BS ISO 12771:1997 - Medical Device Safety Standards

The BS ISO 12771:1997 standard is a critical document in the field of health care technology, published on September 15, 1997. This British Standard aligns with the international guidelines outlined by ISO 12771:1997, ensuring that medical devices, particularly those focused on in-vitro diagnostics, meet the necessary safety and performance requirements.

Healthcare practitioners and manufacturers must adhere to this comprehensive standard to foster safety and efficacy in medical device operations. The BS ISO 12771:1997 provides a framework for assessing and managing the risks associated with medical devices, thereby safeguarding patient health while enhancing the reliability of medical services. This standard facilitates a collaborative approach between manufacturers and healthcare providers in achieving compliance with safety protocols and international best practices.

Key aspects of BS ISO 12771:1997 include:

• Risk Management: Establishes processes for identifying potential hazards, evaluating risks, and implementing effective control measures.
• Documentation: Specifies comprehensive documentation requirements that ensure transparency and traceability in the development and usage of medical devices.
• Testing Protocols: Outlines the testing frameworks and methodologies necessary for verifying device safety and performance.
• Regulatory Compliance: Provides guidelines for compliance with existing regulatory frameworks, which is essential for market access and acceptance.

Purchasing BS ISO 12771:1997 at a price of £134.00 grants you access to an in-depth resource that is indispensable for stakeholders in the medical technology field. Available in both PDF and hardcopy formats, the standard is easily accessible for reference and application in various health care settings.

Adopting the guidelines set forth in BS ISO 12771:1997 not only aligns organizations with leading international standards but also enhances their reputation as trusted providers of safe and effective medical solutions. Ensure your products meet the highest standards of quality and safety by implementing the principles laid out in this essential standard.