparel products

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Hye Suk Kim ◽  
Hee Eun Choi ◽  
Chang Kyu Park ◽  
Yun Ja Nam
Keyword(s):  
Human Body ◽  
Working Group ◽  
International Standards ◽  
International Organization ◽  
Virtual Human ◽  
Size And Shape ◽  
International Organization For Standardization ◽  
Development And Utilization ◽  
Systematic Development ◽  
Group 2

AbstractInternational virtual human body (VHB) standards from the International Organization for Standardization (ISO) specifically used in virtual garment systems in the apparel field, as suggested in ISO/TC 133/WG 2 (Working group 2), contain fundamental content regarding definitions of terms, attributes of composition, and the expression and alteration of VHBs. As the first attempt in the series of international standards dealing with VHBs, this study has dealt with fundamental content related to VHB size. Additional standardization is required to allow the size and shape of VHB to be reproducible. Therefore, this study suggests academic and industrial requirements from the perspective of standardization to identify and solve issues regarding the reproduction of human bodies in terms of VHB size and shape. This study is meaningful in that it provides an overview of current VHB standardization efforts, related proceedings, and additionally required assignments. The suggested industrial and academic requirements are anticipated to be helpful in the systematic development and utilization of VHB and general standardization work.

scholarly journals International Council for Standardization in Haematology Recommendations for Hemostasis Critical Values, Tests, and Reporting

2019 ◽  
Vol 46 (04) ◽  
pp. 398-409 ◽  
Author(s):  
Robert C. Gosselin ◽  
Dorothy Adcock ◽  
Akbar Dorgalaleh ◽  
Emmanuel J. Favaloro ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Ad Hoc ◽  
Test List ◽  
Published Data ◽  
Guidance Document ◽  
International Council ◽  
Hospital Managers ◽  
Coagulation Tests ◽  
Good Laboratory ◽  
Guidance Documents ◽  
Institutional Stakeholders

AbstractThis guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH), the aim of which is to provide hemostasis-related guidance documents for clinical laboratories. The current ICSH document was developed by an ad hoc committee, comprising an international collection of both clinical and laboratory experts. The purpose of this ICSH document is to provide laboratory guidance for (1) identifying hemostasis (coagulation) tests that have potential patient risk based on analysis, test result, and patient presentations, (2) critical result thresholds, (3) acceptable reporting and documenting mechanisms, and (4) developing laboratory policies. The basis for these recommendations was derived from published data, expert opinion, and good laboratory practice. The committee realizes that regional and local regulations, institutional stakeholders (e.g., physicians, laboratory personnel, hospital managers), and patient types (e.g., adults, pediatric, surgical) will be additional confounders for a given laboratory in generating a critical test list, critical value thresholds, and policy. Nevertheless, we expect this guidance document will be helpful as a framework for local practice.

scholarly journals Interdisciplinarity in Higher Petroleum Education in the Context of International Standards

2017 ◽  
Vol 7 (4) ◽  
pp. 52-57
Author(s):  
Nadiya Tymkiv
Keyword(s):  
Interdisciplinary Approach ◽  
Faculty Members ◽  
International Standards ◽  
Petroleum Engineering ◽  
Young Generation ◽  
Educational Framework ◽  
Standards And Guidelines ◽  
Teaching Paradigm ◽  
Engineering Training ◽  
Specific Learning

Abstract The article deals with the problem of interdisciplinarity impact on higher petroleum education in Ukraine. Different views on the essence of interdisciplinarity, especially in the context of higher petroleum education, have been presented. It has been indicated that many scholars have studied the essence of interdisciplinarity within higher education systems of different countries and identified that interdisciplinarity encompasses a combination or interrelation of various sciences that are embodied in engineering training process. Interdisciplinarity is considered as one of the effective tools to support enthusiasm of young generation for petroleum engineering; to increase motivation of future petroleum experts; and to enhance the efficiency of collaboration between professionals from different fields. In reality, interdisciplinary approach is very often confused with multidisciplinarity when educators give students knowledge from various disciplines without making the link between them into a coordinated whole. It has been concluded that interdisciplinarity or interdisciplinary approach can be regarded as a natural training context in which boundaries between knowledge systems tend to be erased and a new teaching paradigm is required. It has been revealed that implementation of interdisciplinary approach in engineering programmes necessitates the development of such an educational framework that would provide educators with the relevant methods, tools, and models for design of interdisciplinary engineering curricula regarding specific learning outcomes and ensure support for faculty members to improve their own competence in the interdisciplinary issues. The standards and guidelines of international educational interdisciplinarity of degree programmes in petroleum engineering are analyzed in the article.

A regulator's perspective: well integrity considerations in decommissioning

2020 ◽  
Vol 60 (2) ◽  
pp. 633
Author(s):  
Claire Hick ◽  
Derrick O’Keeffe ◽  
Mark Bourne
Keyword(s):  
Lower Cost ◽  
Economic Life ◽  
International Standards ◽  
Well Control ◽  
Monitoring Well ◽  
Well Integrity ◽  
Standards And Guidelines ◽  
Petroleum Fields ◽  
Reduce Risk ◽  
Well Abandonment

With several petroleum fields in offshore Australia approaching the end of their economic life, it is widely recognised that there is an upcoming wave of well decommissioning. Decommissioning of wells (also known as ‘plug and abandonment’ or well abandonment) presents well integrity and, in some instances, well control challenges. Deferral of well abandonment is likely to make the task more difficult; wells are continually ageing and, meanwhile, the benchmark for what constitutes a compliant abandonment tends to get higher over time. It is a common objective of industry, government and society that wells are decommissioned properly so that they do not present future safety or environmental risk. Decommissioning a well safely requires that it has been maintained properly with a reliable dataset and documentation history. A clear framework for managing and monitoring well integrity in all phases of the well lifecycle is a prerequisite, as demonstrated in international standards and guidelines such as ISO 16530. Well decommissioning requires collaboration across industry partners to foster research and development, reduce risk and lower cost.

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