Overview
ISO 22442-2:2020 - "Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling" specifies requirements for the sourcing, collection, handling, storage and transport of animal-derived materials used in medical devices (excluding in vitro diagnostic devices). It is intended to be applied where required by the risk management process described in ISO 22442‑1. The standard emphasizes selective sourcing for TSE (transmissible spongiform encephalopathy) risk management, particularly for materials from bovine, ovine, caprine species, deer, elk, mink and cats. It does not cover human tissues and does not prescribe a full quality management system.
Key topics and technical requirements
- Risk-based application: Apply controls as determined by the benefit–risk assessment in ISO 22442‑1.
- Sourcing controls: Specification of species, strain, age, and detailed geographical origin (birth, lifetime locations and slaughter site) with traceability to slaughterhouses.
- TSE considerations: Selective sourcing and Annex A provisions for bovine and other TSE-relevant species; enhanced expectation for validated biochemical testing where applicable.
- Collection and handling: Documented procedures for collection, preservation, handling and hygiene to prevent cross-contamination; requirements for qualified personnel and veterinarian oversight where applicable.
- Storage, transport and labelling: Controls to maintain material integrity during storage and transit, with appropriate labelling and chain-of-custody records.
- Quality system elements (partial QMS): Documented system elements (document control, procedures, records, supplier control and evidence of controls) though not a full QMS standard.
- Traceability and certification: Records and certification requirements for suppliers and processed animal material, plus expectations for inspections and attestation (see Annex B).
Applications and users
ISO 22442-2 is used by:
- Medical device manufacturers that incorporate animal tissues or derivatives (e.g., heart valves, bone substitutes, collagen coatings).
- Suppliers and processors of animal-derived raw materials and specialized industries (gelatine, enzymes).
- Regulatory, quality and procurement teams responsible for supplier qualification, audit and compliance.
- Veterinarians and auditors involved in ante/post-mortem inspection, herd health documentation and closed-herd verification.
Practical benefits include improved supply-chain traceability, reduced biological risk (including TSE), consistent handling controls, and clearer documentation for regulatory submissions and audits.
Related standards
- ISO 22442‑1 - Application of risk management for animal-derived materials
- ISO 22442‑3 - Validation of elimination/inactivation of viruses and TSE agents
- ISO 13485 - Quality management system for medical devices (relevant but not replaced by this part)
Keywords: ISO 22442-2:2020, medical devices, animal tissues, sourcing, collection, handling, TSE risk, traceability, storage, transport, quality system.
