ISO 22442-1-2020 PDF

Full title and description

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management. This International Standard specifies the procedure, in conjunction with ISO 14971, to identify hazards and hazardous situations associated with medical devices manufactured using non‑viable animal tissues or derivatives, to estimate and evaluate the resulting risks, to control those risks and to monitor the effectiveness of the controls.

Abstract

The document applies to medical devices (excluding in vitro diagnostic devices) that incorporate animal‑origin materials that are non‑viable or rendered non‑viable. It addresses typical biological hazards (bacterial, fungal, viral contamination, transmissible spongiform encephalopathy agents, and materials causing pyrogenic, immunological or toxic reactions), describes a risk management process tied to ISO 14971, outlines decision making for residual risk versus medical benefit, and provides guidance (including Annex C levels for certain TSE‑related derivatives). The standard does not set universal acceptability levels for all hazards nor does it cover human tissues.

General information

• Status: Published (current edition).
• Publication date: 15 September 2020 (ISO publication: 2020‑09).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.20 (Biological evaluation of medical devices / Medical science).
• Edition / version: Edition 3 (ISO 22442-1:2020).
• Number of pages: 26 (ISO published PDF length).

Key bibliographic and lifecycle information above is drawn from the ISO bibliographic record and standard national/adoption listings.

Scope

This part of ISO 22442 applies to medical devices (other than in vitro diagnostic medical devices) that are manufactured using animal tissues or derivatives that are non‑viable or have been rendered non‑viable. It specifies requirements and guidance for applying a risk management process (aligned with ISO 14971) to identify hazards related to animal‑origin materials, estimate and evaluate risk, implement risk controls, and assess residual risk in light of expected medical benefit and alternatives. It excludes human tissues and does not itself prescribe a full quality management system.

Key topics and requirements

• Integration of risk management for animal‑derived materials with ISO 14971 risk management principles.
• Identification and analysis of biological hazards: bacterial, fungal/yeast contamination, viral contamination, TSE agents and materials causing pyrogenic, immunological or toxic reactions.
• Assessment and estimation of risks arising from sourcing, processing and use of animal‑origin materials, including assessment of likelihood and severity of harm.
• Selection and implementation of risk control measures, and monitoring of their effectiveness throughout product lifecycle (including post‑market monitoring considerations).
• Decision framework for acceptability of residual risk that balances residual risk and expected medical benefit compared to available alternatives.
• Specific guidance and, for some derivatives, stipulated TSE risk acceptability levels in Annex C (examples: certain tallow derivatives, milk derivatives, wool derivatives, amino acids).
• Clarification that the standard does not set universal acceptability levels for all materials and does not replace quality management system standards (e.g., ISO 13485).

Typical use and users

Primary users are medical device manufacturers, design and regulatory teams, quality and risk managers, suppliers of animal‑derived materials, notified bodies and conformity assessment bodies, and regulatory authorities. The standard is used when establishing risk management files, supplier controls, sourcing policies, biological risk assessments, and when documenting residual risk/benefit decisions for devices that incorporate animal tissues or derivatives.

Related standards

Closely related documents include ISO 14971 (application of risk management to medical devices), ISO 22442‑2 (controls on sourcing, collection and handling of animal tissues and derivatives), ISO 13485 (quality management systems for medical devices), and applicable regional harmonized standards/adoptions (EN/EN ISO versions). The ISO 22442 series (parts 1 and 2) were revised together in 2020.

Keywords

animal tissues, animal derivatives, biological risk, risk management, ISO 14971, transmissible spongiform encephalopathy, TSE, contamination, medical devices, supplier controls, residual risk, Annex C.

FAQ

Q: What is this standard?

A: ISO 22442‑1:2020 is the part of the ISO 22442 series that specifies the application of risk management to medical devices manufactured using non‑viable animal tissues and their derivatives; it provides requirements and guidance for identifying, assessing and controlling biological hazards associated with such materials.

Q: What does it cover?

A: It covers the risk management process related to biological hazards from animal‑origin materials (bacteria, fungi, viruses, TSE agents, pyrogenic/immunological/toxic reactions), the evaluation of residual risk versus medical benefit, and guidance for monitoring the effectiveness of risk controls. It does not cover human tissues and does not itself define a full quality management system.

Q: Who typically uses it?

A: Medical device manufacturers, suppliers of animal‑derived materials, regulatory and compliance teams, notified/conformity bodies, and quality/risk professionals involved in device design, production and post‑market surveillance.

Q: Is it current or superseded?

A: ISO 22442‑1:2020 is the third edition published in 2020 and replaced the 2015 edition; it is the current published edition (under normal periodic review). Users should check national adoption or amendment status for regional harmonized texts.

Q: Is it part of a series?

A: Yes — it is Part 1 of the ISO 22442 series. Part 2 (ISO 22442‑2:2020) addresses controls on sourcing, collection and handling of animal tissues and derivatives; the two parts are intended to be used together for comprehensive risk and supply controls.

Q: What are the key keywords?

A: Animal tissues, animal derivatives, biological hazard, risk management, ISO 14971, TSE, contamination, supplier control, residual risk, medical device safety.