Updated: Feb 24
Human health is precisely the very aspect that cannot be predicted and it is impossible to give an accurate assessment of the development of events. As the last year has shown, the field of medicine has a huge impact not only on the framework in which it functions, but also on the functioning of any other world system, both economic and financial. Due to the fact that every day today more and more industries and businesses appear in this industry, then the number of regulatory documents regulating this activity is also increasing. Below we will provide you with a list of the most relevant international standards for the use and manufacture of medical devices today. We hope that this information will be the beginning of a new stage in the development of your organization.
For the implementation of certain innovations, as well as their introduction into the system, accompanying international standards are always created that regulate the use of new technologies. Sometimes, in order for the regulatory and legal activities to be carried out most harmoniously, the entire standard changes, but in certain cases, it is enough to create a document, which is a kind of addition, and instead of transforming the entire existing system, it makes only certain additions that do not change the system, but rather increases its productivity . One of such documents is EN ISO 15841: 2014 / A1: 2020.
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442–1:2020)
Risk management is primarily associated by hearsay with business activities, however, minimizing risks can be attributed as a key aspect of the activity of absolutely any industry. One of the international documents regulating this aspect in the field of medicine is EN ISO 22442–1: 2020.
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
Since this document has a large number of amendments, clarifications, and references to other documents, we recommend that you consult with professionals in the field of selection of international standards before purchasing and implementing the system of your organization.
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442–2:2020)
A clarifying addition, or rather a more extended part to the previous document related to risk management in the field of medicine and medical devices, is such a document as EN ISO 22442–2: 2020.
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
Despite the fact that even the number and quality of amendments that are in the two main documents are similar, we recommend that you still study their regulatory areas in more detail in order to avoid mistakes when selecting a document for the development of your business.
Biological evalu ation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993–1:2018, including corrected version 2018–11)
Test methods are one of the main stages of high-quality risk management and building a security system in the implementation of medical activities, which is why the presence of such international standards is very important. One of them is EN ISO 10993–1: 2020.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
Since the field of medicine is a significantly complex concept and an industry covers a large number of subcategories of interacting technologies, we recommend that you have a certain number of basic international standards for the development and construction of a strong scientific technological base that minimizes the main possible risks.
Availability of international standards as a key aspect of the company’s development
Since medical equipment, like any other device, has a large number of technical parameters that must be agreed upon before being introduced into permanent use, therefore, each stage of installing and setting up certain devices requires appropriate instructions and documents. In order for this process to proceed in the most harmonious manner and to minimize by almost 100% possible financial and physical risks, it is necessary to have such documents that will clearly structure the entire process. If your organization is faced with the problem of emerging risks or, in principle, comes into contact with the above technologies, we strongly recommend that you have in place the standards that govern your activities.