BS EN ISO 9363-1:1999
Discover BS EN ISO 9363-1:1999, a key standard for healthcare technology, providing guidelines for accurate measurement and identification in medical devices.
BS EN ISO 9363-1:1999 - Comprehensive Guide to Technical Specifications
The BS EN ISO 9363-1:1999 standard is an essential document that sets forth the specifications for the identification and nomenclature of measurable variables and characteristics in the healthcare technology sector. Released on 15th December 1999, this standard is an identical adoption of ISO 9363-1:1994, ensuring consistency and reliability within health technology evaluation and measurement practices.
Purpose and Scope: The principal aim of this standard is to provide clear guidelines that facilitate the effective identification of medical devices and health technologies based on their measured variables. This promotes not only interoperability within systems but also enhances the comparability of health outcomes across different devices and settings. By adhering to the specifications outlined within this document, medical professionals and manufacturers can better ensure the efficiency, safety, and efficacy of their technologies.
This standard plays a pivotal role in aligning healthcare technology with modern challenges, including regulatory compliance and international harmonization. It serves as a guide for manufacturers, developers, and health professionals who seek to standardize their measurement methodologies and improve data integrity in clinical evaluations.
Key Features:
- Identical to ISO 9363-1:1994: Offers a cohesive framework consistent with international standards, promoting global collaboration.
- Focus on Measurable Variables: Emphasizes critical metrics that affect device deployment and patient outcomes.
- Enhanced Safety and Efficacy: Supports best practices that lead to improved clinical results and patient satisfaction.
As the landscape of healthcare technology evolves, adherence to standards like BS EN ISO 9363-1:1999 is crucial for maintaining high-quality practices within the industry. The document is available in hardcopy format and can be acquired for £134.00, making it a valuable investment for institutions committed to upholding exemplary health standards.
Ultimately, the implementation of this standard is indispensable for healthcare organizations aiming to navigate the complexities of modern medical technology, ensuring that they remain compliant with both local and international legislation. By integrating the principles outlined in BS EN ISO 9363-1:1999 into their operational frameworks, organizations can significantly enhance their service delivery while safeguarding patient welfare.
For detailed insights and to obtain your copy of this vital standard, visit the official standards organization site today.
Technical Information
Specification Details
- Optics and optical instruments
- Contact lenses
- Determination of cytotoxicity of contact lens material - Agar overlay test and growth inhibition test