Hygiene Requirements for Data Input Devices in Regulated Industries: Current Regulations & Standards

The EU Regulation (EC) No. 852/2004 on food hygiene stipulates that all equipment used in food production must be easy to clean and disinfect. Key requirements include:

• Surfaces must be smooth, waterproof, and resistant to cleaning chemicals.
• Edges, grooves, or gaps must not allow microorganisms or food residues to accumulate.

This applies not only to machines and work surfaces but also to input devices such as keyboards and touchscreens. Seamless designs, such as those found in glass or silicone keyboards, are particularly effective in reducing contamination risks.

Additionally, EU Regulation (EC) No. 1935/2004 governs materials that come into direct contact with food. If a keyboard is used at production lines, it must be made of food-safe materials that do not release harmful substances into the product.

Relevant Standards:

• EN 1672-2: Specifies hygienic design requirements for machinery and equipment in the food industry.
• ISO 22196: Regulates antibacterial effectiveness of surfaces, relevant for keyboards with antimicrobial coatings.

The Medical Device Regulation (EU) 2017/745 (MDR) sets stringent requirements for medical devices. Input devices used in hospitals, laboratories, or clinics fall under these regulations when they are part of a medical system.

Relevant scenarios include:

• Keyboards in operating rooms or intensive care units, which must be easy to disinfect.
• Control panels in diagnostic devices, which must be usable with sterile gloves.
• Input devices for medical documentation, which are cleaned daily with disinfectants.

The ISO 13485 standard governs quality management for medical devices, ensuring that input devices meet hygiene and quality standards.
The EN 60601-1 standard, a key regulation for medical electrical equipment, ensures that input systems in hospitals and healthcare facilities meet electrical and hygiene safety requirements.

Disinfectant resistance is crucial:
While conventional plastic keyboards can become porous due to aggressive cleaning agents, glass or silicone keyboards remain intact even with frequent disinfection.

Relevant Standards:

• ISO 13485: Quality management for medical devices, including peripheral devices such as keyboards.
• EN 60601-1: Safety requirements for medical electrical equipment.

In pharmaceutical production, Good Manufacturing Practice (GMP) guidelines require that all equipment meets hygienic design standards. Especially in cleanrooms, where air purity and sterility are strictly controlled, input devices must not pose a contamination risk.

Key requirements:

• Keyboards in cleanrooms must be smooth, particle-free, and easy to clean.
• Materials must not release particles or degrade when exposed to disinfectants.
• Design must prevent bacteria and contaminants from accumulating in crevices or gaps.

For this reason, many companies use silicone-sealed or glass keyboard surfaces, which can be completely disinfected without residue.

Relevant Standards:

• GMP (Good Manufacturing Practice): Requirements for hygiene and quality control in pharmaceutical production.
• ISO 14644-1: Cleanroom classification, including material and surface requirements for equipment.

Hygiene regulations in sensitive industries continue to evolve. Three key developments are particularly relevant:

1. Digitization & Contactless Input Systems
   More companies are adopting touch-free technologies to prevent cross-contamination. Gesture control, voice recognition, or capacitive sensor surfaces could complement traditional keyboards in the future.
2. Stricter Hygiene Requirements Following the Pandemic
   COVID-19 has highlighted the need for enhanced cleaning protocols in critical environments. Disinfectant resistance remains a key factor in selecting new input devices.