BS EN ISO 17254:2016+A1:2021

Comprehensive Healthcare Technology Standard

BS EN ISO 17254:2016+A1:2021 is the essential standard for healthcare technology professionals. This standard provides detailed requirements and guidance for the design, development, and maintenance of medical devices and equipment. Compliance with this standard helps ensure the safety, effectiveness, and reliability of critical healthcare technologies.

Key Features and Benefits:

• Aligns with the latest ISO 17254 standard, including Amendment 1 updates• Covers a wide range of healthcare technology applications, from diagnostic tools to therapeutic devices• Provides a framework for risk management, quality assurance, and regulatory compliance• Helps organizations implement best practices for product lifecycle management• Supports the development of innovative, patient-centric medical technologies

Detailed Technical Specifications

BS EN ISO 17254:2016+A1:2021 specifies the requirements for the design, development, and maintenance of medical devices and equipment. The standard covers the following key areas:• Product Design and Development: - Requirements for design input, design output, and design verification/validation - Guidance on human factors engineering and usability - Considerations for software development and integration• Risk Management: - Processes for identifying, analyzing, and mitigating risks associated with medical technologies - Requirements for risk management planning and documentation• Quality Management: - Alignment with ISO 13485 quality management system requirements - Procedures for design and development control, process validation, and change management• Regulatory Compliance: - Conformance with relevant medical device regulations, such as the EU Medical Device Regulation (MDR) - Support for product registration, labeling, and post-market surveillance

Ensuring Compliance and Best Practices

By implementing the requirements of BS EN ISO 17254:2016+A1:2021, healthcare organizations can:• Develop safe, effective, and reliable medical devices and equipment• Demonstrate compliance with relevant regulations and standards• Improve product quality, reduce risks, and enhance patient outcomes• Streamline product development and lifecycle management processes• Foster innovation and competitiveness in the healthcare technology market

Get the Standard Today

Whether you're a medical device manufacturer, healthcare provider, or regulatory body, BS EN ISO 17254:2016+A1:2021 is a must-have resource for ensuring the safety and performance of critical healthcare technologies. Purchase the hardcopy or download the PDF version to access the latest requirements and guidance.