BS EN ISO 8836:2020

Comprehensive Standard for Healthcare Suction Catheters

BS EN ISO 8836:2020 is the essential standard for healthcare suction catheters. This British Standard, identical to ISO 8836:2019, provides detailed technical specifications and testing requirements to ensure the safety, quality, and compliance of these critical medical devices.

Ensuring Patient Safety and Effective Suction

Suction catheters play a vital role in healthcare, enabling the removal of secretions, mucus, and other fluids from a patient's airway or other body cavities. BS EN ISO 8836:2020 sets out stringent requirements to guarantee the performance and safety of these devices, including:- Dimensions and design characteristics to optimize suction efficiency and patient comfort- Strength and flexibility testing to prevent breakage or damage during use- Biocompatibility and sterilization requirements to minimize infection risk- Labeling and packaging specifications for clear identification and sterile delivery

Comprehensive Technical Specifications

This standard covers a wide range of technical details to ensure suction catheters meet the highest quality and safety standards, such as:- Materials and construction, including permissible components and manufacturing processes- Dimensional tolerances for critical features like tip shape, suction eyes, and connector size- Mechanical testing procedures for tensile strength, flexibility, and resistance to kinking- Sterilization methods and validation, including requirements for sterile barrier systems- Labeling content and placement, including symbols, warnings, and traceability information

Demonstrating Compliance and Regulatory Approval

Conformance to BS EN ISO 8836:2020 is essential for healthcare providers, manufacturers, and suppliers to demonstrate that their suction catheters meet stringent international standards. This standard is harmonized with relevant EU medical device regulations, allowing manufacturers to affix the CE marking and access the European market.Additionally, BS EN ISO 8836:2020 is widely recognized and referenced by regulatory bodies worldwide, facilitating global market access and acceptance of these critical medical devices.

Comprehensive Guidance for Healthcare Professionals

Beyond the technical specifications, BS EN ISO 8836:2020 also provides valuable guidance for healthcare professionals on the proper selection, use, and maintenance of suction catheters. This includes recommendations on:- Catheter size selection based on patient anatomy and clinical needs- Techniques for safe and effective suction procedures- Proper handling, storage, and disposal of suction catheters- Monitoring and maintenance to ensure ongoing performance and safetyBy adhering to the requirements of BS EN ISO 8836:2020, healthcare organizations can be confident in the quality and safety of the suction catheters they use, ultimately improving patient outcomes and reducing the risk of complications.