International standardization of ancillary medical devices


Product testing is one of the stages for the formation of a complete production cycle in which the final product or service will be presented in the highest quality manner. The same thing happens in the field of medicine, because when creating certain drugs or equipment, as well as services, it is necessary to carry out research stages. Since this industry is directly responsible for human health, the issue of testing, as well as the safety of molecular research testing, is regulated very seriously at many levels. One of these levels is international standardization. If your organization is in contact with medical research and the introduction of medical equipment or molecular research, we strongly recommend that you pay attention to the list of international standards below.

Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1: 2021)

EN ISO 11199-1: 2021

Limb injury is a paralyzing aspect for a certain period of time. The medical sector addressing this problem is complex and includes a large number of medical categories. Osteopathy and physiotherapists are required to undergo continuous professional development in accordance with updated regulatory requirements. One of the most significant examples of such a framework is international standardization. These documents make it possible to reduce the time of empirical research and the formation of results, thereby increasing the productivity and speed of rehabilitation processes in practice. One of the most relevant documents in the field of rehabilitation today is EN ISO 11199-1: 2021.

Dentistry - Tissue punches (ISO 23445: 2021)

EN ISO 23445: 2021

The study of test methods and the derivation of the correct methodological basis for further interaction with this or that equipment is today one of the most realistic options for the development of an organization with a minimum of risks and maximum productivity. When it comes to such a field of human activity as dentistry, the recommendation is the EN ISO 23445: 2021 standard.

This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labeling.

It should be noted that despite the profiling and narrow focus of this document, it implies the possibility of application in the same category, but with the regulation of different stages of activity.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118: 2021)

EN ISO 23118: 2021

Molecular research in the field of urology makes it possible to significantly develop the process of researching the origins of diseases in this category, thereby increasing the rate of cure of a particular ailment. In order for these processes to occur as quickly as possible, such international standards as EN ISO 23118: 2021 are being created.

This document covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. The document is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

When it comes to acquiring 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 amendments that can significantly affect the construction of the entire structure and, if applied incorrectly, increase the number of risks.

Basic semen examination - Specification and test methods (ISO 23162: 2021)

EN ISO 23162: 2021

It is necessary to clearly understand how a certain drug or equipment will affect human health in the course of treatment. That is why a huge amount of time and financial resources are invested in this research. Since this industry is actively developing every day, therefore, the number of regulatory documents regulating it is developing, one of which is EN ISO 23162: 2021.

This document will describe pre-examination, examination and post-examination processes for medical laboratory examination of human semen. It is intended to be used for diagnostics in small and large medical laboratories performing semen analysis. Preparation of semen for therapeutic use is not included.

The recommendations written in this document will significantly help facilitate the introduction of new technologies, and adherence to these standards will significantly increase the speed of innovation in your organization and, consequently, the speed of development of financial results.

International standardization as a complex of innovative solutions

The methodology of carrying out medical activities significantly influences the construction of all subsequent processes. When carrying out laboratory research, norms and requirements are prescribed up to the dimensional grid of the containers used. Since the field of medicine is the industry in which the level of responsibility is increased, international standards can significantly facilitate the process of creating a particular product and focus on achieving the desired financial results with full confidence that the technological base fully complies with the requirements of standardization institutions as well as the laws of that the territory where you are.