International standardization of medical research


International standardization is the engine of progress for both small and medium-sized businesses and entire corporations. Today the world is globalizing and the pace of interaction and business expansion is becoming more and more rapid. In order to constantly remain at the top of the so-called competition pyramid, it is necessary, first of all, to focus on the quality of the services provided and the goods produced. The same applies to the medical industry. But it should also be noted that one of the main criteria is the issue of safety and innovation awareness. When it comes to awareness, it should be noted that it is not only the latest equipment that is important, but also the international standardization that matches its implementation and use. Today we will introduce you to international documents that regulate the use of parts for medical equipment.

Dentistry - Excavators (ISO 23940: 2021)

EN ISO 23940: 2021

The field of dentistry includes the use of a large number of various equipment, which is why it should be clearly understood that the implementation of every detail as well as every type of technology used in this branch of medicine requires clear regulation in accordance with the requirements of legal organizations. Today, one of the most global documents in absolutely any sector, including dentistry, is international standards. When it comes to a certain type of equipment, its implementation, narrow-profile standards that specialize in certain categories and subcategories come to the rescue. One of the prime examples in dentistry is EN ISO 23940: 2021.

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12: 2021)

EN ISO 10993-12: 2021

Despite the fact that, in the main, the application of international standards is carried out both through separate independent documents, sometimes there is no sense in acquiring all the recommendations if the activities of an organization or business come into contact with a small variation of equipment or specialization. That is why each international standard has separate parts that regulate both individual activities and separate recommendations for the implementation of one or another equipment. When it comes to a specific device, it should be noted that even in one international standard, a different number and types of equipment can be considered. One example of such parts of an independent document is EN ISO 10993-12: 2021.

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160: 2020)

EN ISO 14160: 2021

In the light of recent world events, with the development of coronavirus, the regulatory and legal framework of medical equipment, as well as technologies associated with it, has strengthened. It should be noted that the number of diseases of the cardiovascular system has increased, and as a result, the number of documents regulating this industry has increased, one of which is EN ISO 14160: 2021.

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

This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).

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

The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4 ). This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).

This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6). Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.

NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.

NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.

NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.

NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. The following the manufacturing process, a medical device is exposed to a specified sterilization process.

NOTE 5 Such testing is a crucial part of the design and development of a medical device.

NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.

NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

This international standard has a large number of messages to other international documents related to this industry, as well as a certain number of clarifications. Since this industry is responsible for human health, before acquiring a certain standard, it is necessary to consult with a professional in the field of selection of international standardization in order to protect yourself from possible risks.

Dentistry - Denture adhesives (ISO 10873: 2021)

EN ISO 10873: 2021

Dentistry is developing every day more and more actively and this is exactly the field of medical activity that includes one of the largest number of innovative equipment. Technologies do not stand still and are actively being introduced into every sector of medical activity. For each type of equipment, a certain technological base is required, which will give the specialist an understanding of how to work with it and carry out activities in the future. When it comes to regulating the development of medicine in different countries without a significant gap, it becomes necessary to create a unified regulatory system. Today, this is international standardization. One of the most relevant and latest international standards for the field of dentistry today is EN ISO 10873: 2021.

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7: 2021)

EN ISO 80369-7: 2021

Despite the fact that international standardization for the medical sector is mainly associated with the settlement of safety issues, it should be understood that the documentation created directly for the implementation of equipment may include certain parts that are aimed at individual details or at the methodology of its use. One of the striking examples of such documents is EN ISO 80369-7: 2021.

Recommendations for the implementation of international standardization

As you can see, the implementation of each type of equipment as well as individual parts entails a high level of responsibility, which requires a certain compliance with the requirements, norms of a particular territory in which your organization operates. If your business is large-scale on a global level, the availability of international standards is not a recommendation, but a necessary requirement, without which not only development, but also the implementation of activities today will be impossible. We also recommend that you always follow the updates of the documents, so that the activities that your business carries out comply with the norms of the sector in which you operate today.