BS ISO 3749:2022 Glass Syringes. Determination of Extractable Tungsten

Standard Number: BS ISO 3749:2022

Pages: 20

Released: 2022-03-24

ISBN: 978 0 539 12757 7

Status: Standard

Overview

The BS ISO 3749:2022 standard is an essential document for professionals in the medical and pharmaceutical industries. This standard provides a comprehensive methodology for the determination of extractable tungsten in glass syringes. Tungsten is often used in the manufacturing process of glass syringes, and its presence can have significant implications for the safety and efficacy of medical treatments. Ensuring that the levels of extractable tungsten are within acceptable limits is crucial for maintaining the highest standards of patient care.

Key Features

• Comprehensive Methodology: The standard outlines a detailed and precise method for the determination of extractable tungsten, ensuring accurate and reliable results.
• Industry Relevance: Applicable to a wide range of medical and pharmaceutical applications, this standard is crucial for manufacturers, quality control laboratories, and regulatory bodies.
• Up-to-Date Information: Released on 2022-03-24, this standard reflects the latest advancements and best practices in the field.
• International Recognition: As an ISO standard, it is recognized and respected globally, facilitating international trade and compliance.

Why This Standard is Important

Glass syringes are widely used in the medical field for the administration of medications and vaccines. The presence of extractable tungsten can pose risks, including potential contamination and adverse reactions in patients. The BS ISO 3749:2022 standard provides a rigorous framework for testing and ensuring that glass syringes meet stringent safety criteria. By adhering to this standard, manufacturers can demonstrate their commitment to quality and patient safety, thereby enhancing their reputation and trustworthiness in the market.

Detailed Content

Spanning 20 pages, the BS ISO 3749:2022 standard is meticulously structured to cover all aspects of the determination of extractable tungsten. It includes:

• Introduction: An overview of the importance of testing for extractable tungsten in glass syringes.
• Scope: Defines the applicability of the standard and the types of glass syringes covered.
• Normative References: Lists other relevant standards and documents referenced within the standard.
• Terms and Definitions: Clarifies key terms used throughout the document.
• Test Method: Provides a step-by-step guide to the testing procedure, including sample preparation, equipment, and analytical techniques.
• Results and Interpretation: Guidelines for interpreting test results and determining compliance with acceptable limits.
• Annexes: Additional information and examples to support the main content.

Who Should Use This Standard?

The BS ISO 3749:2022 standard is indispensable for a variety of stakeholders in the medical and pharmaceutical industries, including:

• Manufacturers: Ensuring that their products meet the highest safety standards.
• Quality Control Laboratories: Conducting rigorous testing to verify compliance.
• Regulatory Bodies: Setting and enforcing safety standards for medical devices.
• Healthcare Providers: Understanding the safety and quality of the medical devices they use.

Conclusion

The BS ISO 3749:2022 standard is a vital resource for ensuring the safety and quality of glass syringes used in medical applications. By providing a detailed methodology for the determination of extractable tungsten, it helps manufacturers, quality control laboratories, and regulatory bodies maintain the highest standards of patient care. With its comprehensive content and international recognition, this standard is an essential tool for anyone involved in the production, testing, or regulation of glass syringes.

BS ISO 3749:2022

This standard BS ISO 3749:2022 Glass syringes. Determination of extractable tungsten is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters