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Personal protection (PPE) for staff: a major issue
Regulation EU2016/425
PPE Personal Protective Equipment is a device 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.
European regulation 2016/425 deals with the obligations of manufacturers of Personal Protective Equipment.
General CE requirements
- Ergonomics, Safety of PPE (materials, health, etc.), Comfort and efficiency factor (adaptation to morphology, lightness, solidity, etc.), Technical instructions for PPE
CE common requirements
- Adjustments, aging, rapid intervention...
Requirements specific to particular risks CE
- Slips, falls from heights, heat, cold, radiation...
Notified bodies: independent and notified by the State.
They validate the products tested according to the standards, if they exist, for European standards.
They check that the PPE passes the required performance tests, but also check the marking of the product and the packaging according to the requirements, the content of the manufacturer's technical instructions, the implementation of a quality system to control the PPE of category 3.
Several manufacturers may have the same notified body number. Each notified body has its own number and can audit several manufacturers.
What does the EU regulation say?
EU Regulation 2016/425 of March 9, 2016 defines the categories of PPE in its appendix 1:
PPE category 1 Minor risks
PPE category 2 Intermediate risks
PPE category 3 Mortal risks, irreversible damage
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The essential products
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Ref: 40.632
1,25€ HT
1,25€ HT
High-quality disposable gown made of 40 grams per square meter polypropylene. Hygiene gown with a practic…
2541 In stock
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Ref: 888255
0,85€ HT
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Disposable white polypropylene gown of 30 gr / m2. Elasticated wrist sewn and closed with 4 snaps. Classi…
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2,40€ HT
2,40€ HT
Charlotte with clips in non-woven white polypropylene. This charlotte has a heat-sealed latex-free elasti…
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Ref: WL-CB
2,45€ HT
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Disposable coverall in blue category III type 5 and 6 offering maximum comfort (high permeability to wate…
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Ref: WL-PMP
4,40€ HT
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731 In stock
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Ref: WL-C1
3,65€ HT
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Weecover Max 1 from Weesafe is a special disposable asbestos coverall with flat-sealed seams for maximum …
715 In stock
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Ref: WL-PMG
5,35€ HT
5,35€ HT
It helps to ensure the protection of operators during treatment operations and protects agents from phyto…
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Ref: WL-B
3,80€ HT
3,80€ HT
Disposable coverall with ventilated back Weeback category III type 5 and 6. The ventilated back of the co…
622 In stock
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Ref: 70.101
2,65€ HT
2,65€ HT
White clip model suitable for use in communities, catering, industry, laboratories, pharmaceutical indust…
434 In stock
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Ref: WL-J1
7,85€ HT
7,85€ HT
Model offers double protection with a first zipper covered with a flap, and a second zipper also covered …
193 In stock
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Ref: WA-KAN
30,90€ HT
30,90€ HT
Disposable protection kit for work in the presence of asbestos. This kit is fully adapted to asbestos rem…
106 In stock
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Ref: 40.507
2,90€ HT
2,90€ HT
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102 In stock
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Ref: 40.453EU
4,95€ HT
4,95€ HT
Disposable visitor dung for insulation and to limit cross-contamination. Reinforced version with weight i…
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Ref: 888118
68,15€ HT
68,15€ HT
Our white disposable coverall in 40g polypropylene for professional work such as painting, risk-free clea…
75 In stock
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Ref: J40451
7,30€ HT
7,30€ HT
Disposable disposable gown of insulation in green polypropylene. Gown worn by nursing staff and visitors …
69 In stock
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Ref: 70.103
3,40€ HT
3,40€ HT
A green clip suitable for use in communities, catering, industry, laboratories, pharmaceutical industry..…
65 In stock
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Ref: 0510807
4,55€ HT
4,55€ HT
Single-use round charlotte, white color. Charlotte in non-woven polypropylene with elastic sewn on the ed…
64 In stock
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Ref: 70.102
3,40€ HT
3,40€ HT
Disposable blue hairnet with clips, suitable for use in community settings, catering, industry, laborator…
51 In stock
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-100%
Ref: 70.001
5,05€ HT
5,05€ HT
Round and white in color, it is made of polypropylene with a sewn and elasticated construction. It is eas…
45 In stock
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Ref: J40452
7,25€ HT
7,25€ HT
Disposable disposable insulating gown in white polypropylene. Gown worn by nursing staff and visitors ove…
44 In stock
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Ref: 888260
8,35€ HT
8,35€ HT
Disposable white polypropylene cap with visor. Adapted to the HACCP method. Charlotte non-woven polypropy…
40 In stock
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Ref: 0614828BLR
35,40€ HT
35,40€ HT
Blue visitor's blouse in non-woven polypropylene with back and neck strap closure. Packaged in a bag of 2…
35 In stock
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Ref: C12001
9,25€ HT
9,25€ HT
White clip-on model made in France. Made from 100% polypropylene spunbonded non-woven fabric. Charlotte w…
33 In stock
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Ref: 05108081
4,75€ HT
4,75€ HT
Features a latex-free heat-sealed elastic to prevent allergies. Clip-on model in blue polypropylene non-w…
29 In stock
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Ref: 88810500
37,30€ HT
37,30€ HT
Disposable protection kit for work in the presence of asbestos. White SMS non-woven coverall. The kit con…
20 In stock
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Ref: 888251
6,20€ HT
6,20€ HT
Protecting heads with a disposable paper cap reduces the risk of hair falling into food preparations or p…
19 In stock
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Ref: 70.112
10,70€ HT
10,70€ HT
Model with double "special comfort" elastic that ensures the user an excellent fit. Clip system is to be …
12 In stock
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Ref: C13600
30,15€ HT
30,15€ HT
Universal disposable viscose surgeon cap for hospital and medical use. This disposable cap complies with …
11 In stock
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Ref: J40453
7,25€ HT
7,25€ HT
Disposable disposable insulating gown in sky blue polypropylene. Gown worn by nursing staff and visitors …
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Ref: 888274
4,80€ HT
4,80€ HT
Disposable chef's hat in extra white crepe paper. Openwork bottom that improves the breathability of the …
8 In stock
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Ref: 888272
68,80€ HT
68,80€ HT
Visitor kit including a polyethylene blouse with hood and snap buttons, a cap, a paper mask, a pair of po…
7 In stock
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Ref: C12101
9,10€ HT
9,10€ HT
Usable in pharmaceutical, industrial, agri-food, medical environments... The assembly is carried out by u…
7 In stock
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Ref: C12201
9,10€ HT
9,10€ HT
Can be used in pharmaceutical, industrial, food, medical environments, etc. Its great extensibility allow…
5 In stock
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-100%
Ref: C12103
10,95€ HT
10,95€ HT
Blue clip-on style, made in France. Features a latex-free synthetic elastic band and no hem for enhanced …
4 In stock
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Ref: C13700
28,30€ HT
28,30€ HT
Universal disposable surgeon's cap in viscose for hospital and medical field. This disposable cap complie…
4 In stock
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Ref: 888273
132,30€ HT
132,30€ HT
Polyethylene visitor coat with hood, 15 micron thickness. Length = 160 mm (with hood) / Width = 70 mm. Pr…
4 In stock
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Ref: 20.909S
49,90€ HT
49,90€ HT
Disposable baby bib in white wadding / PE 24 gr/m2 small model made in France. The SafeCare PE + wadding …
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Ref: 20.910S
98,60€ HT
98,60€ HT
Large size white cotton and polyethylene disposable baby bib made in France by Kolmi Medicom. Dimensions …
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Ref: 178697
129,00€ HT
195,45€ HT
Dunicel bib on the theme of the sea. This bib is ideal for seafood themed restaurants; Duni quality for m…
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Ref: A69955
175,35€ HT
175,35€ HT
Waterproof insulation gown to protect healthcare professionals and patients from cross infection. Compli…
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Ref: 20927
94,10€ HT
176,40€ HT
Disposable blue bib wadding / PE 35 gr / m2. Dimensions: 49x38 cm. Very practical, the bib is resistant t…
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Ref: C12004
11,20€ HT
11,20€ HT
Latex-free synthetic elastic without hem for greater comfort for agents. White clip-on model made in Fran…
60 Available on 17/07
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Focus on individual protection
PPE what you need to know
EU Regulation 2017/745 personal protective equipment
Since May 2021, European Directive 93/42 on medical devices has given way to Regulation (EU) 2017/745.
common to all member states.
• Reasons for a change
The European Directive 93/42/EEC is a regulatory text drafted by the European Union, applied since 1993, giving common indications concerning the placing on the market of medical devices. This directive, applicable to all member states of the European Union, has been enriched by other directives for nearly 25 years. Each of these directives has been transposed into the legislation of each member state of the European Union. This thus leaves free rein to the interpretation of each member state, concerning the obligations of placing on the market of medical devices.
In April 2017, the European Parliament voted to implement a new text aimed at unifying all medical device players under a single regulation, more comprehensive in line with the current technological context.
This new regulation aims to improve traceability and transparency at European level, but also to be able to monitor notified bodies more closely. The regulation on medical devices came into force on 26 May 2017, and has been applied since 26 May 2021.
This transition must be applied by companies but also by notified bodies.
What changes for PPE?
The regulation modifies the scope of medical devices, significantly strengthens their evaluation criteria and procedures , as well as the responsibilities of the various actors.
? reinforced procedures: the regulation is no longer transposed into the health code of each country of the European Union but must be applied as is. This avoids disparities between the different notified bodies and Member States in terms of the requirements to be met.
? improved monitoring - EUDAMED: Among the notable changes, a new post-certification monitoring system is being implemented from May 26, 2021 in order to identify each medical device according to its own code called "UDI" (Unique Device Identification). All of this data is listed in the new European database called EUDAMED.
This “serial number” specific to each medical device will allow very precise traceability.
This new feature will be very useful during recalls of certain devices and in particular with the aim of assessing as quickly as possible the number of people affected by the incident.
? clinical evaluations: A more precise framework for clinical evaluations and investigations for MDs before they are placed on the market.
Personal protection for medical devices
MDs are divided into four classes based on their risk level :
- Class I Low risk level
- Class IIa Medium degree of risk
- Class IIb High risk potential
- Class III Very serious risk potential
The rules to be followed to determine the class of the MD are set out in Annex VIIII of Regulation 2017/745 and take into account the duration of use, the invasiveness or not and the type of invasiveness, the possibility or not of reuse, the therapeutic or diagnostic aim and the part of the body concerned. Non-sterile class I MDs or those not having a measuring function are self-certified by the manufacturer. For other devices; the intervention of a notified body is systematic for the CE certification process.