BS EN ISO 10524-2:2019

Comprehensive Standard for Medical Gas Pressure Regulators

BS EN ISO 10524-2:2019 is the definitive standard for pressure regulators used in medical gas applications. This standard, which is identical to ISO 10524-2:2018, provides detailed requirements and test methods to ensure the safety, reliability, and performance of these critical components.

Ensuring Patient Safety and Regulatory Compliance

Medical gas pressure regulators play a vital role in healthcare, delivering the precise flow and pressure of gases such as oxygen, nitrogen, and medical air to patients. BS EN ISO 10524-2:2019 ensures that these regulators meet the highest standards of quality and safety, protecting both patients and healthcare professionals.

By adhering to this standard, manufacturers can demonstrate that their pressure regulators comply with the essential requirements of the Medical Devices Directive (93/42/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC), as well as the UK Medical Devices Regulations 2002. This helps to streamline the regulatory approval process and gives end-users confidence in the safety and reliability of the equipment.

Comprehensive Technical Specifications

• Detailed requirements for the design, construction, and performance of pressure regulators, including:
  • Materials and manufacturing processes
  • Pressure and flow rate specifications
  • Leak testing and pressure drop requirements
  • Resistance to contamination and ease of cleaning
• Test methods to verify compliance with the standard, including:
  • Mechanical tests (e.g., impact, vibration, and drop testing)
  • Functional tests (e.g., flow rate, pressure, and leakage measurements)
  • Environmental tests (e.g., temperature, humidity, and cleaning agent resistance)
• Marking and labeling requirements to ensure traceability and proper identification of the pressure regulator
• Guidance on the information to be provided by the manufacturer, including instructions for use, maintenance, and servicing

Ensuring Consistent Quality and Performance

By adhering to the requirements of BS EN ISO 10524-2:2019, manufacturers can ensure that their medical gas pressure regulators meet the highest standards of quality, safety, and performance. This helps to protect patients, healthcare workers, and the broader healthcare system by reducing the risk of equipment failure, gas leaks, or other potentially dangerous incidents.

For healthcare providers, specifying pressure regulators that comply with this standard can give them confidence in the reliability and safety of the equipment they use, ultimately contributing to better patient outcomes and a more efficient healthcare system.