International standardization of medical auxiliary devices


Product testing is one of the phases for the formation of a complete production cycle in which the end product or service is presented with the highest quality, the same happens in the field of medicine, because when creating certain drugs or devices, as well as services, it is necessary to conduct research phases as this industry is directly responsible for human health, the subject of tests as well as the safety of molecular research tests, it is very strictly regulated. on many levels. One of these levels is international standardization. If your organization is in contact with medical research and medical device adoption or molecular research, we strongly encourage you to refer to the list of international standards below.

Supportive products for walking manipulated with both arms Requirements and test methods Part 1: Frames (ISO 111991: 2021)

EN ISO 111991: 2021

Injuries to the extremities are a debilitating aspect for a certain period of time.The medical sector addressing this problem is complex and encompasses a large number of medical categories; Osteopathy and physiotherapists have to constantly develop professionally in accordance with the current regulatory requirements. One of the most important examples of this framework is international standardization. They make it possible to shorten the time required for empirical research and the generation of results and thus increase the productivity and speed of rehabilitation processes in practice. One of the most relevant documents in the field of rehabilitation today is EN ISO 111991: 2021.

Dentistry tissue punching (ISO 23445: 2021)

EN ISO 23445: 2021

Examination of test methods and deriving the correct methodological basis for a stronger interaction with this or That team today is one of the most realistic options for developing an organization with minimal risk and maximum productivity.For a human field of activity such as dentistry, the recommendation is EN ISO 23445: 2021.

This document specifies the requirements and their test methods for tissue punches that are used with a handpiece in dentistry, in particular for oral surgical implantation procedures. how to make holes or notches and remove gum tissue. It also specifies the requirements for their marking and labeling.


It should be noted that, despite the outlined and narrow focus of this document, the possibility of application in the same category, but with the regulation of different activity phases, is implied.


In vitro molecular diagnostic tests Specifications for pre-test procedures in metabolomics in urine, venous blood serum and plasma (ISO 23118: 2021)

EN ISO 23118: 2021

Molecular research in the field of urology enables significant further development of the Procedure to investigate the causes of diseases of this category and thus to increase the cure rate for a specific disease. To ensure that these processes run as quickly as possible, international standards such as EN ISO 23118: 2021 are created

This document covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for analysis, metabolom.

The document applies to metabolomic examinations and is relevant for biomedical laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and companies involved in biomedical research, biobanks and regulatory authorities. They make it possible to compare and evaluate the results of the analysis of metabolic profiles.

NOTE International, national, or regional regulations or requirements may also apply to specific topics covered in this document.

In obtaining an international standard for the development of the activities of an organization in contact with the medical sector, it is necessary to clearly monitor the presence of certain changes that can significantly affect the construction of the whole structure, and, if necessary, the number of risks.


Basic semen inspection specification and methods of analysis (ISO 23162: 2021)

EN ISO 23162: 2021


It is necessary to have a clear understanding of how a given drug or equipment will affect human health during treatment. Time and financial resources invested in this research.As this industry is actively evolving every day, therefore, the number of regulatory documents that regulate it is evolving, including EN ISO 23162: 2021.

This document describes the pre-testing, testing and reviewing processes of the medical laboratory for human Sperm. It is intended for diagnostics in small and large medical laboratories.


The recommendations contained in this document will greatly facilitate the adoption of new technologies and compliance with these standards will greatly increase the rate of innovation in your company and, consequently, the rate of development of financial results.


International standardization as a complex of innovative solutions


The method used to carry out medical activities has a decisive influence on the construction of all subsequent processes. In laboratory research, standards and requirements are specified down to the dimensional grid of the containers used. Medicine is the industry in which the level of responsibility is increased, international standards can greatly facilitate the process of manufacturing a particular product and focus on achieving the desired financial results, with the full confidence that the technological basis meets the requirements of standardization fully complies with institutions as well as the laws of the territory in which you are located.

0 comments