BS EN ISO 11197:2019

Comprehensive Healthcare Technology Standard

BS EN ISO 11197:2019 is the essential standard for healthcare technology professionals. This 46-page document provides detailed specifications and requirements to ensure the safety, performance, and compliance of medical equipment and systems.

Key Features and Benefits:

- Comprehensive coverage of healthcare technology design, manufacturing, and testing- Aligns with the latest ISO 11197 standard for medical supply units- Ensures patient and user safety through rigorous safety and performance criteria- Supports regulatory compliance for medical device manufacturers and healthcare providers- Applicable to a wide range of medical equipment, including: - Examination and treatment units - Surgical supply units - Anaesthesia workstations - Medical supply units

Detailed Technical Specifications

BS EN ISO 11197:2019 covers a broad range of technical requirements for healthcare technology, including:

Design and Construction

- General design principles- Mechanical safety requirements- Electrical safety and EMC considerations- Ergonomic design for user safety and comfort

Performance Testing

- Functional testing protocols- Measurement of key performance parameters- Validation of safety and reliability

Labeling and Documentation

- Comprehensive marking and labeling requirements- Detailed instructions for use and maintenance- Technical documentation for regulatory compliance

Ensure Compliance and Patient Safety

Adhering to the specifications outlined in BS EN ISO 11197:2019 is essential for healthcare technology manufacturers, suppliers, and users. By following this standard, you can:- Demonstrate compliance with the latest regulatory requirements- Ensure the safety and reliability of medical equipment and systems- Protect patients, healthcare workers, and the general public- Maintain the highest standards of quality and performanceWhether you're designing new medical devices, updating existing equipment, or managing a healthcare facility, BS EN ISO 11197:2019 is a critical resource for ensuring the safety and effectiveness of your healthcare technology.