Health Care Technology Official British Standard

BS ISO 15674:2016+A1:2020

Comprehensive healthcare technology standard BS ISO 15674:2016+A1:2020. Ensure compliance and best practices for medical devices and systems. Detailed technical specifications.

Comprehensive Healthcare Technology Standard

BS ISO 15674:2016+A1:2020 is the essential standard for healthcare technology professionals. This British Standard, identical to the international ISO 15674 standard, provides detailed technical specifications and requirements for medical devices, systems, and related technologies.

Ensure Compliance and Best Practices

Compliance with BS ISO 15674 is crucial for any organization working in the healthcare technology sector. This standard outlines the necessary guidelines, processes, and quality controls to ensure the safety, reliability, and effectiveness of medical devices and systems. By adhering to this standard, you can demonstrate your commitment to industry best practices and regulatory compliance.

Detailed Technical Specifications

BS ISO 15674:2016+A1:2020 covers a wide range of technical requirements and specifications, including:- Design and development of medical devices and systems- Risk management and safety considerations- Validation and verification procedures- Labeling, packaging, and storage requirements- Maintenance, servicing, and decommissioning protocolsThe standard also addresses specific considerations for various healthcare technology applications, such as:- Diagnostic equipment- Therapeutic devices- Monitoring systems- Assistive technologies

Key Benefits of BS ISO 15674

- Ensures the safety and efficacy of medical devices and systems- Promotes best practices in healthcare technology development and deployment- Facilitates regulatory compliance and market access- Enhances the reliability and performance of healthcare technologies- Supports the continuous improvement of healthcare technology solutions

Stay Ahead of Industry Trends

By implementing BS ISO 15674:2016+A1:2020, you can demonstrate your organization's commitment to staying at the forefront of the healthcare technology industry. This standard reflects the latest advancements and best practices, helping you deliver innovative and reliable solutions that meet the evolving needs of healthcare professionals and patients.

Technical Information

Health Care Technology
BSI Group
978 0 580 51825 6
Specification Details
  • Cardiovascular implants and artificial organs
  • Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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