Blog Archives - MONDIALISTO - Your health and industry purchasing partner https://mondialisto.com/en/category/blog/ Supplier of medical devices (MD) for healthcare professionals, and, Personal protective equipment (PPE) pour l'Industrie. Thu, 03 Feb 2022 13:55:12 +0000 en hourly 1 https://wordpress.org/?v=6.9.4 https://mondialisto.com/wp-content/uploads/2019/03/globe-mondialisto-100x100.png Blog Archives - MONDIALISTO - Your health and industry purchasing partner https://mondialisto.com/en/category/blog/ 32 32 shopengine_activated_templates a:0:{} Personal protective equipment https://mondialisto.com/en/les-equipements-de-protection-individuelle/ Thu, 12 Aug 2021 08:24:31 +0000 https://mondialisto.com/?p=7076-en Personal protective equipment (PPE) In this article, find out everything there is to know about personal protective equipment. Their different uses, categories and importance. What is personal protective equipment ? PPE are "devices or means intended to be worn or held by a person in view of […]

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Personal protective equipment (PPE)

In this article, find out everything there is to know about personal protective equipment. Their different uses, catégories et importances.

What is Personal Protective Equipment ?

PPE are "devices or means intended to be worn or held by a person in order to protect him against one or more risks likely to threaten his health or safety". (Labor Code article R. 4311-8).

Their use should only be considered in addition to other measures ofelimination or of risk reduction. C’est à partir de l’évaluation des risques menée dans l’entreprise que doit être engagée la réflexion relative à l’utilisation des EPI.

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]]> Medical devices https://mondialisto.com/en/les-dispositifs-medicaux/ Thu, 12 Aug 2021 07:56:23 +0000 https://mondialisto.com/?p=7066-en Medical devices (MD) Posts by ; their categories, their uses, their different classifications.  Qu’est-ce qu’un dispositif médical ? By medical device is meant “any instrument, apparatus, equipment, matter, product, with the exception of products of human origin, or other item used alone or in combination, including accessories […]

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Medical devices (MD)

Posts by ; their categories, their uses, their different classifications.

What is a medical device ?

We hear by medical device “any instrument, apparatus, equipment, matter, product, with the exception of products of human origin, or other item used alone or in combination, including the accessories and software necessary for its proper functioning, intended by the manufacturer for medical use in humans and whose major desired action is not obtained by pharmacological means. Software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes is also a medical device”.

Source : Publication of the French health code (article L.5211-1)

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The definition of a medical device is common to all member states of the European Union (Article 1 of the Medical Device Directive). The medical devices market is very large and the sector very innovative. The industrial fabric is multiple and diversified, composé à la fois de grandes multinationales et de petites et moyennes entreprises.

Dressings, corrective lenses, condoms, thermometers, pacemaker, medical scanner : the term “medical device” (MD) brings together a very large number of products of various nature and destination. According to estimates by the World Health Organization (WHO), today we count approximately 10 000 categories of medical devices, either between 90 000 and 1,5 millions de produits différents dont la sécurité et les performances sont garanties par la législation Européenne.

The different classes of medical devices

Medical devices are classified according to the level of risk associated with their use (duration of use, exposed body part, inside or outside the body) and the potential public health risks associated with their use (class I to III).

I
Lowest risk class :

Compresses, glasses, the crutches,
etc.

II a
Moderate/measured potential risk :

Contact lenses, ultrasonic devices, dental crowns, etc.

II b
Potential high/significant risk :

Condoms, lens disinfection products, etc.

III
Highest risk class :

Breast implants, hip prostheses, stents, etc.

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