AS ISO 14971-2020 PDF

Full title and description

AS ISO 14971:2020 — Medical devices — Application of risk management to medical devices. This Standards Australia adoption (AS ISO 14971:2020) implements the third edition of the international ISO 14971 risk‑management standard (ISO 14971:2019), providing requirements for a systematic process to identify hazards, estimate and evaluate risks, implement and verify risk controls, and monitor effectiveness through production and post‑production phases for medical devices (including SaMD and IVDs).

Abstract

AS ISO 14971:2020 specifies terminology, principles and a comprehensive risk‑management process for medical devices across their entire lifecycle. The normative requirements focus on risk analysis, risk evaluation, risk control (including residual risk evaluation and benefit‑risk analysis), and requirements for production and post‑production information and monitoring. Guidance for interpretation and application is provided in the companion technical report ISO/TR 24971:2020.

General information

• Status: Published.
• Publication date: 26 June 2020 (AS adoption of ISO 14971:2019).
• Publisher: Standards Australia (adoption of the international ISO standard).
• ICS / categories: 11.040.01 — Medical equipment and devices / medical technology.
• Edition / version: AS first edition (AS ISO 14971:2020) — adopts ISO 14971 third edition (ISO 14971:2019).
• Number of pages: 37 pages (AS published PDF).

Scope

Specifies requirements for a risk‑management system applied to medical devices throughout their lifecycle: from design and development through production, distribution, installation, servicing and disposal. The standard addresses risks to patients, users and others (including property and environment), and covers device types such as conventional medical devices, software as a medical device (SaMD) and in vitro diagnostic devices (IVDs). Normative requirements are separated from guidance, the latter being available in ISO/TR 24971:2020.

Key topics and requirements

• Risk‑management process: establish policy, planning (risk management plan), and a documented risk‑management file.
• Hazard identification and foreseeable misuse: systematic identification of hazards associated with intended use and reasonably foreseeable misuse.
• Risk analysis and estimation: identify hazardous situations, estimate severity and probability, and document risk analysis.
• Risk evaluation and acceptability criteria: apply pre‑defined acceptability criteria and decide on need for risk controls.
• Risk control measures: implementation, verification of effectiveness, and documentation of residual risk.
• Benefit‑risk analysis: evaluation of overall residual risk in relation to clinical benefits where applicable.
• Production and post‑production activities: requirements for gathering and using production and post‑production information (post‑market surveillance) to update risk management.
• Records and reporting: maintain risk‑management file, traceability of decisions, and documentation to support regulatory submissions and audits.

Typical use and users

Primary users are medical device manufacturers (design, R&D, regulatory affairs, quality and clinical teams). Secondary users include notified bodies/ conformity assessment bodies, regulatory authorities, auditors, risk‑management consultants, and health‑care organisations involved in device selection and procurement. The standard is used to demonstrate systematic risk management for regulatory compliance, product submissions, design verification/validation, and post‑market surveillance.

Related standards

Key related documents include ISO/TR 24971:2020 (guidance on application of ISO 14971), ISO 13485 (quality management systems for medical devices), relevant IEC usability and electrical safety standards (for example IEC 62366‑1 for usability), and regional/adopted versions or amendments such as EN ISO 14971:2019 with subsequent amendments. These documents are commonly used together to meet regulatory requirements.

Keywords

risk management; medical devices; hazard identification; risk analysis; risk evaluation; risk control; residual risk; benefit‑risk; post‑market surveillance; SaMD; IVD; risk‑management file.

FAQ

Q: What is this standard?

A: AS ISO 14971:2020 is Standards Australia’s adoption of ISO 14971:2019, the international standard that specifies requirements for applying risk management to medical devices.

Q: What does it cover?

A: It covers the full risk‑management process for medical devices — from hazard identification and risk analysis to implementing and verifying risk controls, evaluating residual risk (including benefit‑risk analysis), and managing production and post‑production information. Guidance for applying the requirements is provided in ISO/TR 24971:2020.

Q: Who typically uses it?

A: Device manufacturers (design, quality, regulatory and clinical teams), conformity assessment bodies, regulators, auditors, and consultants use the standard to build and demonstrate compliant risk‑management systems.

Q: Is it current or superseded?

A: The international base standard ISO 14971:2019 is the third edition (published December 2019) and is the current edition; AS ISO 14971:2020 is the Australian adoption published in June 2020. For interpretation and guidance, ISO/TR 24971:2020 was published to accompany the 2019 edition. Users should check national/regional amendments or later corrigenda for any jurisdiction‑specific changes.

Q: Is it part of a series?

A: Yes. ISO 14971 is supported by guidance and related standards — notably ISO/TR 24971:2020 for application guidance, and it is commonly used alongside standards such as ISO 13485 and relevant IEC standards (e.g., usability and electrical safety standards) to achieve full regulatory compliance.

Q: What are the key keywords?

A: Risk management, hazard identification, risk analysis, risk control, residual risk, benefit‑risk analysis, post‑market surveillance, medical devices, SaMD, IVD.