BS EN ISO 80601-2-12:2020

## BS EN ISO 80601-2-12:2020 - Medical Ventilators for Critical CareBS EN ISO 80601-2-12:2020 is the essential standard for manufacturers of medical ventilators used in critical care settings. This British Standard, identical to ISO 80601-2-12:2020, specifies the safety and performance requirements for ventilatory equipment intended for use in the respiratory care of patients.### Key Specifications- Applies to ventilators for use in critical care, including those used for anaesthesia- Covers basic safety and essential performance requirements- Includes testing methods to verify compliance with the standard- Harmonized with the Medical Devices Directive 93/42/EEC and the In Vitro Diagnostic Medical Devices Directive 98/79/EC### Benefits of Compliance**Ensure Patient Safety**- Comprehensive safety requirements minimize risks to patients under ventilatory support- Testing methods validate the ventilator's ability to deliver accurate, reliable respiratory therapy**Meet Regulatory Requirements**- Compliance with BS EN ISO 80601-2-12:2020 aids in meeting the essential requirements of EU medical device regulations- Demonstrates conformity for CE marking and access to the European market**Improve Device Performance**- Specifications cover essential performance characteristics such as volume delivery, pressure, and oxygen concentration- Verification testing helps optimize ventilator functionality and reliability**Streamline Development**- Provides a unified set of requirements, reducing time and costs associated with product development and testing- Harmonized with other relevant medical device standards for a comprehensive compliance framework### Who Needs This Standard?BS EN ISO 80601-2-12:2020 is an essential reference for any organization involved in the manufacture, supply, or use of medical ventilators for critical care applications, including:- Ventilator manufacturers- Medical device suppliers and distributors- Hospitals and healthcare facilities- Regulatory bodies and testing laboratoriesEnsure your critical care ventilators meet the latest safety and performance requirements by obtaining a copy of BS EN ISO 80601-2-12:2020 today.