Health Care Technology Official British Standard

ASTM F2150 - 19

Discover ASTM F2150 - 19, a critical standard for evaluating healthcare technology performance. Ensure compliance and enhance safety in medical devices.

ASTM F2150 - 19: Comprehensive Guide for Healthcare Technology

The ASTM F2150 - 19 standard serves as an essential foundation for the health care technology sector, particularly focusing on the evaluation of performance requirements for medical devices. Published on October 1, 2019, this document addresses the need for consistent and reliable standards that ensure the safety and efficacy of healthcare products.

This standard is crucial for manufacturers, regulators, and healthcare professionals seeking to understand the benchmarks necessary for compliant medical device development and assessment. It covers a comprehensive range of criteria relevant to healthcare technologies, including aspects related to design, testing, and operational performance.

Under the Health Care Technology category, ASTM F2150 - 19 details methodologies that help stakeholders systematically analyze medical devices and their components. This standard guides users through the established protocols for testing and evaluating various attributes such as biocompatibility, safety, and user functionality.

Its applicability spans across a variety of medical devices—ranging from diagnostic tools to therapeutic instruments—making it a vital resource in ensuring that health care professionals have access to safe, reliable technologies. The adherence to ASTM F2150 - 19 not only enhances the quality of health care devices but also bolsters patient trust and regulatory compliance.

The format of the standard is available in both PDF and hardcopy, providing flexibility in how organizations choose to implement its guidelines. This accessibility ensures that information can be easily distributed and referenced within quality assurance departments and during regulatory inspections.

Purchasing the ASTM F2150 - 19 standard at the price of £74.00 is an investment in product safety and efficacy, reflecting a commitment to the highest standards in healthcare technology. By utilizing this standard, stakeholders can effectively navigate the complexities of medical device regulations and demonstrate compliance with industry best practices.

In summary, the ASTM F2150 - 19 is not just a regulatory requirement but a strategic asset that enhances quality assurance processes in the healthcare industry. With its detailed guidance on testing methodologies and performance evaluations, compliance with this standard positions organizations for success in the fast-evolving world of healthcare technology.

Technical Information

Health Care Technology
BSI Group
Specification Details
  • Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Official BSI Standard
Instant PDF Download
Industry Recognised

Purchase This Standard

Official Price
£74.00

Purchase the official standard directly from BSI Group. You'll be redirected to the official BSI website to complete your purchase.

Buy from BSI Group
Official BSI Standard
Instant PDF Download
Secure Payment