EN ISO 5360:2016
Current
The latest, up-to-date edition.
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
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 |
Standards | Relationship |
NEN EN ISO 5360 : 2016 | Identical |
NS EN ISO 5360 : 2016 | Identical |
NBN EN ISO 5360 : 2016 | Identical |
UNE-EN ISO 5360:2016 | Identical |
PN EN ISO 5360 : 2016 | Identical |
NF EN ISO 5360 : 2016 | Identical |
BS EN ISO 5360:2016 | Identical |
UNI EN ISO 5360:2016 | Identical |
ISO 5360:2016 | Identical |
SN EN ISO 5360:2016 | Identical |
SS-EN ISO 5360:2016 | Identical |
I.S. EN ISO 5360:2016 | Identical |
UNI EN ISO 5360 : 2012 | Identical |
DIN EN ISO 5360:2016-07 | Identical |
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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