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EN ISO 5360:2016

Current

Current

The latest, up-to-date edition.

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

Published date

16-03-2016

European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Bottle
5 Bottle collar
6 Bottle adaptor
7 Filler receptacle
8 Filling rate
9 Leakage
10 Overfilling protection
11 Colour coding
12 Usability
13 Clinical evaluation
14 Information provided by the manufacturer
Annex A (informative) - Recommendations on materials
Annex B (informative) - Types of agent-specific filling systems
Annex C (normative) - Determination of total leakage into
        atmosphere of anaesthetic agent during filling
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices

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.

Committee
CEN/TC 215
DevelopmentNote
Supersedes EN 1280-1. (01/2008)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 1101:2017 Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out
BS 5252:1976 Framework for colour co-ordination for building purposes

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