Individual protection

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

The essential products

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888255

Disposable white polypro gown without pocket

0,90 € HT
Ref: 888255

Disposable white polypropylene gown of 30 gr / m2. Elasticated wrist sewn and closed with 4 snaps. Classi…

Protect pro 7255 In stock
40632

Disposable blouse with zip closure and inside pocket

1,19 € HT
Ref: 40632

Disposable top quality polypropylene gown 40 grams per m2. Hygiene gown with practical and reliable zip c…

Kolmi 3328 In stock
888249

Charlotte disposable white food 100

2,25 € HT
Ref: 888249

Charlotte with clips in non-woven white polypropylene. This charlotte has a heat-sealed latex-free elasti…

Protect pro 3111 In stock
40070

Disposable coveralls type 4 5 and 6 cat III EN14126

4,15 € HT
Ref: 40070

White non-woven polypropylene laminated disposable coverall. Antistatic material. Soft, lightweight and f…

Kolmi 493 In stock
70101

Charlotte disposable clips white per 100

2,49 € HT
Ref: 70101

White disposable clip-on charlotte suitable for use in communities, catering, industry, laboratories, pha…

Kolmi 347 In stock
WLPMG

Weepro max green wetsuit

4,80 € HT
Ref: WLPMG

Disposable coverall waterproof against pesticide and phytosanitary treatments. Weepro max green from Wees…

Weesafe 320 In stock
WLCB

Blue disposable coverall cat III type 5 and 6

2,20 € HT
Ref: WLCB

Disposable coverall in blue category III type 5 and 6 offering maximum comfort (high permeability to wate…

Weesafe 278 In stock
888832

Disposable coverall category 3 type 5 and 6

2,35 € HT
Ref: 888832

3-layer non-woven SMS polypropylene suit: Spunbonded Meltblown Spunbonded. Elastic 3-piece hood. Two-way …

Protect pro 274 In stock
WLB

Weeback ventilated back disposable coverall type 5 and 6

3,45 € HT
Ref: WLB

Disposable coverall with ventilated back Weeback category III type 5 and 6. The ventilated back of the co…

Weesafe 249 In stock
WLJ1

Yellow Weejet wetsuit

7,10 € HT
Ref: WLJ1

The Weejet yellow suit is category III type 3B 4B 5B 6B. Suit suitable for the petrochemical industry, vi…

Weesafe 211 In stock
05108081

Disposable blue food charlotte the 100

4,50 € HT
Ref: 05108081

Blue non-woven polypropylene clip-on cover. This charlotte has a latex-free heat-sealed elastic to preven…

Protect pro 110 In stock
40507
-24%

Kolmi Microporous Disposable Gown

3,90 € HT 2,95 € HT
Ref: 40507

Disposable microporous SMS antistatic PP+PE gown with collar. This gown is category 1 personal protective…

Kolmi 106 In stock
0510807

Charlotte disposable round white 100

4,30 € HT
Ref: 0510807

Single-use round charlotte, white color. Charlotte in non-woven polypropylene with elastic sewn on the ed…

Protect pro 104 In stock
40453EU

Disposable insulation visitor gown 25 grs 10

8,75 € HT
Ref: 40453EU

Disposable visitor dung for insulation and to limit cross-contamination. Reinforced version with weight i…

Kolmi 98 In stock
WLPMP

Weepro max plus disposable coverall

3,95 € HT
Ref: WLPMP

Cat III coverall type 4 5 6 Weepro Max plus is a disposable coverall with waterproof heat-sealed seams. C…

Weesafe 97 In stock
WLC1

Asbestos suit type 5 and 6 Weecover max

3,30 € HT
Ref: WLC1

Weecover max 1 from Weesafe is a special disposable asbestos suit with flat heat-sealed seams for maximum…

Weesafe 95 In stock
888118

White polypropylene disposable coveralls by 50

61,80 € HT
Ref: 888118

Our white disposable coverall in 40g polypropylene for professional work such as painting, risk-free clea…

Protect pro 95 In stock
70103

Charlotte disposable clips green per 100

3,20 € HT
Ref: 70103

Disposable Charlotte green clips suitable for use in communities, catering, industry, laboratory, pharmac…

Kolmi 94 In stock
C12004

Charlotte white clip 10 grs latex free 300

10,65 € HT
Ref: C12004

Charlotte clip color white made in France. Charlotte made from 100% polypropylene spunbonded non-woven fa…

Kolmi 89 In stock
70001

White round Charlotte by 100

4,80 € HT
Ref: 70001

The white round charlotte is made of polypropylene with a sewn and elasticated construction. It is easy t…

Kolmi 87 In stock

Choose fromindividual protection

  • Cap and chef's hat
  • Disposable apron
  • Disposable bibs
  • Disposable Charlotte
  • Disposable coverall
  • Disposable cuff
  • Disposable gown
  • Disposable medical clothing
  • Disposable overshoes
  • Working glasses

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.

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