624074/07 A-41
A.11 Standards and approvals
The HAMILTON-G5 was developed in accordance with perti-
nent international standards and FDA guidelines.
The ventilator is manufactured within an EN ISO 13485 and
EN ISO 9001, Council Directive 93/42/EEC, Annex II, Article 1
certified quality management system.
The ventilator meets the Essential Requirements of Council
Directive 93/42/EEC. It is a class IIb device.
The ventilator meets relevant parts of the following standards:
• IEC 60601-1: Medical electrical equipment, Part 1: General
requirements for safety. The device classification is: Class I,
Type B applied part (ventilator breathing system, VBS), type
BF applied part (CO
2
sensor including CO
2
module connec-
tor and SpO
2
sensor including SpO
2
adapter), ordinary
enclosed equipment without protection against ingress of
liquids, continuous operation
• IEC 60601-1-2: Medical electrical equipment: General
requirements for safety – Collateral standard: Electro-
magnetic compatibility. Requirements and tests
• IEC 60601-2-12: Medical electrical equipment: Particular
requirements for the safety of lung ventilators – Critical care
ventilators
• EN 794-1: Lung ventilators. Particular requirements for
critical care ventilators
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