Medical standards are not a recommendation, but a necessity

Updated: Feb 24


Over the past year, the issue of medicine and the use of medical equipment has been gaining more and more popularity every day. It should be noted that the increase in the use of devices in the field of medicine implies a directly proportional increase in the number of standards that regulate these processes at the international level. Since in this industry quality is responsible for the preservation of people’s health, it is necessary to pay very important attention to the norms that minimize the risks of negative consequences. Today we will introduce you to the standards for the use of medical equipment, which you must have in place if your areas of activity are even slightly in contact with medicine.


Ophthalmic optics — Co ntact lenses and contact lens care products — Labelling — Amendment 1 (ISO 11978:2017/Amd 1:2020)

ISO 11978:2017/A1:2020


Like any standard, an international document regulating the use of international rules for medical equipment has a certain number of clarifications and additions. One example is ISO 11978: 2017. Since the aforementioned standard needs to be changed over time, such additions as EN ISO 11978: 2017 / A1: 2020 are created. If you are in contact with activities that require this document, we recommend that you familiarize yourself in more detail with all its technical characteristics parameters by clicking on the link to our website attached above.


Dentistry — Po lymer-based crown and veneering materials (ISO 10477:2020)

ISO 10477:2020


Medical equipment is a fairly broad concept and includes a large number of subcategories. One of these subcategories is the use of certain materials in the treatment of patients. When it comes to dentistry, it is necessary to highlight one of the most significant standards in the industry — EN ISO 10477: 2020. If you operate in the field of dentistry or medical equipment carrying out this activity, we recommend that you have a standard in place to ensure that you fully comply with international standards today.


Dentistry — Port able dental equipment for use in non‐permanent healthcare environment — Part 1: General requirements (ISO 23402–1:2020)

ISO 23402–1:2020


Continuing the topic of the use of medical equipment in the field of dentistry, it is necessary to note such a standard as EN ISO 23402–1: 2020.

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.


Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.


This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.


Since this document contains a large number of amendments and clarifications, we recommend that you consult with professionals in the field of international standardization before purchasing this or that standard.


Ophthalmic impla nts — Intraocular lenses — Part 5: Biocompatibility (ISO 11979–5:2020)

ISO 11979–5:2020


The use of high-quality materials for medical equipment is a guarantee of not only the quality of products but also the health of the people who use it. One standard governing the use of various materials for the medical field is EN ISO 11979–5: 2020.


This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.


The availability of medical equipment standards and their operation is not only a guarantee of competitiveness in the international market, but also an indicator of a high level of responsibility in the activities that you carry out.


Dentistry — Fl uoride varnishes (ISO 17730:2020)

ISO 17730:2020


Test methods are important stages in the use and production of medical equipment; they determine the quality of the final product. One of the standards governing this activity is EN ISO 17730: 2020.


This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.


If you are interested in purchasing this standard and you have additional questions, you can clarify them with our team, which will be happy to help you in selecting the correct document.


Dentistry — Vocabulary (ISO 1942:2020)

EN ISO 1942:2020


Despite the fact that most of the standards have a clear definition of the terms and concepts that they include, it is necessary to understand that some phrases can be perceived quite ambiguously from a legal point of view. That is why, in order to avoid such inconsistencies and create a single, properly functioning international system, additions to documents or so-called standards-dictionaries are created that explain all the terminology used in regulatory documents.


Suction catheter s for use in the respiratory tract (ISO 8836:2019)

EN ISO 8836:2020


Respiratory equipment has been gaining popularity in recent years. In light of recent events, the presence of international standards in this particular subcategory of medicine is very important. One of the documents that regulates this industry is EN ISO 8836: 2020.


This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract.


Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.

Despite the fact that this subcategory is quite narrow-profile, it can be broken down into separate sub-sectors. That is why we recommend that you clarify in more detail the details of the use of the aforementioned medical equipment in order to avoid acquiring the wrong standard.


International standards are the key to the correct operation of the equipment


Since medical equipment is completely different and is used for different degrees and types of diseases. We recommend that you study in more detail the scientific and technological base necessary for your field of activity. If we are talking about saving lives, then the presence of international standards is not just a recommendation, but a necessity. If your company or organization is engaged in the sale or production of this equipment, we recommend that you must clarify all the technical parameters with which you deal in your daily business activities. Stay tuned to the iTeh team to keep abreast of the latest updates in the international standardization of the medical industry.



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