Overview
ISO 18835:2015 - "Inhalational anaesthesia systems - Draw-over anaesthetic systems" specifies basic safety and essential performance requirements for anaesthetic systems that use the draw-over method to deliver inhalational anaesthesia. The standard covers systems designed to operate without compressed gas or electricity and includes provisions for use with both non‑flammable and flammable anaesthetic agents. It also contains requirements for a bellows‑type manual ventilator. Note that monitoring of patient parameters and automatic anaesthetic ventilators are outside its scope.
Key topics and technical requirements
- Scope and risk management
- Manufacturers must follow a risk management process in accordance with ISO 14971 and mitigate unacceptable risks by design, protection, monitoring/alarms, or labelling.
- Construction and components
- Defines required components: draw‑over vaporizer, breathing system, optional reservoir and bellows‑type manual ventilator for oxygen supplementation.
- Addresses ports, connectors, operator‑detachable parts and marking of operator‑assembled components.
- Performance
- Sets performance limits for breathing resistance (example limits included: inspiration ≤ 0.6 kPa, expiration ≤ 0.2 kPa under specified conditions).
- Specifies requirements for materials, mechanical hazards, particulate protection and environmental resistance.
- Compatibility with agents
- Requirements permit the use of both flammable and non‑flammable anaesthetic agents, with specific construction and materials guidance to ensure safety.
- Documentation and marking
- Details manufacturer information, labelling, instructions for use and packaging requirements.
- Supporting annexes
- Annex A: rationale for selected requirements; Annex B: normative test methods; Annex C: environmental aspects; Annex D: reference to essential principles.
Practical applications - who uses ISO 18835:2015
- Medical device manufacturers designing or certifying draw‑over vaporizers, breathing systems, reservoirs and manual ventilators.
- Regulatory bodies and notified bodies assessing conformity and safety claims.
- Procurement teams and NGOs specifying equipment for low‑resource or field settings where compressed gas and electricity may be unavailable.
- Biomedical engineers and clinical engineers responsible for maintenance, inspection and integration of draw‑over systems.
- Clinicians and anesthetists seeking to understand equipment limits and safe use scenarios (note: patient monitoring standards are not included).
Related standards
Keywords: ISO 18835:2015, draw‑over anaesthetic systems, inhalational anaesthesia, draw‑over vaporizer, bellows‑type manual ventilator, low‑resource settings, medical device safety.