Health Care Technology Official British Standard

BS ISO 16402:2008

Comprehensive healthcare technology standard BS ISO 16402:2008. Ensure compliance, quality, and safety with this essential industry guideline. Download or order the hardcopy today.

Comprehensive Healthcare Technology Standard

BS ISO 16402:2008 is a critical standard for the healthcare industry, providing essential guidance on the design, development, and implementation of healthcare technology. This standard, developed by the International Organization for Standardization (ISO), is a must-have resource for healthcare professionals, manufacturers, and regulators.

Key Features and Benefits

- Ensures quality, safety, and compliance in healthcare technology- Covers a wide range of healthcare technology, including medical devices, software, and systems- Provides a framework for risk management and quality assurance- Helps organizations meet regulatory requirements and industry best practices- Promotes interoperability and integration of healthcare technologies- Supports the development of innovative and reliable healthcare solutions

Comprehensive Guidance for Healthcare Technology

BS ISO 16402:2008 is a comprehensive standard that addresses the entire lifecycle of healthcare technology, from design and development to deployment and maintenance. The standard covers a wide range of topics, including:- Requirements and specifications for healthcare technology- Design and development processes- Quality management and risk assessment- Validation and verification procedures- Maintenance and service requirements- Regulatory compliance and industry standards

Ensuring Quality, Safety, and Compliance

Compliance with BS ISO 16402:2008 is essential for healthcare organizations and technology providers to ensure the quality, safety, and reliability of their products and services. By adhering to this standard, organizations can:- Reduce the risk of product failures or safety incidents- Demonstrate compliance with regulatory requirements and industry best practices- Improve the interoperability and integration of healthcare technologies- Enhance the overall quality and performance of healthcare solutions- Gain the trust and confidence of healthcare professionals and patients

Accessing the Standard

BS ISO 16402:2008 is available in both digital and hardcopy formats. The digital version can be downloaded immediately, while the hardcopy can be ordered for delivery. Regardless of the format, this standard is a critical resource for anyone involved in the healthcare technology industry.

Technical Information

Health Care Technology
BSI Group
978 0 580 60521 5
Specification Details
  • Implants for surgery
  • Acrylic resin cement
  • Flexural fatigue testing of acrylic resin cements used in orthopaedics
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