BS EN ISO 7488:2018

Comprehensive Healthcare Technology Standard

BS EN ISO 7488:2018 is the essential standard for healthcare technology professionals. This British Standard, identical to ISO 7488:2018, provides detailed technical specifications and guidelines to ensure the safety, performance, and compliance of medical devices and equipment.

Ensure Regulatory Compliance

Adhering to BS EN ISO 7488:2018 is crucial for healthcare organizations to demonstrate compliance with relevant regulations and industry best practices. This standard covers a wide range of medical technologies, helping you navigate the complex regulatory landscape and mitigate risks.

Improve Patient Safety and Outcomes

By implementing the requirements outlined in BS EN ISO 7488:2018, you can enhance the safety and effectiveness of your medical devices and equipment. This standard focuses on critical aspects such as design, manufacturing, and maintenance, ensuring optimal performance and minimizing potential hazards to patients and healthcare professionals.

Key Features and Benefits

Comprehensive Technical Specifications

- Detailed requirements for the design, development, and production of medical devices and equipment- Guidelines for testing and validation to ensure safety and performance- Specifications for materials, components, and manufacturing processes

Alignment with Industry Standards

- Identical to ISO 7488:2018, ensuring global harmonization and recognition- Complements other relevant healthcare technology standards, such as ISO 13485 and IEC 60601

Risk Management and Quality Assurance

- Comprehensive risk assessment and mitigation strategies- Quality management system requirements for medical device manufacturers- Guidance on post-market surveillance and continuous improvement

Broad Applicability

- Covers a wide range of medical technologies, including diagnostic, therapeutic, and assistive devices- Applicable to both new product development and the maintenance of existing equipment

Ensure Compliance and Elevate Patient Care

By implementing the requirements of BS EN ISO 7488:2018, healthcare organizations can demonstrate their commitment to patient safety, regulatory compliance, and industry best practices. This standard is an invaluable resource for medical device manufacturers, healthcare providers, and regulatory authorities, helping to drive innovation and improve patient outcomes.