Medical equipment as an object for standardization


The coronavirus has made its own adjustments to global plans, to the plans of economic financial systems, as well as to the development plans for scaling many businesses around the planet. Today, the prevailing number of organizations that have reached significant financial heights operate in the medical sector and make it possible to develop these industries at an ever faster pace. Nevertheless, one should not forget that oversaturation of the market in this industry can lead to an increase in the number of low-quality services and goods, and therefore directly affect the health of all mankind. That is why the number of medical companies is increasing and the number of norms and requirements, respectively, one of which are international standards.

Ophthalmic instruments - Corneal topographers (ISO 19980: 2021)

EN ISO 19980: 2021

With the acceleration of the development of technologies, their exploitation also increases significantly. Nevertheless, despite the large number of positive effects, it should be noted that in the post-industrial development of society, the number of diseases associated with the organs of vision has significantly increased. The medical industry, aimed at eliminating this problem, is developing every day and if we consider technologies in this vein, then they have only a positive effect. Since the introduction of technologies requires certain time expenditures, and therefore financial, their implementation by following the recommendations of certain regulatory documents greatly simplifies this process. One of the most popular and relevant international standards today in the field of ophthalmic instruments is EN ISO 19980: 2021.

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5: 2006)

EN ISO 10651-5: 2021

The medical industry uses a large number of elements to create certain medicines. It should also be noted that despite the innovative development of almost complete detailing of even medical processes, the use of chemical elements such as gas is still relevant, and therefore the equipment associated with this type of technology requires certain safety measures. In order for the treatment to take place in the most effective and safe way not only for the patient, but also for the staff, it is necessary to introduce an appropriate regulatory framework, namely such international standards as EN ISO 10651-5: 2021.

This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use.

This part of ISO 10651 also specifies the requirements for resuscitator sets (3.22). This part of ISO 10651 is not applicable to electrically-powered resuscitators. NOTE ISO 10651-3 covers emergency and transport ventilators.

This international standard regulates a certain category of medical equipment that comes into contact with the use of gases only. That is why, if you are planning to acquire an international standard not only for the regulation of equipment but for the improvement of electronic technologies, you can follow the link to our website and familiarize yourself with the list of all available documents for the medical sector.

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

EN ISO 22413: 2021

The demands on the pharmaceutical industry are just as important as the demands on the entire medical sector. Since pharmaceuticals are one of the last stages in the chain of the medical system from the manufacturer to the consumer, it is this level of interaction that must be regulated in order to maintain the quality that was created at all previous stages. International standardization pays a huge amount of attention to this category of human activity and, as a result, creates appropriate norms and rules to preserve 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 3630-3: 2021)

EN ISO 3630-3: 2021

Interaction with certain equipment requires relevant knowledge, which is obtained through the implementation of advanced training or the introduction of certain regulatory documents. Today, one of the most relevant documents in absolutely any field of human activity is international standardization. When it comes to the field of dentistry and also the details used in one or another equipment, international standardization gives recommendations, as well as technical parameters that are significantly minimized.

And increase the time spent searching for information, and also increases the productivity of the activities being carried out. One of the most striking examples of such international standards is EN ISO 3630-3: 2021.

Maximum documentation - minimum risks

International standardization is exactly the tool that can help your organization achieve not only quality results, but also expand into more global markets. If you have not thought about entering the international market and prefer to remain at the level of local interaction with the consumer, we still recommend purchasing documents that are specialized specifically for your location. After all, they will help you create a well-functioning system in which the risks of a negative impact on human health are significantly minimized and, as a result, the risks of financial losses and possible problems in carrying out activities in general are minimized.