ISO 22442-3-2007 PDF

Full title and description

Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. This International Standard specifies requirements for designing, conducting and documenting validation studies that demonstrate elimination and/or inactivation of viral and TSE agents during manufacture of non‑viable medical devices or products derived from animal tissue (excludes in vitro diagnostic devices).

Abstract

ISO 22442-3:2007 provides requirements for the validation of processes intended to remove or inactivate viruses and TSE agents in the manufacture of medical devices containing animal‑derived materials. It covers the need for a literature review, selection of relevant agents and models, study protocols, conduct of elimination/inactivation studies, interpretation of results, and linkage to risk management (see ISO 22442-1). The document does not cover other transmissible or non‑transmissible agents.

General information

• Status: Published; last systematically reviewed and confirmed in 2022, and marked in the ISO lifecycle as "to be revised" (stage 90.92) with an AWI under development.
• Publication date: 2007-12 (published December 2007).
• Publisher: International Organization for Standardization (ISO). National/adopted editions (ANSI/AAMI, national standards bodies) and distributor publications also exist.
• ICS / categories: 11.100.20 (Biological evaluation of medical devices).
• Edition / version: Edition 1 (2007).
• Number of pages: 22 pages (ISO edition pagination; some distributor/adopted editions may show different pagination).

Scope

Applies to medical devices (other than in vitro diagnostic devices) manufactured using animal tissues or derivatives that are non‑viable or rendered non‑viable. It specifies requirements for validating the elimination and/or inactivation of viruses and TSE agents where such validation is required by the device risk management process (per ISO 22442-1). It does not address other transmissible or non‑transmissible agents.

Key topics and requirements

• Risk‑management linkage: validation studies driven by hazards identified in ISO 22442-1 and ISO 14971.
• Literature review: systematic evaluation of published data to identify relevant viruses and TSE agents and to support study design.
• Study protocol design: selection of surrogate agents, matrices, process steps to be challenged, acceptance criteria and controls.
• Conduct of elimination/inactivation studies: experimental methods, replicate testing, and documentation of process conditions.
• Data interpretation and reporting: criteria for demonstrating reduction/inactivation, uncertainty considerations, and traceability to manufacturing conditions.
• Documentation and recordkeeping: formal protocol, raw data, reports and linkage to quality and regulatory submissions.

Typical use and users

Used by medical device manufacturers (R&D, process development, quality assurance, regulatory affairs), contract development and manufacturing organizations (CDMOs), specialized virology and prion testing laboratories, and regulatory reviewers assessing safety of animal‑derived materials in devices. Regulatory authorities (e.g., FDA) reference the ISO 22442 series when evaluating controls and validation for animal‑derived materials.

Related standards

Part of the ISO 22442 series (see ISO 22442-1 — application of risk management; ISO 22442-2 — controls on sourcing/collection/handling; ISO/TR 22442-4 — principles for elimination/inactivation and validation assays). Related guidance and standards include the ISO 10993 biological evaluation series and quality system standards such as ISO 13485; regulatory guidance (e.g., FDA guidance on animal‑derived materials) references ISO 22442.

Keywords

animal‑derived materials, medical devices, virus elimination, virus inactivation, TSE, prion, validation, surrogate virus, risk management, ISO 22442 series, biological safety

FAQ

Q: What is this standard?

A: ISO 22442-3:2007 is an International Standard that sets out requirements for validating the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents in the manufacture of medical devices that use animal‑derived, non‑viable materials.

Q: What does it cover?

A: It covers planning and conducting literature reviews, designing challenge and elimination/inactivation studies, selecting surrogate agents and matrices, executing experiments under defined process conditions, interpreting results against acceptance criteria, and documenting validation to support risk management and regulatory submissions. It does not cover in vitro diagnostic devices or non‑viral/non‑TSE hazards.

Q: Who typically uses it?

A: Device manufacturers (process development, QA/RA), contract testing laboratories, CDMOs, and regulators — essentially anyone responsible for ensuring that animal‑derived materials in devices do not transmit viral or TSE agents. FDA guidance also references the ISO 22442 series for regulatory submissions.

Q: Is it current or superseded?

A: The ISO 22442-3:2007 edition remains the published International Standard; it was last reviewed and confirmed in 2022. However, ISO lifecycle records indicate the document was placed in a "to be revised" stage (90.92) with an AWI under development. Users should verify the current ISO status before relying on it for compliance.

Q: Is it part of a series?

A: Yes — it is Part 3 of the ISO 22442 series addressing medical devices utilizing animal tissues and derivatives. Related parts include ISO 22442-1 (risk management), ISO 22442-2 (sourcing/collection/handling) and ISO/TR 22442-4 (principles and assays for TSE elimination/inactivation).

Q: What are the key keywords?

A: Viral inactivation, virus elimination, TSE, prion, validation, animal‑derived materials, surrogate virus, protocol, risk management, ISO 22442.