A-1
A Product Specifications
A.1 Standards Compliance
The Anesthetic Vaporizer is in compliance with the following industry standards.
EN ISO 14971
/ISO 14971
Medical devices-Application of risk management to medical devices
EN 1041 Information supplied by the manufacturer with medical devices
EN
ISO15223-1/ISO15223-1
Medical devices-Symbols to be used with medical device labels, labeling
and information to be supplied
EN ISO 5360
/ISO 5360
Anaesthetic vaporizers - Agent-specific filling systems
EN 62366/IEC62366 Medical devices - Application of usability engineering to medical devices
/
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical
devices
EN 60601-1/IEC
60601-1
Medical electrical equipment -- Part 1: General requirements for basic
safety and essential performance
EN 60601-1-6:
Medical electrical equipment -- Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
EN 980 Symbols for use in the labelling of medical devices
ISO 80601-2-13
Medical electrical equipment --Part 2-13:Particular requirements for basic
safety and essential performance of an anaesthetic workstation
A.2 Physical Specifications
Weight 6 ± 0.5kg (empty)
Dimensions Height: 235 mm±10mm
Width: 235 mm±10mm
Depth: 200 ±10 mm
Filling volume 360 ml (dry wick)
300 ml (moist wick)
260 ml (between the minimum and maximum marks)
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