Overview
EN ISO 22442-2:2020 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020) is a CEN-adopted international standard that specifies requirements for the sourcing, collection and handling (including storage and transport) of animals and animal tissues used in medical device manufacture. It applies where the risk management process in ISO 22442‑1 indicates such controls are required. The standard focuses on animal‑origin materials (not human tissue, and not a full quality management system) and emphasizes selective sourcing for TSE (transmissible spongiform encephalopathy)‑relevant species (bovine, ovine, caprine, deer, elk, mink, cats).
Key topics and requirements
The document sets out practical control topics manufacturers and suppliers should address:
- Sourcing: species and strain selection, geographic risk considerations, supplier inspection and certification, and traceability requirements.
- Collection: controlled procedures for tissue harvesting to reduce contamination and biological risk.
- Handling: documented handling procedures, personnel qualifications and training, and record keeping.
- Storage, transport and labelling: conditions for safe storage and transport, packaging and labelling to maintain chain of custody and material integrity.
- Quality system elements and procedures: necessary elements to support controls (documented procedures, personnel responsibilities), while not replacing a full QMS.
- Regulatory alignment: integration with current regulatory requirements, including EU guidance (Annex ZA links to Directive 93/42/EEC and Reg. 722/2012 for TSE controls).
- Annexes: Annex A provides additional requirements specific to bovine and other TSE‑relevant species; Annex B covers certification and attestation.
Keywords: EN ISO 22442-2:2020, controls on sourcing, medical devices animal tissues, TSE risk management, traceability, storage and transport.
Practical applications and users
EN ISO 22442-2:2020 is intended for:
- Medical device manufacturers using animal‑derived materials (e.g., xenografts, collagen products).
- Supply chain partners and tissue suppliers who must demonstrate compliant sourcing and collection.
- Quality assurance, regulatory and compliance teams preparing technical documentation or conformity assessment evidence.
- Auditors, notified bodies and contract manufacturers assessing TSE and biological risk controls.
Typical uses include developing supplier qualification criteria, creating SOPs for tissue collection and handling, implementing traceability and labelling systems, and documenting certifications/attestations required for regulatory submissions.
Related standards
For organizations handling animal‑derived medical device materials, EN ISO 22442-2:2020 provides targeted, actionable requirements to manage biological and TSE risks across sourcing, collection and handling activities.
