ISO specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Annex D.8 to ISO 14971, referred to in 3.4, contains the concept of reducing risks 'as low as reasonably practicable' (ALARP concept). The ALARP concept contains an element of economic consideration. B) However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and various particular.

ISO/TR 24971:2013

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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.

General information

Publication date : 2013-07
Number of pages : 12
:
Quality management and corresponding general aspects for medical devices
ICS :
Medical equipment in general

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ISO 14971 is an ISO standard for the application of risk management to medical devices.^[1] The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51,^[2] and ISO/IEC Guide 63.^[3] The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971^[4] was published by ISO TC 210 to provide expert guidance on the application of this standard.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production.^[5]^[6]

In 2012, a European harmonized version of this standard was adopted by CEN as EN ISO 14971:2012. This version is harmonized with respect to the three European Directives associated with medical devices Active Implantable Medical Device Directive 90/385/EEC^[7], Medical Devices Directive 93/42/EEC,^[8] and In-vitro Diagnostic Medical Device Directive 98/79/EC,^[9] through the three 'Zed' Annexes (ZA, ZB & ZC). This was done to address the presumed compliance with the 3 Directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard.^{[citation needed]}

EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 remains the standard recommended for medical device risk management purposes.

1ISO 14971 risk management options

ISO 14971 risk management options[edit]

Inherent safety by design[edit]

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For example:

Use specific connectors that cannot be connected to the wrong component.
Remove features that can be mistakenly selected or eliminate an interaction when it could lead to use error.
Improve the detectability or readability of controls, labels, and displays.
Automate device functions that are prone to use error when users perform the task manually.^[10]

Protective measures in the medical device itself or in the manufacturing process[edit]

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Free Iso 14971 Standard Pdf File

Incorporate safety mechanisms such as physical safety guards, shielded elements, or software or hardware interlocks.
Include warning screens to advise the user of essential conditions that should exist prior to proceeding with device use, such as specific data entry.
Use alerts for hazardous conditions, such as a “low battery” alert when an unexpected loss of the device’s operation could cause harm or death.
Use device technologies that require less maintenance or are “maintenance free.” ^[10]

Information for safety[edit]

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Provide written information, such as warning or caution statements in the user manual that highlight and clearly discuss the use-related hazard.
Train users to avoid the use error.^[10]^[11]

References[edit]

^ISO Catalogue: Medical devices -- Application of risk management to medical devices
^'ISO/IEC Guide 51:2014 - Safety aspects -- Guidelines for their inclusion in standards'. www.iso.org.
^'ISO/IEC Guide 63:2012 - Guide to the development and inclusion of safety aspects in International Standards for medical devices'. www.iso.org.
^'ISO/TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971'. www.is