BS EN ISO 10555-6:2017+A1:2019 - Essential Standards for Healthcare Technology

The BS EN ISO 10555-6:2017+A1:2019 standard is a vital reference document within the framework of healthcare technology, focusing on the requirements for sterilized, single-use catheters and similar devices. This standard is particularly crucial for manufacturers, laboratories, and healthcare institutions involved in the production, testing, and application of these medical devices.

Scope and Purpose

This standard specifies the essential safety requirements for the design and manufacturing processes of catheters designed for single use. By adhering to these guidelines, manufacturers ensure compliance with international health and safety regulations, thereby guaranteeing the safety and effectiveness of the products they provide to healthcare professionals.

Key Features and Updates

The 2019 amendment (A1:2019) to the original ISO 10555-6:2015 reflects the latest advancements in healthcare technology and includes updates to the testing methods and performance criteria. Notable revisions aim to enhance the reliability and functionality of medical catheters, addressing both traditional applicability and emerging innovations in the field.

Compliance and Certification

Achieving compliance with the BS EN ISO 10555-6:2017+A1:2019 standard not only assists in meeting regulatory demands but also enhances product marketability. Certification to this standard is often a prerequisite for participation in healthcare markets across Europe and worldwide, enabling manufacturers to demonstrate their commitment to quality and safety.

Target Audience

The primary audience for this standard includes medical device manufacturers, quality assurance professionals, regulatory affairs specialists, and healthcare providers. It serves as both a guideline and a benchmark for ensuring that medical catheters meet stringent industry standards prior to being delivered for clinical use.

How to Access the Standard

The BS EN ISO 10555-6:2017+A1:2019 is available for purchase at a price of £220.00. It can be accessed in both PDF and hardcopy formats, making it convenient for various users, from engineers needing detailed specifications to healthcare facility managers requiring regulatory compliance documentation.

Conclusion

In a rapidly evolving medical landscape, staying updated with standards such as BS EN ISO 10555-6:2017+A1:2019 is crucial for ensuring patient safety and device efficacy. Investing in this standard assists organizations in maintaining high levels of health care technology quality while reinforcing their dedication to excellence and compliance.