BS EN ISO 5361:2023 - Anaesthetic and Respiratory Equipment: Tracheal Tubes and Connectors

Ensure the highest standards of safety and performance in your medical practice with the latest edition of the BS EN ISO 5361:2023. This comprehensive standard is essential for professionals involved in the design, manufacture, and use of anaesthetic and respiratory equipment, specifically tracheal tubes and connectors.

Key Features and Benefits

The BS EN ISO 5361:2023 standard provides detailed guidelines and specifications to ensure the quality and safety of tracheal tubes and connectors. Here are some of the key features and benefits:

• Comprehensive Coverage: Spanning 56 pages, this standard offers in-depth information and guidelines to ensure that all aspects of tracheal tubes and connectors are covered.
• Up-to-Date Information: Released on 2023-11-10, this is the most current standard, incorporating the latest advancements and best practices in the field.
• International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that your equipment meets international quality and safety benchmarks.
• ISBN: 978 0 539 29392 0 - Easily reference and order this standard using its unique ISBN number.

Why Choose BS EN ISO 5361:2023?

Adhering to the BS EN ISO 5361:2023 standard ensures that your tracheal tubes and connectors are manufactured to the highest quality, providing peace of mind for both healthcare providers and patients. Here are some reasons why this standard is indispensable:

Enhanced Patient Safety

Patient safety is paramount in any medical setting. This standard outlines stringent requirements for the design and performance of tracheal tubes and connectors, minimizing the risk of complications and ensuring optimal patient outcomes.

Regulatory Compliance

Compliance with international standards is often a prerequisite for regulatory approval. By adhering to BS EN ISO 5361:2023, you can streamline the approval process and ensure that your products meet the necessary regulatory requirements.

Quality Assurance

Implementing the guidelines and specifications outlined in this standard helps maintain consistent quality in the production of tracheal tubes and connectors. This consistency is crucial for building trust with healthcare providers and patients alike.

Global Market Access

As a globally recognized standard, BS EN ISO 5361:2023 facilitates access to international markets. Meeting this standard demonstrates your commitment to quality and safety, making your products more attractive to buyers worldwide.

Detailed Specifications

Standard Number	BS EN ISO 5361:2023
Pages	56
Released	2023-11-10
ISBN	978 0 539 29392 0
Name	Anaesthetic and respiratory equipment. Tracheal tubes and connectors
Status	Standard

Who Should Use This Standard?

The BS EN ISO 5361:2023 standard is designed for a wide range of professionals in the medical field, including:

• Medical Device Manufacturers: Ensure your products meet the highest standards of quality and safety.
• Healthcare Providers: Use equipment that complies with international standards to provide the best care for your patients.
• Regulatory Bodies: Reference this standard to evaluate the compliance of tracheal tubes and connectors.
• Quality Assurance Professionals: Implement the guidelines to maintain consistent quality in production.

Conclusion

In the ever-evolving field of medical technology, staying up-to-date with the latest standards is crucial. The BS EN ISO 5361:2023 standard is an invaluable resource for ensuring the safety, quality, and performance of tracheal tubes and connectors. By adhering to this standard, you can enhance patient safety, achieve regulatory compliance, and access global markets with confidence.

Don't compromise on quality. Invest in the BS EN ISO 5361:2023 standard today and ensure that your anaesthetic and respiratory equipment meets the highest international standards.

BS EN ISO 5361:2023

This standard BS EN ISO 5361:2023 Anaesthetic and respiratory equipment. Tracheal tubes and connectors is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications. Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document. NOTE 1      There is guidance or rationale for this clause contained in Annex A.2. NOTE 2      ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.