International standards that apply to the medical materials market


The provision of medical services is a very complex and important process. Professionals who work in this area are responsible for the safety of the health of their patient. Given this moment, it becomes obvious how carefully they select the materials with which they will work in the future. Companies that manufacture medical supplies must be able to properly control the quality of the product they produce. It is worth making an additional emphasis on the fact that most of these materials are in direct contact with the patient's body, so they must be completely safe for the body. The main task of the manufacturer of these products is to make sure that they do not contain any substances that could harm a person. The list of prohibited items can be very large and companies that work in the field of medical products need to know and follow it. Based on the importance of providing customers with safe and good products, new standards are constantly being created that regulate their quality. Today, we have prepared a material for you, in which we considered what requirements are for medical materials in the field of dentistry and ophthalmology, and also included information for you regarding testing systems. These documents will be useful for companies that manufacture products for medical activities.

Dentistry - Hydrocolloid impression materials

EN ISO 21563:2021

Hydrocolloid impression materials have been widely used in dentistry for a very long time. This material is widely demanded among specialists. However, it is worth noting that companies that manufacture it must carefully monitor its quality, as well as safety for patients. The requirements and necessary standards for this medical material are specified in the international standard EN ISO 21563:2021.

This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

A feature of this international standard is that it regulates the quality requirements for produced hydrocolloid impression materials. Knowing this document will help your company produce a guaranteed quality product. If you are interested in this standard and you would like to study it in more detail, then you can familiarize yourself with it on our website, using the link attached below.

Dentistry - Endodontic obturating materials

EN ISO 6877:2021

Specialists who use endodontic obturation materials in their work always, first of all, pay attention to their quality and safety for the human body. Among the wide variety of these materials, it is important to have clear criteria for their quality. International quality requirements for dental endodontic obturation posts are described in EN ISO 6877:2021.

This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points.

Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use.

This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

The above international standard aims to help companies produce high quality endodontic obturation materials that are also safe for patients. We recommend purchasing this standard for anyone working in this field. Given the wide variety of documents that can regulate this industry, our specialists are always ready to help you choose the standards that are right for you.

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

EN ISO 16672:2021

The digitalization of society and the large number of hours of screen time causes vision problems, and many people need surgical intervention in the structure of their eyes. It is quite obvious that all ophthalmic implants must be of the highest quality and absolutely safe. International requirements for them are described in such a standard EN ISO 16672:2021.

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

The international standard, which we wrote about above, is a necessary document for study for companies that manufacture ophthalmic endotamponade. It clearly describes the necessary requirements for the production and further logistics of these products. If you are interested in this information, you can read the full text of this standard on our website.

The safety of medical materials is the foundation of health

If your company is engaged in the production of products intended for medical purposes, then you need to know the standards that help monitor the quality of your product. Knowledge of international standards and their implementation in work allows companies to produce a high-quality and safe product. This is one of the most important postulates on which a company that wants to take a leading position in its market segment must build its strategy. Concern for the safety of the end user of their product is an important component of the work of all companies that are engaged in the medical business. Any surgical intervention in the human body is inherently dangerous. The task of doctors is to ensure the health of their patient. Manufacturers of medical supplies, in turn, must provide specialists with a high-quality and safe product with which they can work. The specialists of our company are always ready to help you if you need additional advice or assistance in choosing international standards that need to be implemented in the work of your company.