Standard-EN ISO-14971-for surgical disposables is the main standard application of risk management in the manufacture and use of medical devices. Essentially, it establishes the basic requirements for managing risk and determining the safety of medical devices by manufacturers all through the product design and development life cycle.
This activity is a requirement according to higher levels of regulation and other standards governing quality management systems. More specifically, ISO 14971 is in 9 parts, which work hand in hand to establish the framework for risk analysis, control, evaluation and management. It also specifies the procedure for reviewing and monitoring equipment during production and after production.
Today, EN ISO 14971:2012 is applied by manufacturers of medical devices made for the European market while ISO 14971:2007 is applied globally, and remains the recommended standard for the management of medical device risk.
Designing Single-Use Medical Devices
As mentioned above, Standard-EN ISO-14971 governs the balancing of user requirements, design specifications, cost targets, and various risk assessments.
When designing these single-use products, new engineers might only consider the cost. However, although disposable medical products are only used once, designing them requires that the manufacturer list and understand basic user requirements. The manufacturer should also balance performance, shelf life, materials, reliability, and cost.
To this end, Standard-EN ISO-14971-for surgical disposable ensures that the developers of medical devices and products develop an efficient and repeatable manufacturing proceed.
The End Use
Of course, user requirements have a profound influence on product specifications. However, when it comes to the manufacture of disposable products, more has to be considered.
Of course, cost is one of the significant of these factors since disposables are designed to be used only once. Today, technology has kept costs down and speeded up product development.
Still, Standard-EN ISO-14971-for surgical disposable has to be applied. This is why all devices are tested to ensure that they meet these strict international standards. They must also be found to work consistently and reliable.
By establishing this standard, designers are now forced to identify, recognize, and mitigate all risks associated with disposables. These risks include, but are not limited to:
a) The risk of design, which prevents all potential problems from the beginning of the product development process
b) Risk of process, which covers the product design and development, and covers management systems, methods, personnel, environment, equipment, machines, and materials used
c) Risk of use, which reviews all problems that might arise and how the design of the product can prevent such problems
In general, therefore, Standard-EN ISO-14971 ensures that manufacturers meet design requirements, gather as much information and data as possible, and liaise with different departments to come up with a structurally sound and safe product.
As such, it ensures that the following are applied:
- The right raw materials
- Appropriate assembly
- Clean rooms for automated assembly
- Veritable packaging and shipping
Overall, Standard-EN ISO-14971-for surgical disposables specifies the processes to be used in identified hazards commonly associated with medical devices, evaluate and estimate all associated risks, control such risks, and monitor the efficacy and efficiency of these controls. This is why the requirements of this standard have to be applied to each and every stage in the lifecycle of disposable medical devices. By implementing this standard, manufacturers are able to reign in risks and create products of a consistent quality.