Health Care Technology Official British Standard

BS EN ISO 13397-3:1997

Purchase BS EN ISO 13397-3:1997. A key healthcare technology standard ensuring safety and efficacy in medical devices. Available in PDF or hardcopy.

Product Overview: BS EN ISO 13397-3:1997

BS EN ISO 13397-3:1997 is an essential standard designed to enhance safety and functionality within health care technology. Published on April 15, 1997, this comprehensive document serves as a vital reference point for professionals involved in the design, assessment, and application of medical devices.

Key Features and Specifications

  • Standard Number: BS EN ISO 13397-3:1997
  • ISBN: 0 580 26681 8
  • Price: £158.00
  • Publication Date: April 15, 1997
  • Format: Available in both PDF and hardcopy
  • Sector: Health Care Technology

Importance of the Standard

This standard is primarily focused on establishing criteria for the performance of healthcare technology products and systems, ensuring they meet rigorous safety, reliability, and effectiveness standards. By adhering to these specifications, manufacturers can ensure their products contribute to enhanced patient care and reduced risks associated with medical interventions.

Who Should Utilize This Standard?

BS EN ISO 13397-3:1997 is designed for a range of stakeholders within the healthcare sector, including:

  • Medical device manufacturers seeking to comply with European regulations
  • Healthcare professionals aiming to understand the operational standards of medical technologies
  • Quality assurance teams responsible for product validation and compliance
  • Regulatory bodies tasked with enforcing safety and efficacy standards

Benefits of Compliance

Adherence to BS EN ISO 13397-3 not only demonstrates commitment to quality but also increases market acceptance and customer trust. Compliance can significantly mitigate the risks associated with product recalls, legal liability, and potential health hazards, ultimately leading to better outcomes for patients. Furthermore, this standard facilitates international trade by aligning product specifications with European norms, promoting broader market access for compliant devices.

Ordering Information

BS EN ISO 13397-3:1997 is available for immediate purchase at £158.00. Interested parties can choose between a PDF format for digital accessibility or a hardcopy for traditional reference. Ensure your healthcare technology practices align with the best in industry standards by acquiring this vital document today.

Technical Information

Health Care Technology
BSI Group
0 580 26681 8
Specification Details
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