BS EN ISO 8536-3:2009+A1:2022 Infusion Equipment for Medical Use Aluminium Caps for Infusion Bottles

Standard Number: BS EN ISO 8536-3:2009+A1:2022

Pages: 14

Released: 2022-09-14

ISBN: 978 0 539 17731 2

Name: Infusion Equipment for Medical Use Aluminium Caps for Infusion Bottles

Status: Standard

Overview

The BS EN ISO 8536-3:2009+A1:2022 standard is an essential document for professionals in the medical field, particularly those involved in the production and use of infusion equipment. This standard specifies the requirements for aluminium caps used in infusion bottles, ensuring that they meet the highest quality and safety standards.

Key Features

• Comprehensive Coverage: This standard covers all aspects of aluminium caps for infusion bottles, from design and materials to performance and safety requirements.
• Updated Information: The 2022 amendment (A1:2022) includes the latest updates and improvements, ensuring that the standard remains relevant and up-to-date.
• International Recognition: As an ISO standard, it is recognized and respected worldwide, making it a valuable resource for global medical equipment manufacturers and healthcare providers.
• Quality Assurance: Adhering to this standard helps ensure that aluminium caps for infusion bottles are of the highest quality, providing peace of mind to both manufacturers and end-users.

Detailed Description

The BS EN ISO 8536-3:2009+A1:2022 standard is a critical document for ensuring the safety and efficacy of infusion equipment used in medical settings. It provides detailed specifications for aluminium caps used in infusion bottles, covering aspects such as:

• Material Requirements: The standard specifies the types of aluminium and other materials that can be used, ensuring that they are safe and suitable for medical use.
• Design Specifications: Detailed design requirements are provided to ensure that the caps fit securely and function correctly with infusion bottles.
• Performance Criteria: The standard outlines the performance criteria that the caps must meet, including tests for durability, compatibility, and safety.
• Manufacturing Standards: Guidelines for the manufacturing process are included to ensure consistent quality and compliance with the standard.

Benefits of Compliance

Compliance with the BS EN ISO 8536-3:2009+A1:2022 standard offers numerous benefits, including:

• Enhanced Safety: By adhering to the stringent requirements of this standard, manufacturers can ensure that their products are safe for use in medical settings, reducing the risk of contamination and other issues.
• Improved Quality: The standard's detailed specifications help ensure that aluminium caps are of the highest quality, providing reliable performance and durability.
• Regulatory Compliance: Meeting the requirements of this internationally recognized standard can help manufacturers comply with regulatory requirements in various markets, facilitating global distribution.
• Customer Confidence: Compliance with this standard demonstrates a commitment to quality and safety, helping to build trust with healthcare providers and end-users.

Who Should Use This Standard?

The BS EN ISO 8536-3:2009+A1:2022 standard is designed for a wide range of professionals and organizations, including:

• Medical Equipment Manufacturers: Companies involved in the production of infusion equipment can use this standard to ensure that their products meet the highest quality and safety standards.
• Healthcare Providers: Hospitals, clinics, and other healthcare facilities can use this standard to evaluate the quality and safety of the infusion equipment they use.
• Regulatory Authorities: Government agencies and other regulatory bodies can use this standard as a benchmark for evaluating the safety and efficacy of infusion equipment.
• Quality Assurance Professionals: Individuals responsible for quality control and assurance in the medical equipment industry can use this standard to guide their processes and ensure compliance.

Conclusion

The BS EN ISO 8536-3:2009+A1:2022 standard is an invaluable resource for anyone involved in the production, use, or regulation of infusion equipment. By providing detailed specifications and guidelines for aluminium caps used in infusion bottles, this standard helps ensure the highest levels of quality and safety. Whether you are a manufacturer, healthcare provider, regulatory authority, or quality assurance professional, this standard is an essential tool for ensuring the safety and efficacy of infusion equipment.

BS EN ISO 8536-3:2009+A1:2022

This standard BS EN ISO 8536-3:2009+A1:2022 Infusion equipment for medical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment