A Look at the ISO 13485 and ISO 14971 updates

International Medical Device Standards: A Look at the ISO 13485 and ISO 14971 updates

The term medical device covers a vast range of equipment, from simple tongue depressors to hemodialysis machines. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. The International Medical Device Standard is something that is used for the mapping of technical issues and concerns, with regard to regulatory aspects of standards developed by some major international standardization committees. 

Medical devices are subject to strict general controls and procedural regulations.  The development and use of standards is vital to ensuring the safety and efficacy of medical devices.  Numerous regulatory agencies and standards organizations collaborate to establish the accepted standards for medical equipment.  Standard‐setting activities include the development of performance characteristics, testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labelling, or other technical or policy criteria.

One basic source of misconception in the medical device industry is the technique the different national administrative frameworks use to recognize guidelines. This article clarifies the technique, beginning with models from the International Organization for Standardization (ISO) received and perceived in different administrative frameworks. The article utilizes ISO 13485:2003 and ISO 14971:2007 as delineations.

International Medical Device Standards

There are two associations that normally issue global models: the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

These guidelines are global norms, which means they apply to the world. Therefore, some random locale or nation could receive them, maybe with adjustments or impediments.

Universal benchmarks are indicated, normally, with three sections. First is the issuing association, second is a number, and the third is the time of issue. For instance, ISO 14971:2007 is a universal standard that ISO issued in 2007. The title is Medical gadgets — Application of hazard administration to medicinal gadgets.

Different precedents are:

• ISO 13485:2003, Medical gadgets — Quality administration frameworks — Requirements for administrative purposes
• ISO 10993-1:2009, Biological assessment of restorative gadgets — Part 1: Evaluation and testing inside a hazard administration process
• IEC 62366-1:2015, Medical gadgets — Part 1: Application of ease of use building to therapeutic gadgets

Once in a while, ISO will issue specialized reports identified with particular gauges. These are frequently considered direction records that assistance the peruser actualize the standard. For our essential models, ISO has issued ISO/TR 14969:2004, Medical gadgets — Quality administration frameworks — Guidance on the use of ISO 13485:2003, and ISO/TR 24971:2013, Medical gadgets — Guidance on the use of ISO 14971.

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