Overview
ISO 5362:2006 specifies safety, design and performance requirements for anaesthetic reservoir bags used with anaesthetic apparatus and lung‑ventilator breathing systems. The standard covers both antistatic and non‑antistatic bags, and applies to single‑use and reusable bags (within the manufacturer’s recommended product life). It excludes special‑purpose bellows, self‑expanding bags and scavenging system bags.
Key topics and technical requirements
- Scope & definitions: Defines terms such as plain neck, assembled neck, adaptor and tail; bag capacity is expressed in litres.
- Neck design:
- Plain necks must fit 22 mm male conical connectors (ISO 5356‑1); axial length ≥ 26 mm (unstretched).
- Assembled necks contain an adaptor with a female conical connector; attachments must resist separation (Annexes C and D).
- Capacity & size designation:
- Nominal capacity marked in litres; measured capacity must be within ±15% of nominal (Annex B).
- Leakage:
- Leakage limits at (3 ± 0.3) kPa: ≤ 10 ml/min for bags ≤ 1 L, ≤ 25 ml/min for bags > 1 L (Annex A).
- Distension (pressure/volume):
- Final pressure head when tested per Annex E must be 3.0–6.0 kPa.
- Bag must revert within 30 minutes to within ±10% of prior capacity after distension.
- Electrostatic control:
- Antistatic bags must meet IEC 60601‑1:1988 (39.3b); black bags are required to be antistatic.
- Sterility & packaging:
- “STERILE” bags must meet EN 556 and be packaged per ISO 11607‑1.
- Marking & information:
- Reusable and single‑use markings: manufacturer, nominal capacity, “ANTISTATIC” if for flammable agents, and “SINGLE USE” if applicable. Latex presence must be indicated.
- Manufacturers must provide cleaning/sterilization instructions and maximum reuses for reusable bags.
Practical applications
- Use ISO 5362 to develop technical specifications for manufacturing and quality control of reservoir bags (capacity testing, leakage testing, neck attachment tests, pressure/volume tests).
- Ensure safe selection of reservoir bags for operating theatres where flammable anaesthetics are used (antistatic requirements).
- Provide procurement criteria and labeling requirements for hospitals, distributors and clinical engineers.
- Support regulatory documentation and CE/market compliance for medical device manufacturers.
Who uses this standard
- Medical device manufacturers (design, R&D, QA)
- Clinical biomedical engineers and procurement teams
- Regulatory affairs and compliance professionals
- Hospital clinicians and anesthesiologists specifying equipment
Related standards
Keywords: ISO 5362, anaesthetic reservoir bags, antistatic, single‑use, reusable, leakage, capacity, pressure/volume, medical device standard.