ISO 15001:2010 – The Global Standard for Oxygen Compatibility in Medical Devices
ISO 15001 is an international standard that specifies requirements for the oxygen compatibility of materials, components, and equipment used in anaesthetic and respiratory systems. It ensures that products coming into contact with pressurized
oxygen are safe, non-reactive, and reliable in both normal operation and single-fault conditions.
Obtaining ISO 15001 certification through LEADMAX demonstrates your organization’s dedication to delivering safe, compliant, and high-quality medical devices used in oxygen-rich environments.
Our certification process ensures full compliance with ISO 15001 requirements and relevant local health and safety regulations. LEADMAX supports clients across the UAE (Dubai, Sharjah, Abu Dhabi), Saudi Arabia, Qatar, Oman, Kuwait, India, and other parts of Asia, Europe, and the Middle East.
LEADMAX providing the certification across the Middle East and Asia, offering ISO 15001 services in UAE, India, Qatar, Oman, Bahrain, and more. We specialize in oxygen compatibility certification for manufacturers, hospitals, and system integrators involved in anaesthetic and respiratory equipment.
Organizations in Dubai, Abu Dhabi, Sharjah, or other GCC countries can contact LEADMAX for a ISO 15001 roadmap. We assist with gap analysis, technical documentation, cleanliness protocols, and oxygen ignition risk assessments to meet all international and local regulatory expectations.
LEADMAX offers comprehensive ISO 15001 certification services across Europe and Asia. Our regionally experienced auditors and consultants assist with regulatory alignment, oxygen compatibility assessments, and documentation support, ensuring your devices meet both EU MDR and international compliance standards for oxygen-enriched environments.