EN ISO 5360:2016 PDF

Name: EN ISO 5360:2016 — Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
SKU: EN ISO 5360:2016
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Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)

Название (английский):

EN ISO 5360:2016

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 30
Дата публикации:: 16 марта 2016 г.
Издание:: CEN EN 5360 edition 2 version 1
ICS:: 11.040.10

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Описание (английский):

ISO 5360:2016 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers. ISO 5360:2016 does not specify construction materials. NOTE 1 For recommendations on materials, see Annex A. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard. NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.

Abstract

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Стандарты, упомянутые в описании

Overview

EN ISO 5360:2016 (ISO 5360:2016) - "Anaesthetic vaporizers - Agent-specific filling systems" is a CEN-adopted international standard that specifies requirements, including dimensions, for agent-specific filling systems used with anaesthetic vaporizers. The document covers the functional interfaces between liquid anaesthetic bottles and vaporizers to ensure safe, specific, and leak-minimised connections. The standard does not prescribe construction materials (see Annex A for material recommendations). Because of the unique properties of desflurane, dimensions for that agent are intentionally omitted.

Key topics

Agent-specific design: Defined configurations and dimensional requirements so only the correct anaesthetic agent connects to a given vaporizer.

Parts and interfaces: Requirements for bottles, bottle collars, bottle connectors, bottle adaptors, male adaptors and filler receptacles.

Performance criteria: Tests and limits for filling rate, leakage to atmosphere, and overfilling protection.

Safety and usability: Colour coding, labelling, marking, instructions for use, and usability considerations to reduce user error.

Clinical and regulatory elements: Requirements for clinical evaluation and manufacturer information (marking, labelling, instructions).

Annexes:

Annex A - recommendations on materials (informative)
Annex B - types of agent-specific filling systems (informative)
Annex C - method to determine total leakage into atmosphere during filling (normative)

Normative reference: ISO 1101 (geometrical tolerancing) is referenced for form and tolerance requirements.

Practical applications

Manufacturers of anaesthetic vaporizers, liquid anaesthetic bottles, and bottle adaptors use EN ISO 5360:2016 to design agent‑specific connectors that prevent cross‑contamination and accidental use of the wrong agent.

Medical device designers and quality engineers apply the dimensional and leakage requirements to achieve conformity and safe device interoperability.

Hospital procurement, biomedical engineers, and clinical safety officers use the standard to verify compatibility, labelling, and safe filling practices.

Regulators and conformity assessment bodies reference the standard for demonstrating compliance with medical device directives (see informative Annex ZA relating to EU Directive 93/42/EEC).

Related standards

ISO 1101 - Geometrical product specifications (GPS): tolerancing (normative reference)

EN ISO 5360:2016 is the European adoption of ISO 5360:2016 and supersedes earlier editions (EN ISO 5360:2012).

Keywords: EN ISO 5360, ISO 5360:2016, anaesthetic vaporizers, agent-specific filling systems, desflurane, medical device standards, filling rate, leakage, bottle adaptor, CEN.

EN ISO 5360:2016 PDF

Abstract

Похожие стандарты

Overview

Key topics

Practical applications

Related standards

Технические детали

ISO 5360:2016

Anaesthetic vaporizers — Agent-specific filling systems

ISO 5360:2012

Anaesthetic vaporizers — Agent-specific filling systems

SIST EN ISO 1101:2017

Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, locatio…

SIST EN ISO 5360:2016

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)