Health Care Technology
Official British Standard
BS EN ISO 80601-2-67:2020
Comprehensive healthcare technology standard BS EN ISO 80601-2-67:2020. Ensures safety and performance of respiratory devices. Compliant with latest regulations.
## BS EN ISO 80601-2-67:2020 - Respiratory Therapy Equipment StandardThis British Standard, BS EN ISO 80601-2-67:2020, specifies the basic safety and essential performance requirements for respiratory therapy equipment. It is an identical adoption of the International Standard ISO 80601-2-67:2020.### Key Specifications:- Applies to electrically-powered respiratory therapy equipment- Covers a wide range of respiratory devices including ventilators, oxygen concentrators, and nebulizers- Ensures the safety and performance of these critical healthcare technologies- Aligns with the latest regulations and standards for medical devices### Compliance Benefits:- Demonstrates conformity with essential health and safety requirements- Reduces risk of patient harm through robust safety controls- Ensures respiratory devices meet stringent performance criteria- Facilitates market access and regulatory approval in the UK and EU### Technical Details:- Specifies general requirements for basic safety and essential performance- Covers aspects such as electrical safety, mechanical safety, and usability- Includes particular requirements for ventilatory support equipment- Provides test methods and acceptance criteria for verification and validationThis standard is a crucial reference for manufacturers, suppliers, and users of respiratory therapy equipment. It helps ensure these critical medical devices are designed, produced, and operated in a safe and effective manner, protecting both patients and healthcare professionals.By adhering to the specifications outlined in BS EN ISO 80601-2-67:2020, organizations can demonstrate compliance with the latest regulatory requirements and industry best practices. This supports the delivery of high-quality, reliable respiratory care, ultimately improving patient outcomes and healthcare system efficiency.Whether you are a manufacturer developing new respiratory devices or a healthcare provider procuring equipment, this British Standard is an essential resource for navigating the complex landscape of medical technology standards and regulations.
Technical Information
Health Care Technology
BSI Group
978 0 539 01162 3
Specification Details
- Medical electrical equipment - Particular requirements for basic safety and essential performance of oxygen-conserving equipment
Official BSI Standard
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