ISO 14971
ISO standard
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ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard,[1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.[2]
The current ISO 14971 edition was published in December 2019.
Background
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,[3] and ISO/IEC Guide 63.[4] The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971.[5]
Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.[6][7]
ISO 14971:2012 was harmonized with respect to the three European Directives associated with medical devices through the three 'Zed' Annexes (ZA, ZB & ZC). The Annex ZA harmonized ISO 14971:2012 with the Medical Devices Directive 93/42/EEC of 1993.[8] The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990.[9] The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998.[10]
The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017.[11] The Annex ZB harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/746) of 2017.[12]
Guidance Documents
ISO 14971 risk management options
Inherent safety by design
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.[15]
Protective measures in the medical device itself or in the manufacturing process
For example:
- 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.” [15]
Information for safety
For example:
Changes in the ISO 14971:2019 edition
The third edition of the standard from 2019 differs from 14971:2007 not only by a new chapter structure, but also by focus on the benefit-risk ratio. For this, the concept of (medical) benefit is now defined. In addition, there is a stronger focus on the "information from the production and the downstream phases". Some explanations or appendices from the previous edition are outsourced in ISO / TR 24971:2019.
History
| Year | Description | |
|---|---|---|
| 1997 | EN 1441 was born in Europe from European Committee for Standardization (CEN) with the title "Medical devices - Risk analysis." Which will be the basis for developing ISO 14971 | |
| 1998 | ISO 14971-1 | |
| 2000 | ISO 14971 (1st Edition) | |
| 2007 | ISO 14971 (2nd Edition) | |
| 2012 | EN ISO 14971 the European Committee for Standardization (CEN) publishes the harmonized European version with respect to the three European directives associated with the medical sector 93/42/EEC, 98/79/EC, 90/385/EEC | |
| 2019 | ISO 14971 (3rd Edition) also published simultaneously in Europe as EN ISO 14971: 2019 | |
| 2021 | EN ISO 14971 the European Committee for Standardization (CEN) publishes the harmonized European version with respect to the two European Regulations associated with the medical sector 2017/745 and 2017/746 |
