What Components form a part of Non-Active Medical Devices under ISO 13485:2016 Certification?
ISO 13485:2016 for Medical Devices – Quality Management Systems (MD-QMS) is a globally known quality standard specifically designed for medical devices. Moreover, the International Organisation for Standardisation (ISO) first published this standard in 1996 and revised it in 2003 and 2016.
What is ISO 13485:2016 Certification?
ISO 13485 Certification outlines the framework for organisations to deliver high-quality medical devices to meet the needs and requirements of customers, clients, and stakeholders. The certification is significant for organisations involved in one or more stages of a medical device life-cycle, including design, development, production, storage, distribution, installation, and technical support.
MD-QMS applies to suppliers and external parties to deliver high-quality products and services to assure clients' and customers' well-being and safety.
Medical Devices are classified into two categories under ISO 13485:2016 Certification for Medical Devices – Quality Management Systems (MD-QMS). These are:
1. Active Medical Devices
2. Non-Active Medical Devices
Components of Active Medical Devices
An active medical device depends on a source of electrical energy or other sources for its operation. Moreover, it operates or acts by converting the available source of energy.
1.???? Detecting, diagnosing, screening, monitoring, investigation
1.???? Therapy
2.???? Recording patient images and anatomical models
3.???? Medical devices intended for contraception or prevention of sexually transmitted diseases
4.???? General rule for any other active medical device
领英推荐
Components of Non-Active Medical Devices
Non-Active Medical Devices form part of the Main Technical Areas under ISO 13485:2016 Certification. Moreover, Main Technical Areas are further classified into five categories; these are:
1. General Non-Active, Non-Implantable Medical Devices
Non-active medical devices are devices which do not depend on a source of energy to operate. Non-active medical devices are significant for healthcare, as they require rigorous testing to assure users' safety and intended functionality.
2. Non-Active Implants
Non-active implants include the following devices: non-active cardiovascular implants, non-active orthopaedic implants, non-active functional implants, and non-active soft tissue implants. Moreover, these implants do not stay in the human body for a lifetime.
3. Devices for Wound Care
Wound care medical devices help in wound dressing. Moreover, these include cotton wool, bandage, gauze dressing, sutures for dermal wound closures for less than 30 days, and surgical gloves. Wound care devices do not incorporate antimicrobial agents and do not utilise animal tissues.
4. Non-Active Dental Devices and Accessories
Non-active dental Devices and Accessories include all the non-active dental instruments and equipment, from X-ray cones to face bows. Moreover, it also includes dental materials and dental implants.
5. Non-Active Medical Devices other than Specified Above
Conclusion
ISO 13485:2016 certification defines additional requirements for healthcare and medical device industries to manage extra risks and hazards to the patient. However, the certification applies to the organisation and provides comprehensive quality management system guidelines for monitoring, maintaining, and controlling the processes and services.
Enjoy Reading -