ISO 5360-2016 PDF

Full title and description

ISO 5360:2016 — Anaesthetic vaporizers — Agent-specific filling systems. International standard specifying requirements, dimensional details and safety-related characteristics for agent-specific filling systems used with anaesthetic vaporizers.

Abstract

ISO 5360:2016 defines the requirements, including dimensional specifications, for agent‑specific filling systems (bottles, bottle collars, bottle adaptors and filler receptacles) intended for use with agent‑specific anaesthetic vaporizers. The standard does not prescribe construction materials (recommendations appear in an informative annex). Because of the unique properties of desflurane, dimensions for that agent are not specified in this edition.

General information

• Status: Published (4th edition); reviewed and confirmed in a subsequent ISO review.
• Publication date: February 2016 (2016‑02).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 4 (2016).
• Number of pages: 21 pages (main text).

Scope

This International Standard specifies requirements, including dimensional specifications, for agent‑specific filling systems used with agent‑specific anaesthetic vaporizers. It covers the geometrical interface between containers (bottles and collars), bottle adaptors and the vaporizers’ filler receptacles to ensure agent specificity and reduce the risk of mis‑filling. The standard does not mandate particular construction materials; it includes guidance on materials and leakage considerations. Dimensions for desflurane bottles/adaptors are explicitly not specified because of that agent’s particular physical properties.

Key topics and requirements

• Dimensional requirements for bottles, bottle collars, bottle adaptors and filler receptacles to ensure agent‑specific connections.
• Design features that prevent engagement of an adaptor unless the bottle collar is correctly fitted (to reduce cross‑filling risk).
• Requirements and tolerances for mating interfaces and engagement mechanisms to ensure consistent, secure connections.
• Informative guidance on recommended materials and construction practices (materials not mandated by the standard).
• Provisions and guidance related to leakage during filling and measures to minimise atmospheric release.
• Exclusion of dimensional specifications for desflurane because of its unique properties; manufacturers must address this agent separately.

Typical use and users

Primary users include manufacturers and designers of anaesthetic vaporizers and associated filling equipment, medical device conformity and testing laboratories, hospital biomedical engineering and procurement teams, and regulatory bodies reviewing device safety and compatibility. The standard is used to design agent‑specific bottle/adaptor interfaces, to prepare technical documentation and to support conformity assessment and interoperability testing.

Related standards

Standards that are commonly used alongside ISO 5360 include other ISO/TC 121 documents covering anaesthetic and respiratory equipment (for example, standards for conical connectors and hose assemblies) and standards for anaesthetic workstations and device safety. Examples of related documents: ISO 5356 (conical connectors for anaesthetic and respiratory equipment), ISO 5359 (low‑pressure hose assemblies for medical gases) and standards for anaesthetic workstations and related medical electrical equipment.

Keywords

anaesthetic vaporizers, filling systems, agent-specific, bottle adaptor, bottle collar, filler receptacle, dimensions, leakage, desflurane, ISO/TC 121, medical devices, interoperability

FAQ

Q: What is this standard?

A: ISO 5360:2016 is an international standard titled "Anaesthetic vaporizers — Agent-specific filling systems" that specifies dimensional and other requirements for filling system interfaces used with agent‑specific anaesthetic vaporizers.

Q: What does it cover?

A: It covers requirements and dimensions for bottles, bottle collars, bottle adaptors and filler receptacles, design provisions to prevent incorrect engagement and guidance on leakage and recommended materials. It does not mandate construction materials and does not give dimensions for desflurane.

Q: Who typically uses it?

A: Manufacturers and designers of vaporizers and filling accessories, compliance and test laboratories, hospital biomedical engineering/procurement teams, and regulatory assessors use this standard to ensure safe and agent‑specific filling interfaces.

Q: Is it current or superseded?

A: This is the 2016 (4th) edition. It was reviewed and confirmed in a subsequent ISO review cycle and therefore remains the current edition unless superseded by a later ISO publication—users should check their national standards body for the absolute latest status before relying on it for regulatory decisions.

Q: Is it part of a series?

A: It forms part of ISO/TC 121’s body of standards on anaesthetic, respiratory and resuscitation equipment and is typically used together with related standards (e.g., those for connectors, hose assemblies and anaesthetic workstations).

Q: What are the key keywords?

A: Anaesthetic vaporizers, agent-specific filling systems, bottle adaptor, bottle collar, filler receptacle, desflurane, dimensions, leakage, medical device interoperability.