Operating instructions for biological agents template (PDF) under Section 14 BioStoffV
Form for operating instructions under the German Biological Agents Ordinance – scope, agents and hazards, protective measures, behaviour after injuries and accidents, first aid, disposal – with a filling-in guide and a record of the oral safety instruction.
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Anyone whose employees work with biological agents must draw up written operating instructions (Betriebsanweisung) before the activity starts – specific to the work area and the agents occurring there (Section 14(1) of the German Biological Agents Ordinance, BioStoffV). They describe hazards, protective measures, behaviour after injuries, accidents and operational disruptions, first aid and inactivation and disposal. On this basis, employees receive oral safety instruction and confirm it with their signature.
The template follows the structure that DGUV Information 213-016 “Operating instructions under the Biological Agents Ordinance” describes as proven. Page 2 contains a filling-in guide and a checklist before approval, page 3 the record of the oral safety instruction with a list of participants.
What the template contains
- PDF form with header for work area, biological agents, risk group and containment level
- Six sections: scope, hazards, protective measures, injuries and accidents, first aid, disposal
- Filling-in guide for each section with sources and a checklist before approval
- Record of the oral safety instruction with seven topics and a list of participants to sign
How to use the template
- 1
Use the risk assessment
Take the biological agents, risk groups, routes of transmission and defined protective measures from the risk assessment and the register of biological agents. Involve the company doctor – for first aid, post-exposure prophylaxis and vaccination offers, for example.
- 2
Be specific
Write actions rather than general warnings: “Put used needles straight into the sharps container, never recap them” instead of “Take care with needles”. Name gloves and disinfectants by product.
- 3
Post and instruct orally
Post the operating instructions in the work area and give oral instruction using the document – before employees start work and at least once a year. Participants sign on page 3.
Legal basis
- Section 14(1) BioStoffV: written operating instructions specific to the work area and the agents before the activity starts, minimum content, updating
- Section 14(2) and (3) BioStoffV: oral, workplace-specific instruction before starting work and at least once a year, confirmed by signature
- Section 14(4) BioStoffV: additional work instructions at containment levels 3 and 4 and where there is an increased risk of infection
- Section 13 BioStoffV: measures for operational disruptions and accidents as part of the operating instructions
- TRBA 400 no. 10 and DGUV Information 213-016: operating instructions, safety instruction and occupational health advice for work with biological agents
Frequently asked questions
When are operating instructions under the Biological Agents Ordinance mandatory?
Whenever employees carry out activities involving biological agents – with one exception: if exclusively risk group 1 agents without sensitising or toxic effects occur, they are not required (Section 14(1) BioStoffV). This applies to targeted activities in the laboratory as well as to non-targeted activities, for example in care, waste management or agriculture.
What colour are operating instructions for biological agents?
No colour is prescribed. DGUV Information 213-016 recommends a consistent design within the company and mentions a green frame for biological agents as a suggestion – alongside red for hazardous substances and blue for machinery. The content under Section 14 BioStoffV is what is binding.
Is e-learning enough for instruction on biological agents?
No, not on its own. The Biological Agents Ordinance requires oral instruction based on the current operating instructions; content and date must be recorded in writing and confirmed by the employees' signature (Section 14(2) and (3) BioStoffV). Digital media can prepare or supplement the instruction.
You may use and adapt the template freely in your own company and for your own clients. It reflects the regulations named as they stand.
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Biological agents in Germany: risk assessment under the Biological Agents Ordinance
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