International standards for medical devices

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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.

Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)

{EN ISO 15841:2014/A1:2020](

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. The peculiarity of the certain standard is in combination of electrical systems and medical sector. Get acquainted with more details of it in case your business is implementing new medical technologies.

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

EN 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. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives.

This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:

  • contamination by bacteria, moulds or yeasts;
  • contamination by viruses;
  • contamination by agents causing transmissible spongiform encephalopathies (TSE); material responsible for undesired pyrogenic, immunological or toxicological reactions.

For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not cover the utilization of human tissues in medical devices.

NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.

NOTE 2 For guidance on the application of this document, see Annex A.

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)

EN 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. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.

This document does not cover the utilization of human tissues in medical devices.

This document does not specify a quality management system for the control of all stages of production of medical devices.

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.

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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

EN ISO 10993-1:2020

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.

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).

This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. 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.