What are the standards of a medical device?

What are the standards of a medical device?

The formal definition of a standard that should be adopted in the medical device domain is given by the ISO:

Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines or definitions of characteristics, to ensure that materials, products, process and services are fit for their purpose.

Types of specifications in standards

Standards can establish a wide range of specifications for products, processes and services (see www.iso.org for definitions).

1. Prescriptive specifications obligate product characteristics, e.g. device dimensions, biomaterials, test or calibration procedures, as well as definitions of terms and terminologies.

2. Design specifications set out the specific design or technical characteristics of a product, e.g. operating room facilities or medical gas systems.

3. Performance specifications ensure that a product meets a prescribed test, e.g. strength requirements, measurement accuracy, battery capacity, or maximum defibrillator energy.

4. Management specifications set out requirements for the processes and procedures companies put in place, e.g. quality systems for manufacturing or environmental management systems.

A standard may contain a combination of specifications. Prescriptive, design and performance specifications have been commonplace in standards. Management specifications are also rapidly gaining prominence.

Recent years have seen the development and application of what are known as “generic management system standards”, where “generic” means that the standards’ requirements can be applied to any organization, regardless of the product it makes or the service it delivers, and “management system” refers to what the organization does to manage its processes. Two of the most widely known series of generic management system standards are the ISO 9000 series for managing quality systems, and the ISO 14000 series for environmental management systems. Wide ranging information and assistance related to these standards and their application is available at www.iso.org. ISO 13485 and ISO 13488 are specific ISO quality systems standards for medical device manufacturing.

Terms such as outcome-oriented standards, objectives standards, function-focused standards and result-oriented standards are also employed. Essentially, these terms indicate that the standards specify the objectives (ends) to be achieved while leaving the methods (means) to the implementers. This can minimize possible constrictive effects of standards.

What are the standards of a medical device?

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