BS EN ISO 6717:2021 - In vitro Diagnostic Medical Devices

Single-use Containers for the Collection of Specimens from Humans Other Than Blood

Introducing the BS EN ISO 6717:2021, a comprehensive standard that sets the benchmark for in vitro diagnostic medical devices, specifically focusing on single-use containers designed for the collection of specimens from humans other than blood. This standard is essential for ensuring the highest quality and safety in the collection and handling of various human specimens, which is crucial for accurate diagnostic results.

Key Features and Benefits

• Standard Number: BS EN ISO 6717:2021
• Pages: 22
• Released: 2021-09-08
• ISBN: 978 0 539 14717 9
• Status: Standard

This standard is meticulously crafted to provide detailed guidelines and specifications for single-use containers used in the collection of human specimens other than blood. It ensures that these containers meet the highest standards of quality, safety, and reliability, which are critical for the integrity of diagnostic processes.

Why Choose BS EN ISO 6717:2021?

The BS EN ISO 6717:2021 standard is an indispensable resource for manufacturers, healthcare providers, and laboratories involved in the collection and analysis of human specimens. Here are some compelling reasons to adopt this standard:

1. Ensures High-Quality Specimen Collection

By adhering to the guidelines set forth in this standard, you can ensure that the single-use containers used for specimen collection are of the highest quality. This is crucial for maintaining the integrity of the specimens and obtaining accurate diagnostic results.

2. Enhances Patient Safety

Patient safety is paramount in any medical procedure. The BS EN ISO 6717:2021 standard ensures that the containers used for specimen collection are safe and reliable, minimizing the risk of contamination and ensuring the safety of both patients and healthcare providers.

3. Compliance with International Standards

This standard aligns with international guidelines, ensuring that your practices are in compliance with global standards. This is particularly important for organizations operating in multiple countries or those looking to expand their operations internationally.

4. Facilitates Regulatory Approval

Adhering to the BS EN ISO 6717:2021 standard can facilitate the regulatory approval process for your products. Regulatory bodies often require compliance with recognized standards, and this standard provides a clear framework for meeting those requirements.

5. Comprehensive and Detailed Guidelines

With 22 pages of detailed guidelines, the BS EN ISO 6717:2021 standard provides comprehensive information on the specifications and requirements for single-use containers. This ensures that you have all the information you need to produce and use these containers effectively.

Who Should Use This Standard?

The BS EN ISO 6717:2021 standard is designed for a wide range of stakeholders in the healthcare and diagnostic industries, including:

• Manufacturers of in vitro diagnostic medical devices
• Healthcare providers and institutions
• Clinical laboratories
• Regulatory bodies and compliance officers
• Quality assurance professionals

Conclusion

In the ever-evolving field of medical diagnostics, ensuring the quality and safety of specimen collection is of utmost importance. The BS EN ISO 6717:2021 standard provides a robust framework for the production and use of single-use containers for the collection of human specimens other than blood. By adopting this standard, you can enhance the quality of your diagnostic processes, ensure patient safety, and comply with international regulations.

Invest in the BS EN ISO 6717:2021 standard today and take a significant step towards excellence in medical diagnostics.

BS EN ISO 6717:2021

This standard BS EN ISO 6717:2021 In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood is classified in these ICS categories:

• 11.100 Laboratory medicine
• 11.100.10 In vitro diagnostic test systems
• 11.100.10 In vitro diagnostic test systems

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.

Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.

Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.

This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.