BS ISO 15142-2:2003 - Comprehensive Overview

Explore the vital standards set forth in BS ISO 15142-2:2003, a key document for health care technology that establishes essential guidelines for the evaluation of medical devices and materials. This standard is a crucial reference for manufacturers, regulators, and healthcare professionals involved in the production and assessment of medical products.

Key Features

• Standard Number: BS ISO 15142-2:2003
• ISBN: 0 580 42496 0
• Price: £134.00
• Date of Publication: 2003-08-21
• Format: Available in both PDF and hardcopy

Technical Specifications

This British Standard is categorized under health care technology, specifically referenced as ISO 15142-2:2003. It outlines the framework for the assessment of product safety, effectiveness, and quality assurance processes necessary for medical technologies. The document plays a significant role in fostering standardization across the healthcare industry.

Objectives of the Standard

The primary objective of BS ISO 15142-2:2003 is to provide a structured approach to evaluating the performance and safety of healthcare devices and materials. By adhering to this standard, stakeholders can ensure that their products meet the rigorous requirements set forth by international benchmarks, facilitating market access and compliance with regulatory demands.

Importance for Stakeholders

Manufacturers will find this standard invaluable for aligning their product design and evaluation processes with international standards. Additionally, regulatory bodies can utilize these guidelines to establish comprehensive regulatory frameworks that safeguard patient health. The relevance of BS ISO 15142-2:2003 extends to healthcare professionals who depend on reliable medical products and technologies to deliver high-quality care.

Conclusion

Acquiring the BS ISO 15142-2:2003 standard represents a crucial step towards enhancing product quality and ensuring compliance within the highly regulated healthcare sector. By investing in this document, stakeholders can improve their operational procedures and contribute significantly to the safety and efficacy of medical devices and materials.