International standardization of medical research


International standardization is the engine of progress for small and medium-sized companies as well as for entire corporations. Today the world is globalizing and the pace of business interaction and expansion is getting faster and faster. At the top of the so-called competition pyramid, it is first necessary to concentrate on the quality of the services provided and the goods produced, just as in the medical industry, but also to note that one of the main criteria is safety and innovation awareness. Regarding awareness, it should be noted that not only is the latest generation of equipment important, but also international standardization that coincides with its implementation and use. Today we are introducing you to international documents that regulate the use of parts for medical devices.


Dental Excavator (ISO 23940: 2021)

EN ISO 23940: 2021


The field of dentistry involves the use of a large number of different devices, so it should be clear that the implementation of every detail is also used since all kinds of technologies are used in this branch of medicine requires clear regulation according to the requirements of legal organizations, today one of the most global documents in absolutely every industry, including dentistry, is an international standard. of devices, the implementation of which, narrow profile standards specializing in certain categories and sub-categories, help. One of the most important examples in dentistry is EN ISO 23940: 2021.

Biological evaluation of medical devices Part 12: Sample preparation and reference materials (ISO 1099312: 2021)

EN ISO 1099312: 2021


Although the application of international standards is generally so heavily carried out through separate independent documents, sometimes it does not make sense to seek all recommendations when the activities of an organization or company with a small variation in equipment or specialization in get in touch.


Biological assessment of medical devices Part 12: Preparation of samples and reference materials (ISO 1099312: 2021)

EN ISO 10993-12: 2021

Although the application of international standards is generally done through separate independent documents, sometimes it does not make sense to all Acquiring recommendations when the activities of an organization or company come into contact with a small variation in equipment or specialization, therefore each international standard has separate parts that regulate both individual activities and separate recommendations for implementation. of one or the other equipment. When dealing with a specific device, it should be noted that an international standard can also take into account a different number and type of equipment. An example of such parts from a separate document is EN ISO 10993-12: 2021.

Sterilization of medical devices Liquid chemical sterilization agents for medical devices for single use using animal tissues and their derivatives Requirements for the characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160: 2020)

EN ISO 14160: 2021

In view of recent world events with the development of the coronavirus, the regulatory and legal framework for medical devices and related technologies has been strengthened, and the cardiovascular system has increased as a result incremented the amount of documents that regulate this industry. increased, one of them is EN ISO 14160: 2021.

This document specifies the requirements for the characterization of a liquid chemical sterilization agent and for the development, validation, process control and monitoring of the sterilization by liquid chemical sterilization agents solid medical devices, in whole or in part consist of materials of animal origin.

This document deals with the control of risks arising from contamination with bacteria and fungi through the use of a liquid chemical sterilization process.The risks associated with other microorganisms is connected, can be analyzed with other methods (see Note 1).

This document is not applicable to the material of human origin. This document does not describe the methods for validation of viral inactivation and transmissible spongiform encephalopathy (see Note 2 and Note 3). This document does not describe the methods for validating the inactivation or elimination of protozoa and parasites.


The routine validation and control requirements described in this document only in the defined sterilization method of a medical device to apply, which is carried out after the manufacturing process, and do not take into account the lethal effects of other reduction steps the bioburden (see Note 4).


This document is not set to produce selected the tests, the effect of a sterilization process in the physical state for the use of the medical device (see Note 5).

This document is not related to the residual medicine sterilizing agent level within (see note 6).

instructions for characterizing a liquid chemical sterilization agent and for the development, validation, process control and sterilization with chemical liquid chemical products in the exclusive medical devices includes monitoring, are fully or partially the material of animal origin in information. Appendix A Note 1 The state of the application of the principles of risk management to medical devices that use animal tissues, as described in ISO 22442-1, is important. No. 18362 contain information on the control of microbial risks in the processing of cellular health care products.

Note 2 The liquid chemical sterilization agent may not use traditional animal tissues to medical devices in the inactivation of TSE agents such as bovine spongiform encephalopathy (BSE) or scrapie, to effectively sterilize. Satisfactory validation of this document in accordance show not necessarily the inactivation of infectious agents of this kind. The risk control related to the supply, harvesting and handling of animal materials in ISO 22442-2.

NOTE 3 Validation of virus inactivation, removal, disposal and TSE inactivation and - exciter in ISO described 22442-3.


Note 4 manufacturing process for medical devices often include animal tissue include exposure to chemical agents which reduce significantly the bioburde in the medical device. The next manufacturing process is a medical device is subjected to a specific sterilization process.

Note 5 Such tests are an important part of the construction and development of a medical device.


Note 6 ISO 1,099,317 discloses a method to establish authorized limits for sterilant residues.


Note 7 The standards for quality management systems (see ISO 13485), the control of all stages of production, be used, including the sterilization process.


This international standard contains a large number of messages on other international documents related to this industry, as well as some clarification. Since this industry is responsible for human health, it is necessary to consult a professional before acquiring any particular standard. in the area of ​​the selection of international standardization in order to protect against possible risks.


Dentistry adhesives for dentures (ISO 10873: 2021)

EN ISO 10873: 2021


Dentistry is developing more actively every day and it is precisely this medical field of activity that includes one of the most numerous innovative devices. they do not stand still and are actively introduced in all areas of medical activity, each type of device requires a certain technological base that allows the specialist to understand how to deal with it and develop future activities. The aim is to regulate the development of medicine in different countries without gaps; it is necessary to create a uniform regulatory system.


Small diameter connectors for liquids and gases in healthcare Part 7: Connectors for intravascular or subcutaneous applications (ISO 803697: 2021)

EN ISO 80369-7: 2021

Although international standardization for the medical sector is mainly related to the definition of safety issues, It is understood that the documentation created directly for the implementation of devices may contain certain parts that relate to individual details or the methodology of their use. A striking example of such documents is EN ISO 80369-7: 2021.

Recommendations for the implementation of the international standardization


As you can see, the implementation of every device type and its individual parts carries a high level of responsibility. that requires specific compliance with the requirements and standards of a specific area in which your organization operates. If your company is on a large scale worldwide, the availability of international standards is not a recommendation, but a necessary prerequisite, without which not only the development, but also the implementation of activities is not possible today. We also recommend that you always follow the updates to the documents so that the activities your company carries out are in line with the standards of the industry in which it operates today.

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