SA TR ISO 24971-2020 PDF

Full title and description

ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971. This technical report provides non‑mandatory, practical guidance and examples to help manufacturers and other stakeholders apply the risk management requirements of ISO 14971:2019 for medical devices, including hazard identification, risk analysis, risk control, and production/post‑production activities.

Abstract

ISO/TR 24971:2020 is a Technical Report (edition 2) that clarifies and illustrates the application of ISO 14971:2019. It offers explanatory text, illustrative examples and informative annexes (e.g., hazard identification techniques and IVD considerations) intended to support consistent implementation of risk management processes across medical device product life cycles.

General information

• Status: Published (Technical Report).
• Publication date: June 16, 2020 (2020‑06).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.01 (Medical equipment in general).
• Edition / version: Edition 2 (ISO/TR 24971:2020), replaces ISO/TR 24971:2013.
• Number of pages: 87 pages (typical published PDF/print length).

Scope

Provides practical, non‑normative guidance for applying the requirements of ISO 14971:2019 to the risk management of medical devices. Topics include establishing a risk management policy, foreseeable misuse, benefit–risk analysis, selection and implementation of risk controls, evaluation of residual and overall risk, and integration of production and post‑production information into the risk management process.

Key topics and requirements

• Guidance on implementing ISO 14971:2019 risk management requirements (policy, risk acceptability criteria, roles/responsibilities).
• Hazard identification methods and characteristics related to safety (informative annex).
• Risk analysis techniques and examples to support selection and application of risk control measures.
• Clarification of reasonably foreseeable misuse and benefit‑risk analysis principles.
• Recommendations for production and post‑production activities, including feedback and vigilance input to risk management.

Typical use and users

Primary users are medical device manufacturers, regulatory and quality professionals, risk managers, clinical engineers, notified bodies and conformity assessment personnel who need practical guidance to implement ISO 14971:2019 risk management processes. The report is also used by standards committees and consultants supporting device design, verification, validation and post‑market surveillance.

Related standards

Main companion/normative standard: ISO 14971:2019 (Medical devices — Application of risk management to medical devices). Other related standards include ISO 13485 (quality management for medical devices) and regional/adopted versions or CEN prefaces adapting the technical report for European use (PD CEN ISO/TR 24971:2020).

Keywords

risk management, medical devices, ISO 14971, guidance, residual risk, hazard identification, benefit–risk analysis, post‑market surveillance, technical report.

FAQ

Q: What is this standard?

A: ISO/TR 24971:2020 is a Technical Report providing guidance on the application of ISO 14971:2019 for medical device risk management — it is informative (not normative) and intended to help implementers interpret and apply the requirements of ISO 14971.

Q: What does it cover?

A: It covers practical methods and examples for hazard identification, risk analysis, evaluation, risk control, benefit–risk considerations, production/post‑production activities and related topics (including informative annexes with techniques and IVD considerations).

Q: Who typically uses it?

A: Medical device manufacturers, regulatory/quality engineers, risk managers, notified bodies, consultants and standards committees use the report to support implementation of ISO 14971 in design, manufacturing and post‑market activities.

Q: Is it current or superseded?

A: ISO/TR 24971:2020 is the current edition published in June 2020 and it supersedes ISO/TR 24971:2013. Users should check national/adopted versions or amendments in their markets for any regional adaptations.

Q: Is it part of a series?

A: It is a technical report that specifically complements ISO 14971:2019 (the normative risk management standard for medical devices). It is not a multi‑part numbered series but is part of the ISO family of medical device standards maintained by ISO/TC 210 and related committees.

Q: What are the key keywords?

A: Key keywords include risk management, medical devices, ISO 14971, guidance, hazard identification, risk control, residual risk and post‑market surveillance.