22.7.2022
EN
Official Journal of the European Union
L 195/53
Field(s) of use
Indoor Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.
For professional use only.
Application method(s)
Method: Manual application Detailed description: Rubbing
Application rate(s) and frequency
Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml).
Contact time: 90 s Dilution (%): Ready-to-use product Number and timing of application: There is no restriction in the number and timing of applications.
No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users
Professional
Pack sizes and packaging material
100, 125, 150, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polyethylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for D-HDL (product 3.1): 100, 125, 150, 500, 1 000 ml in white HDPE bottles with PP flip top caps; 5 000 ml white HDPE canister with HDPE screwed cap.
In addition, exclusively for B-HDL (product 3.3): 700 ml Pouch of transparent PE composite foil with integrated PP pump; 75 ml transparent/white HDPE bottle with PP flip top cap.
4.2.1.
Use-specific instructions for use The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
4.2.2.
Use-specific risk mitigation measures See general directions for use of meta SPC 3
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 3
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 3
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 3