ISO 22442-1:2020

Overview

ISO 22442-1:2020 - Medical devices utilizing animal tissues and their derivatives (Part 1) - provides requirements and guidance for the risk management of medical devices that incorporate non‑viable or rendered non‑viable materials of animal origin. Intended to be used in conjunction with ISO 14971, this standard focuses on identifying hazards, estimating and evaluating risks, controlling those risks, and monitoring the effectiveness of controls across the device lifecycle. It does not apply to in vitro diagnostic devices or devices using human tissues.

Key topics and technical requirements

• Scope and applicability
  • Applies to medical devices (including active implantable devices) containing animal‑derived materials that are non‑viable.
  • Excludes in vitro diagnostics and human tissues.
• Risk management process
  • Requires manufacturers to follow ISO 14971 procedures and maintain a risk management file.
  • Emphasizes hazard identification, risk analysis, evaluation, control, and residual risk assessment.
• Typical hazards addressed
  • Contamination by bacteria, moulds, yeasts
  • Viral contamination and virus inactivation/elimination measures
  • Transmissible spongiform encephalopathy (TSE) agents
  • Pyrogenic, immunological or toxicological reactions from animal‑derived material
• Special requirements
  • Annex C: normative guidance on TSE risk acceptability levels for specific derivatives (e.g., tallow derivatives, milk derivatives, wool derivatives, amino acids, animal charcoal).
  • Annex A/D: informative guidance and additional information for applying the standard and managing TSE risk.
• Documentation and monitoring
  • Requires documentation of risk control decisions and a decision process for residual risk acceptability that balances residual risk against expected medical benefit.
  • Recommends production and post‑production information systems to monitor control effectiveness.

Practical applications and users

• Who uses ISO 22442-1
  • Medical device manufacturers using animal‑derived materials (e.g., heart valves, collagen coatings, bone substitutes, hemostatic agents).
  • Regulatory and quality teams assessing biological safety and risk acceptability.
  • Design and clinical evaluation teams performing benefit‑risk analysis involving animal materials.
• Why it matters
  • Helps demonstrate due diligence in identifying and controlling biological hazards unique to animal‑origin materials.
  • Supports regulatory submissions and conformity assessment when used alongside ISO 14971 and ISO 10993 for biological evaluation.
  • Informs sourcing and process validation efforts later covered by ISO 22442‑2 and ISO 22442‑3.

Related standards

• ISO 14971 - Application of risk management to medical devices (mandatory companion)
• ISO 10993‑1 - Biological evaluation of medical devices
• ISO 22442‑2 - Controls on sourcing, collection and handling
• ISO 22442‑3 - Validation of elimination/inactivation of viruses and TSE agents
• ISO 13485 - Quality management systems for medical devices (referenced guidance)

Keywords: ISO 22442-1, risk management, medical devices utilizing animal tissues, TSE, virus inactivation, ISO 14971, biological hazards, residual risk.