International standardization of the use of various materials in the field of medicine, biotechnology and manufacturing

Metallic aluminum, ceramic objects surround us everywhere. The popularity of the use of this material covers every area of ​​human activity and is even used in medicine and health issues. Since the production, operation and testing methods of metal products and structures are responsible not only for financial results but also for safety issues, international standards are created to regulate these processes. Since this material is used everywhere, the regulation takes place at the international level. Today we will present a list of some of the newest standards in this area.

Friction stir welding -- Dentistry -- Corrosion test methods for metallic materials

ISO 10271:2020

Test methods for metal products not only prevent possible risks in determining the quality of the final result, but also are responsible for safety issues, especially when it comes to the field of medicine. One of the standards that regulates this industry is ISO 10271: 2020. This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials. This document is not applicable to dental instruments. If you want to get acquainted with more detailed details of this standard, you can go to our website and ask all your questions to the team of experts.

Friction stir welding -- Aluminium

ISO 25239-4:2020

The use of aluminum has grown rapidly since industrialization. As the interaction between countries has become more active over the years, then international standards began to arise for the use of even individual materials. One such document is ISO 25239-4: 2020. This document specifies the requirements for the specification and qualification of welding procedures for the friction stir welding (FSW) of aluminium. In this document, the term "aluminium" refers to aluminium and its alloys. This document does not apply to friction stir spot welding which is covered by the ISO 18785 series. NOTE Service requirements, materials or manufacturing conditions can require more comprehensive testing than is specified in this document. Since this document has a certain number of amendments, we recommend that you clarify in more detail the possibility of its application in your field of activity.

Dentistry --Aluminium

ISO 25239-3:2020

The use of aluminum in the field of medicine, namely dentistry, is in great demand. Since technologies are constantly exchanged between countries, international standards are being created that regulate this industry, one of them is ISO 25239-3: 2020. This document specifies requirements for the qualification of welding operators for friction stir welding (FSW) of aluminium. In this document, the term "aluminium" refers to aluminium and its alloys. This document does not apply to "operators" as defined in ISO 25239‑1. This document does not apply to friction stir spot welding which is covered by the ISO 18785 series. If your field of activity comes into contact with the technologies mentioned above, we recommend that you clarify the detailed aspects of the application of the standard in your company.

Gear hobs -- Colour tabs for intraoral tooth colour determination

ISO 22598:2020

Also, besides metal, one of the most demanded materials is ceramics. Its application in the field of medicine is more and more in demand every day, which is why the importance of such standards as ISO 22598: 2020 should not be underestimated. This document specifies requirements for tooth-like colour representations made of ceramic materials used to determine the tooth colour in the patient's mouth or to check the colour of dental prosthesis, which are referred to as colour tabs in this document. The colour coordinates of colour tabs are left to the manufacturers' discretion. Resources for visualizing the colours of ceramic and other masses, e.g. mass shade guides and colour patterns for certain ceramic and other masses, do not fall into the scope of this document. They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not serve to determine colour inside the mouth. More detailed information on this document can be found at the link to our website. It is there, after reading the characteristics, that you can clarify all your questions.

Gear hobs -- Accuracy requirements

ISO 4468:2020

The technological parameters of production require a very structured and detailed approach, especially when it comes to the specification of the use of various metals and materials. To regulate such processes, standards such as ISO 4468: 2020 are being created. This document specifies requirements for the accuracy of general-purpose hobs of 0,5 module to 40 module. These hobs are intended for producing gears which conform to ISO 53 and ISO 54. This document applies to hobs for spur and helical gears. It applies to solid (monobloc) and inserted blade hobs. The elemental features of hobs are graded according to accuracy, as follows: — Grade 4A; — Grade 3A; — Grade 2A; — Grade A; — Grade B; — Grade C; — Grade D. Grade 4A is the highest order of precision. In addition to the elemental tests for hobs, this document gives permitted tolerances for composite tests that are taken along the cutting edges on the line of action. The two groups of tests are not equivalent and one can choose between one or the other. If there was no previous agreement, the hob is regarded as belonging to the precision class specified if it satisfies one or the other of the two methods of inspection. NOTE The tolerances in this document were determined for gear hobs whose dimensions conform to ISO 2490, but with certain precautions they can be applied to hobs not specified in this document. We recommend that you carefully check all the technical details of this standard before purchasing it for further implementation in the base of your organization.

Biotechnology -- Biobanking -- General requirements for biobanking

ISO 20387:2018

Biological technologies are attracting more and more investments and predict high achievements. But the more technologies emerge, the more standards are created to regulate them, one of which is ISO 20387: 2018. This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development. Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks. This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use. NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document. NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost. If you are operating in the biotechnology industry, you should stay up to date with the latest updates to the international standards market. This will allow you not only to avoid losses, but also to rise to a new level of development in the international market.

A wide variety of areas, united by the standardization of the use of materials

As noted, it is impossible to describe absolutely all areas in which metal is used. But the importance of controlling the quality of the product as well as the process of its use significantly affects the various stages of operations, as well as the final result. As markets merge more and more, risk minimization becomes a significant competitive advantage. If you are thinking about the importance of acquiring a standard specifically for your company, iTeh will help you in choosing the exact document that will become the beginning of the development of product quality that meets international standards and is possible for operation on the global market.

References:

https://www.iteh.ai/catalog/standards/iso/98be93d0-12ea-4b22-9e5f-92b84610729c/iso-10271-2020

https://www.iteh.ai/catalog/standards/iso/cdb07390-f715-408b-b6da-ceec1af3cbef/iso-25239-4-2020

https://www.iteh.ai/catalog/standards/iso/4bce5f1d-d8d1-4463-a3e6-66fb5a44d60b/iso-25239-3-2020

https://www.iteh.ai/catalog/standards/iso/e2f44f32-a6aa-4988-b444-5fc80dbeff1c/iso-22598-2020

https://www.iteh.ai/catalog/standards/iso/308cad67-c8ce-47fb-87d5-3cc3600cd6f2/iso-20387-2018