ISO TR 24971:2013 PDF

Name: ISO TR 24971:2013 — Medical devices -- Guidance on the application of ISO 14971
SKU: ISO TR 24971:2013
Price: 22.96 EUR
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Medical devices -- Guidance on the application of ISO 14971

Название (английский):

ISO TR 24971:2013

Medical devices -- Guidance on the application of ISO 14971

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 19 июня 2013 г.
Издание:: IEC TR 24971 edition 1 version 1
ICS:: 11.040.01

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Описание (английский):

ISO TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO TR 24971:2013 - "Medical devices - Guidance on the application of ISO 14971" is a Technical Report that clarifies specific aspects of implementing ISO 14971 (medical device risk management). It supplements ISO 14971 by providing practical guidance on how to interpret and apply risk-management requirements across device design, production and post‑production activities. The report is intended to help manufacturers and other stakeholders translate international product safety and process standards into effective risk-control measures.

Key Topics

Role of international product safety standards: How standards (for example IEC 60601 series) can be used as de-facto risk-control measures and when compliance can justify that residual risk is acceptable, unless there is objective evidence to the contrary.

Policy for risk acceptability: Guidance on developing company policies and criteria for deciding when residual risks are acceptable.

Production and post‑production feedback loop: Practical approach to observation, transmission, assessment and action for production and post‑market surveillance to keep the risk-management file current.

Information for safety vs disclosure of residual risk: How to differentiate risk-control communications intended to ensure safe use (e.g., instructions and warnings) from formal disclosures about remaining risks.

Evaluation of overall residual risk: Inputs and considerations for assessing aggregated risks after all controls are applied.

Practical implementation tips

Start by identifying hazards and hazardous situations per ISO 14971 and then check whether relevant product safety standards address them.

Where a standard specifies technical requirements and acceptance criteria (e.g., stability test on a 10° incline or leakage current limits in IEC 60601‑1), manufacturers may rely on conformity testing and design specs as verification of risk control.

For hazards not covered by standards, perform the full ISO 14971 risk-estimation and evaluation cycle.

Integrate post‑production data (complaints, vigilance reports, recalls) into the risk management file and update risk assessments and controls as needed.

Related standards

ISO 14971 (risk management for medical devices)

IEC 60601 series (medical electrical equipment) - examples cited in the report

IEC 62304 (software life-cycle processes)

IEC 62366 (usability engineering)

ISO 10993 series (biological evaluation)

Keywords: ISO TR 24971:2013, ISO 14971, medical device risk management, residual risk, product safety standards, post-production surveillance, risk acceptability.

ISO TR 24971:2013 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Practical implementation tips

Applications

Who should use this standard

Related standards

Технические детали

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

IEC 60601-2-33:2010/COR1:2012

Corrigendum 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and es…

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 62366-1:2015/COR1:2016

Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.