Medical Devices as the Subject of Standardization


Coronavirus has made its own adjustments to global plans, economic and financial systems plans, and development plans to scale many companies around the world. which have reached significant financial heights in the medical sector, allowing these industries to develop ever faster; However, it should not be forgotten that the oversaturation of the market in this industry can lead to an increase in the number of inferior services, goods and therefore have a direct impact on the health of all of humanity. This is why the number of medical companies and the number of norms and requirements, including international standards, are increasing.


Ophthalmological instruments Corneal topograph (ISO 19980: 2021)

EN ISO 19980: 2021


With the acceleration of the development of technologies, their use also increases significantly, however, despite the multitude of positive effects, it should be noted that in post-industrial development of society the number of diseases associated with the organs of vision has increased significantly. The medical industry that aims to eliminate this problem is evolving day by day and if we look at the technologies of this line, then they only have a positive effect, since the introduction of technologies requires a certain amount of time and therefore economic expenditure, theirs Tracking implementation of the recommendations in certain regulatory documents simplifies this process significantly. One of the most popular and relevant international standards in the field of ophthalmic instruments today is EN ISO 19980: 2021.

Lung ventilators for medical purposes Special requirements for basic safety and essential performance Part 5: Gas for emergency ventilators (ISO 10651-5: 2006)

EN ISO 10651-5: 2021


The medical industry uses a variety of elements to make certain drugs. It should also be noted that, despite the innovative development of almost complete details of even medical processes, the use of chemical elements such as gas is still relevant. The implantation associated with this technology requires certain safety measures, so that the treatment is not only for the patient, but also for the most efficient and safest personnel is carried out in an appropriate legal framework, namely: international standards such as EN ISO 10651-5: 2021.


9 87 This part of ISO 10651 specifies the basic safety and performance requirements for gas-fired emergency ventilators (3.10) intended for use on People are determined by first responders. This device is designed for use in an emergency on site and should be constantly monitored by the operator during normal use.


This part of ISO 10651 also specifies the requirements for resuscitation devices (3.22).

This part of ISO 10651 does not apply to electrical ventilators.

NOTE ISO 106513 covers emergency and transport ventilators.


This international standard regulates a certain category of medical devices that only come into contact with gases. You can follow the link to our website and familiarize yourself with the list of all available documents for the medical field.


Transfer devices for pharmaceutical preparations Requirements and test methods (ISO 22413: 2021)

EN ISO 22413: 2021


The requirements of the pharmaceutical industry are just as important as the requirements of the entire medical sector. In the later stages of the medical system chain from the manufacturer to the consumer, this interaction level must be regulated in order to maintain the quality created in all previous stages. Category of human activity and as a result creates appropriate standards and rules to protect people's lives. One of the most relevant documents for this industry today is EN ISO 22413: 2021.


Dentistry Endodontic instruments Part 3: Compactors (ISO 36303: 2021)

EN ISO 36303: 2021

The use of certain devices requires relevant knowledge, which is acquired through further training or the introduction of certain official documents. The most relevant document in any area of ​​human activity is international standardization. When it comes to the field of dentistry and also the details that are used in one or the other device, international standardization gives recommendations as well as technical parameters that are significantly minimized and increase the time spent searching for information and increase productivity The most striking example of this type of international standard is EN ISO 36303: 2021.

Maximum documentation minimum risks

International standardization is exactly the tool that can help your company to achieve not only high quality results, but also to more global ones Expand markets. If you haven't thought about getting into the international market and prefer to stay at the local level of consumer interaction, we recommend purchasing documents that are specific to your location.Ultimately, they will help you create a well-functioning system in which the risks of negative effects on human health are significantly minimized, thereby minimizing the risks of economic loss and potential problems in the conduct of business.

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