Medical devices and diagnostics international standardization


Today technical development is perpetually increasing pace of development. Moreover, each technological company is attempting to focus its main space of ​​activity specifically on those components of human life that may be primarily helpful for the event of our planet on a worldwide scale and within the long term. One among the foremost profitable, because of its constant demand, is that the client sector of medicine, which incorporates each the assembly of medicines and therefore the instrumentation necessary for the implementation of patient treatment processes. Medical analysis is gaining momentum in achieving distinctive means, and technology can extend people' lives for years to come. recent books regarding the fantastic prospects of technology, together with medical ones, are returning true like ne'er before. Nevertheless, pains for the distinctiveness of innovative achievements and patent profits, one shouldn't forget that drugs is primarily aimed toward saving human life, that is why this trade features a sizable amount of international standards for enterprises that act with numerous varieties of medical instrumentation and analysis activities, with which we'll introduce you today.

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated supermolecules

CEN/TS 17688-2:2021

Before this or that instrumentation is delivered to production, bound necessities are created, according to that this equipment is selected. that's why the presence of international commonplaces greatly simplifies the structure parts of building a system once introducing new technologies. One such international standard for diagnostic activities is CEN/TS 17688-2:2021.


This document offers tips on the handling, documentation, storage and process of fine needle aspirates (FNAs) meant for protein examination throughout the pre-examination part before a molecular examination is performed.


This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine proteins isolated from FNAs. It is conjointly meant to be utilized by laboratory customers, in vitro medicine developers and manufacturers, biobanks, establishments and industrial organizations playacting medical specialty research, and restrictive authorities.


Numerous dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA diagnostic assay or FNA B) and don't seem to be coated during this document, however in EN ISO 20184-2, Molecular in vitro diagnostic examinations - Specifications for pre- examination processes for frozen tissue - half 2: Isolated supermolecules and EN ISO 20166-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for solution fastened and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins.

This document isn't applicable for protein examination by immunohistochemistry.

NOTE International, national or regional laws or necessities also can apply to specific topics coated during this document.


A feature of this commonplace is not solely that it characterizes a precise kind of medical equipment, however also regulates the foundations and regulations related to transportation and storage. That is why if your company uses the above parts in its activities, we have a tendency to advocate that you simply have this commonplace obtainable while not fail.

Medicine - operative lights (ISO 9680:2021)

EN ISO 9680:2021

Medicine doesn't stand still within the implementation of technology, and is one among the foremost sought-after medical classes today. because of the very fact that this a part of human action involves the employment of an outsized variety of apparatus of assorted sizes and purposes, therefore, there's a necessity to make such international standards as EN ISO 9680:2021.


This document specifies necessities and take a look at strategies for operative lights used in the dental workplace and meant for illuminating the oral fissure of patients. It conjointly contains specifications on the directions to be used, marking and packaging.


This document applies to operating lights, no matter the technology of the sunshine source.


This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights that are specifically designed for use in oral surgery.


Operative lighting affects the standard of the final result and, as a result, the health of the patient, which is why it ought to be noted that the presence of this international commonplace within the implementation of dental activities isn't a recommendation, however a compulsory aspect.

Medical standards as a guarantee of safety

Today, the range of the quantity of medical instrumentation creates the requirement for constant regulation by restrictive documents. Since the planet is globalizing, the interaction is actively disbursed between countries, inflicting the need to make international documents that regulate at the international level. These documents are international standards. If your company or organization is concerned regarding the image and security issues, then the acquisition of international standards for the scope of your activity cannot solely create it attainable to create a well-functioning system taking into consideration all risks, however conjointly scale it by seizure new markets in accordance with all norms and rules.

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