Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices.
This makes it more prescriptive in nature and requires a more thoroughly documented QMS. Therefore, ISO 13485 includes particular requirements for organisations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance. ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. ISO 13485 requires organisations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in. Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. The EnviteC Medical Oxygen Sensors are intended as oxygen sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures in the following applications: Sensing device for oxygen in medical ventilators, anesthesia machines, incubators, and control device of oxygen concentrators.EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This innovation was driven by European regulations to fulfill RoHS regulatory requirements for medical applications. Honeywell lead-free O2 sensors are a one-to-one, drop-in replacement - no application redesign needed. Step into the lead-free future: With innovative technology and engineering expertise, Honeywell has developed a patent-pending, lead-free oxygen sensor series. EnviteC designs customized sensors characterized by a high degree of precision, for example with different signal levels or temperature compensation elements.
This input is used for different standard and OEM applications, and ongoing support is provided right up to the final integration in the solution. EnviteC Cross Reference List | Tech Supportįrom standard sensors to customized sensors: Experienced EnviteC engineers analyze customer requirements.
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