BS EN ISO 5360:2016
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Anaesthetic vaporizers. Agent-specific filling systems
Published By | Publication Date | Number of Pages |
BSI | 2016 | 32 |
This International Standard specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.
This International Standard 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.
PDF Catalog
PDF Pages | PDF Title |
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4 | European foreword Endorsement notice |
5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Table ZA.1 — Correspondence between this European Standard and EU Directive 93/42/EEC |
8 | Foreword |
9 | 1 Scope 2 Normative references 3 Terms and definitions |
10 | 4 Bottle |
11 | 5 Bottle collar |
14 | 6 Bottle adaptor |
18 | 7 Filler receptacle |
20 | 8 Filling rate |
22 | 9 Leakage 10 Overfilling protection 11 Colour coding 12 Usability 13 Clinical evaluation |
23 | 14 Information provided by the manufacturer 14.1 Marking 14.2 Labelling 14.3 Instructions for use |
25 | Annex A (informative) Recommendations on materials |
26 | Annex B (informative) Types of agent-specific filling systems |
27 | Annex C (normative) Determination of total leakage into atmosphere of anaesthetic agent during filling |
29 | Bibliography |