REGULATION & STANDARDS

Complex design includes the highest level of risk, otherwise defined as irreversible and lethal risk.Disposable gloves in this category are typically gloves that provide protection against chemicals and microorganisms.
The following normative references apply to these gloves: ISO 21420:2020 (general requirements for protective gloves), ISO 374-1: 2016+A1:2018 (terminology and performance requirements for chemical risks) and ISO 374-5: 2016 (terminology) and performance requirements for biological risks).

 

Complex design makes regular inspection by an external organisation mandatory, the so-called notified body. The four digits below the CE mark clearly identify the notified body (e.g. 2797 = BSI, 2777 = SATRA, 0123 = TÜV etc.). The notified body validates the quality assurance system used by the manufacturer.

 

In addition, disposable gloves registered as a complex design are usually marked with the pictograms of the standards to which they have been tested.

 

REFERENCE SCOPE
Regulation (EU) 2016/425

 

General requirements for the design and manufacture of Personal Protective Equipment (PPE).

 

 

Regulation (EU) 2017/745

 

MDD - Medical Devices Directive

 

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