DIN EN ISO 5360 E 2015-07 PDF

Full title and description

STB DIN EN ISO 5360 E 2015-07 — Anaesthetic vaporizers — Agent-specific filling systems. English and German version published as the FprEN/EN draft (designation E) on 01 July 2015; later incorporated into the formal EN/ISO edition published in 2016.

Abstract

This document specifies requirements, including dimensions, for agent-specific filling systems used with agent-specific anaesthetic vaporizers. It defines the components of filling systems (bottle neck and collar, bottle connector, bottle adaptor, filler receptacle, male/female adaptors), their intended non-interchangeable / coded nature for safety, and recommendations on marking and compatibility. The standard does not prescribe construction materials (recommendations appear in an annex) and excludes dimensional specification for desflurane because of its unique properties.

General information

• Status: Withdrawn / Draft (FprEN) version from 01 July 2015; superseded by the EN ISO 5360:2016 final edition.
• Publication date: 01 July 2015 (designation E — FprEN / English-German draft).
• Publisher: DIN / CEN (German-language and English-language release as the FprEN version of EN ISO 5360).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: FprEN / E version (2015-07) — draft English/German version later formalized as EN ISO 5360:2016.
• Number of pages: Listed as 59 pages in catalog listings for the 2015-07 FprEN release (page counts vary between national reproductions and the later 2016 EN/ISO publication).

Scope

The draft standard covers the design and dimensional requirements for agent-specific filling systems that connect bottles of liquid anaesthetic agents to vaporizers so that only the correct agent can be filled into a matching vaporizer. It is intended to enhance patient safety by preventing misfilling and cross-contamination between different anaesthetic agents. The document sets out functional definitions, component descriptions, dimensional interfaces, and labelling/identification requirements; it does not mandate construction materials. Desflurane is explicitly excluded from dimensional specifications because of its particular properties.

Key topics and requirements

• Definitions of agent-specific filling system components (bottle neck and collar, bottle connector, bottle adaptor, filler receptacle, male/female adaptors).
• Dimensional specifications and tolerances for interconnecting parts to ensure agent-specific (non-interchangeable) fit.
• Requirements and recommendations for marking, coding and identification to avoid inadvertent use of the wrong agent.
• Design guidance to prevent leakage and ensure safe connection/disconnection procedures.
• Notes and annex material on recommended materials and on special cases (e.g., desflurane omitted from dimensional specification).
• Reference to test/acceptance checks for mechanical fit and functional compatibility where applicable.

Typical use and users

Primary users are medical device manufacturers (vaporizers, bottle adaptors and connectors), design and product engineers in anaesthesia equipment, conformity assessment and testing laboratories, hospital biomedical engineering and procurement teams, and regulators reviewing device interoperability and safety. The standard is used during product design, supplier verification, acceptance testing, and clinical procurement specifications.

Related standards

Related and cross-referenced standards include earlier editions of EN ISO 5360 (e.g., EN ISO 5360:2012), and other medical gas/connector standards (for example the ISO/CEN standards on respiratory/anaesthesia connectors and fittings). The FprEN/EN process for this item led to EN ISO 5360:2016 as the formal published edition.

Keywords

anaesthetic vaporizers, filling systems, agent-specific, bottle adaptor, bottle connector, bottle collar, non‑interchangeable connections, desflurane exception, medical device, EN ISO 5360.

FAQ

Q: What is this standard?

A: It is the FprEN / English-German draft designation E of DIN EN ISO 5360 published 01 July 2015 (STB DIN EN ISO 5360 E 2015-07), covering agent-specific filling systems for anaesthetic vaporizers; this draft was taken forward into the formal EN/ISO edition published in 2016.

Q: What does it cover?

A: It defines the components, dimensional interfaces and safety/identification requirements for agent-specific filling systems so that anaesthetic agents can only be filled into the correct, matching vaporizer. The draft does not specify construction materials and excludes desflurane from dimensional specification.

Q: Who typically uses it?

A: Manufacturers of vaporizers and filling-system components, medical device design engineers, testing laboratories, hospital biomedical engineers, and regulatory/compliance teams.

Q: Is it current or superseded?

A: The E (FprEN) version dated 01 July 2015 is a draft/early (published) stage; it was superseded by the formal EN/ISO publication (EN ISO 5360:2016). Users should refer to the 2016 EN/ISO edition for the finalized requirements.

Q: Is it part of a series?

A: It sits within the family of standards for anaesthesia and respiratory equipment (ICS 11.040.10) and is related to other connector and gas-connection standards; it replaces/updates previous EN ISO 5360 editions and is identified in CEN/DIN product histories.

Q: What are the key keywords?

A: Anaesthetic vaporizers, agent-specific filling system, bottle adaptor, bottle connector, bottle collar, non‑interchangeable connections, desflurane.