EN ISO 22442-1:2020 PDF

Overview

EN ISO 22442-1:2020 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management - specifies how to apply risk management principles to medical devices manufactured using non-viable animal tissues or derivatives. Used together with ISO 14971, it defines a procedure to identify hazards and hazardous situations, estimate and evaluate risks, implement risk controls, and monitor the effectiveness of those controls. The standard addresses biological hazards typical for animal-derived materials while excluding in vitro diagnostic devices and devices using human tissues. Annex C provides specific TSE (transmissible spongiform encephalopathy) acceptability levels for certain derivatives.

Key topics and requirements

• Risk management process in accordance with ISO 14971: identification, analysis, evaluation, control, and residual risk assessment.
• Biological hazards covered: bacterial, fungal (mould/yeast) and viral contamination; TSE agents; and materials causing pyrogenic, immunological or toxicological reactions. Principles also apply to parasites and other pathogenic entities.
• Decision on residual risk acceptability: requires balancing residual risk against expected medical benefit and available alternatives.
• Risk control measures: specific considerations for viruses and TSE agents and for other biological hazards.
• Production and post-production information system: monitoring and feedback mechanisms for effectiveness of risk controls.
• Annexes:
  • Annex A: guidance on application
  • Annex B: graphical risk management representation
  • Annex C (normative): TSE risk acceptability levels for selected derivatives (tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives, amino acids)
  • Annex D: information relevant to TSE risk management

Practical applications

• Incorporating EN ISO 22442-1:2020 into design and development of medical devices that use animal-derived materials to demonstrate systematic biological risk control.
• Defining supplier controls, material sourcing and traceability for animal-origin inputs.
• Informing sterilization, validation, bioburden and TSE mitigation strategies during product development and manufacturing.
• Supporting regulatory submissions and conformity assessment in regions recognizing this standard (CEN adoption confers presumption of conformity with certain EU Directive requirements when cited).
• Structuring post-market surveillance, incident investigation and corrective actions related to biological contamination or adverse immunological/toxic responses.

Who should use it

• Medical device manufacturers, design and risk management teams
• Quality and regulatory affairs professionals working with animal-derived materials
• Supplier qualification and procurement teams for biological inputs
• Notified bodies, auditors and consultants reviewing biological risk controls

Related standards

• ISO 14971 (risk management for medical devices)
• ISO 10993-1 (biological evaluation of medical devices)
• ISO 22442-2 / ISO 22442-3 (related parts on sourcing and processing)
• ISO 13485 (quality management systems - recommended for production controls)

Keywords: EN ISO 22442-1:2020, medical devices, animal tissues, risk management, TSE, ISO 14971, contamination, biological risk, residual risk.