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DIN EN12740 - Guidelines for the treatment, inactivation and testing of waste

DIN 30739 - Containers for infectious waste with a nominal volume of 30 l to 60 l

DIN 58956-10 - Medical microbiology; medical microbiology laboratories; safety labeling

DIN 58956-3 - Medical microbiology; medical microbiology laboratories; requirements for the organization plan

DIN 58956-5 - Medical microbiology; medical microbiology laboratories; requirements for the hygiene plan

If you have a permit to work with pathogens and you want to take up this activity for the first time, you must notify the competent authority.

The term "pathogens" refers to agents capable of reproduction. These include, for example

• viruses
• bacteria
• fungi
• parasites
• or other biologically transmissible agents

These can cause an infection or a transmissible disease in humans.

If you, as the responsible person or permit holder, intend to take up activities with pathogens, whether without a permit or subject to a permit, you must notify the competent authority.

The obligation to notify applies to new activities that have not yet been registered. However, it also applies if this activity has already been reported previously by another responsible person or permit holder. The activity is only deemed to have started if the responsible person has never previously worked with the pathogen.

Employees who work under the supervision of a person who has the required permit for activities involving pathogens are not required to notify the authorities.

Activities with pathogens are deemed to be

• Experiments with pathogens capable of reproduction,
• microbiological tests and methods for the detection of pathogens that are subject to mandatory reporting using process steps for the targeted enrichment or multiplication of pathogens.

Even if no permit is required, a person working with pathogens must still report this activity.

• certified copy of the permit in accordance with the Infection Protection Act, if this was issued by another authority, or information on exemption from a permit
• Information on the nature and scope of the intended activities
• Information on disposal measures:
  • Listing or naming of the pathogens
  • Description of the disposal routes and disposal procedures for infectious waste
• Information on the presence of an animal house
• Information on the condition of the rooms and facilities:
  • Submission of the floor plan with functional designation of the rooms, i.e. designation of the floor, representation of the access routes,
  • Designation of the laboratory rooms for microbiological work,
  • Description of the function of the laboratory rooms.
  • Description of the boundaries to other areas in which no activities involving biological agents of the specified risk group are carried out.
  • An assessment of the risk and assignment of the activities to a protection level
  • Description of the room equipment and the room layout. A detailed description of the work rooms is required, in particular a description of the surfaces, laboratory benches, installations, ventilation systems, windows, desks.
  • Description of the supply and disposal areas, ancillary rooms, any animal stalls and technical equipment.
  • Preparation of a list of laboratory equipment with location details, in particular a description of the steam sterilizer used for the disposal of biological agents.
  • Information on maintenance, effectiveness checks and description of the waste containers for the disposal of microbiological waste.
• Description of the protective measures:
  • Evidence of protective measures for targeted and non-targeted activities involving biological agents in laboratories
  • Presentation of the labeling of workplaces, in particular the placement of doors, collection containers and furnishings with the biohazard symbol
• Presentation of the operating instructions
• Presentation of the hygiene plan
• Information on the presence of an animal shed

• Permission or exception or exemption
• There is no risk to public health. The main reasons for this are
  • suitable rooms or facilities are available for the type and scope of the activities and
  • the conditions for safe disposal are met.

The activity must be notified at least 30 days before the intended commencement of activities.

The activity may only commence if the notification is complete and the activity is permitted after the documents and premises have been checked.

All activities involving pathogens, including activities that do not require a permit, must be notified.

• Activities with pathogens Notification
• Activities involving pathogens must be notified to the competent authority before commencement
• activities with pathogens that do not require a permit are also subject to notification
• Responsible persons or permit holders are subject to the notification requirement
• Employees are not subject to notification
• Responsible: competent authority