ISO 22442-2-2020 PDF

Full title and description

St ISO 22442-2-2020 — Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling. This International Standard specifies requirements for controls on the sourcing, collection and handling (including storage and transport) of animals and tissues used in the manufacture of medical devices that contain materials of animal origin (excluding in vitro diagnostic medical devices).

Abstract

ISO 22442-2:2020 defines requirements to ensure materials of animal origin used in medical devices are sourced, collected, stored and transported under controlled conditions that address biological hazards and transmissible agents (including consideration of transmissible spongiform encephalopathy — TSE — risks for specified species). The document applies where required by the risk management process described in ISO 22442‑1 and excludes the use of human tissues and the establishment of a complete quality management system.

General information

• Status: Published.
• Publication date: 15 September 2020.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.20 (Biological evaluation of medical devices).
• Edition / version: 3rd edition (2020).
• Number of pages: 15 pages (ISO datasheet count).

Scope

This part of ISO 22442 specifies the controls and records expected for sourcing, collecting and handling animal materials intended for use in medical devices, addressing selection of source animals, documentation, traceability, storage and transport conditions, and measures specific to managing risks from infectious agents (notably TSE where relevant). It is intended to be used in conjunction with ISO 22442‑1 (risk management) and applies only to animal‑origin materials (not human tissues) and only where the risk assessment indicates such controls are required.

Key topics and requirements

• Requirements for sourcing and selective sourcing of animals and tissues, with emphasis on reducing TSE risk for bovine, ovine, caprine species and certain other animals (deer, elk, mink, cats).
• Controls for collection, storage and transport of animal tissues and derivatives to maintain material integrity and reduce contamination.
• Traceability, documentation and record-keeping for animal sources and tissue batches.
• Interface with risk management (ISO 22442‑1) — application of risk-based decisions to determine required controls.
• Explicit exclusions and limitations: does not apply to human tissues and does not by itself define a complete quality management system for all production stages.

Typical use and users

Manufacturers of medical devices that contain or are manufactured using animal‑derived materials (e.g., biomaterials, tissue-derived implants, collagen-based products), suppliers of animal tissues and derivatives, quality and regulatory affairs teams, risk managers, and notified bodies/regulators assessing device safety and sourcing controls. Clinical and research groups who develop animal‑derived components may also refer to this standard when defining sourcing and collection procedures.

Related standards

ISO 22442 is a multi-part series. Closely related items include ISO 22442‑1:2020 (Application of risk management) and ISO 22442‑3 (validation of elimination/inactivation of viruses and TSE agents — earlier editions published in 2007); ISO/TR 22442‑4 covers principles for elimination/inactivation of TSE agents and validation assays. National and regional adoptions (EN/ISO equivalents) also exist.

Keywords

animal tissues, animal derivatives, medical devices, sourcing, collection, handling, storage, transport, TSE, transmissible spongiform encephalopathy, traceability, risk management, ISO 22442.

FAQ

Q: What is this standard?

A: ISO 22442-2:2020 is the third‑edition International Standard that defines requirements for controls on sourcing, collection and handling of animal tissues and derivatives used in medical devices.

Q: What does it cover?

A: It covers selection and sourcing of animals/tissues, documentation and traceability, storage and transport controls, and measures to reduce biological risks (including considerations for TSE), to be applied where required by the device risk assessment. It does not cover human tissues and does not establish a full quality management system.

Q: Who typically uses it?

A: Device manufacturers using animal‑derived materials, raw material suppliers, quality/regulatory/risk teams, and conformity assessment bodies. Researchers and clinicians developing animal‑derived products may consult it for sourcing and handling guidance.

Q: Is it current or superseded?

A: The 2020 edition (published 15 September 2020) is the current third edition, which replaced earlier editions (including 2015 and 2007 versions). Users should check for any reviews or updates beyond 2020 before relying on the standard for regulatory submissions.

Q: Is it part of a series?

A: Yes — ISO 22442 is a multi‑part series addressing animal‑derived materials in medical devices; Part 1 covers application of risk management, Part 2 covers sourcing/collection/handling, Part 3 addresses validation of elimination/inactivation of viruses and TSE agents, and Part 4 (TR) covers principles and validation assays.

Q: What are the key keywords?

A: Animal tissues, animal derivatives, sourcing, traceability, TSE, storage, transport, medical device materials, risk management, ISO 22442.