WEPA TOPITEC AUTOMATIC Mode D'emploi page 85

3.4 Duties of device owner
Note
In EFTA countries, the relevant national regulations based on framework
directive 89/391/EEC and the associated specific directives, in particular
2009/104/EC regarding the minimum health and safety precautions in
connection with the operation of equipment by employees, as amended,
apply and must be strictly adhered to.
In Germany, the Ordinance on Industrial Safety and Health of 03/02/2015
(BetrSichV) applies. Also observe the German Ordinance on the Operation
of Pharmacies ApBetrO and the BAK Guidelines.
The device owner is responsible for compliance with all relevant statutory regulations in
connection with
• occupational health and safety (accident prevention regulations, etc.), for example by devising
internal operating instructions, providing personal protective equipment (PPE) and arranging
for preventive check-ups;
• the safety of the equipment (e.g. protective equipment, work instructions, process risk
assessments, and maintenance schedules);
• the handling of hazardous substances;
• the procurement of materials (material safety data sheets, hazardous substances lists);
• product disposal (waste disposal regulations);
• the disposal of the device (decommissioning, waste disposal regulations);
• cleaning (cleaning agents and their disposal);
• the protection of the environment;
• compliance with the ApBetrO, the guidelines published by the German Federal Chamber of
Pharmacists BAK, known as the BAK Guidelines,
and all other relevant statutory regulations.
The device owner is also obliged to
• provide and regularly check the personal protective equipment (PPE):
lab coats, protective gloves, safety goggles, hoods/hairnets, etc.
• carry out regular risk assessments of the individual workplaces, including observation of
hazardous substances and fire risks;
• issue binding operating instructions and train personnel in the safe operation of the device
(training of operating personnel).
• issue work instructions for staff.
• enforce strict rules to ensure that personnel do not operate the device under the influence of
alcohol or other drugs, or when extremely tired.
• implement procedures that ensure that all safety-relevant faults of the device or its
components are reported without delay to the supervisor.
• devise a skin protection and hygiene plan.
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