Canon CR-2 Deutschland, European Union

2 Safety

European Union

93/42/EEC	Medical Device Directive
EN 60601-1: 1990+A1: 1993+A2: 1995	Medical electrical equipment – Part 1: General
EN 60601-1: 2006	requirements for safety
IEC 60601-1-1: 2001	Medical electrical equipment – Part 1-1: General
	requirements for safety – Collateral standard: Safety
	requirements for medical electrical systems
EN 60601-1-2: 2007	Medical electrical equipment – Part 1-2: Collateral
	standard: Electromagnetic compatibility – Requirements
	and tests
IEC60601-1-4: 1996+A1: 1999	Medical electrical equipment – Part 1-4: General
	requirements for safety – Collateral standard:
	Programmable electrical medical systems
EN 60601-1-6: 2004	Medical electrical equipment – Part 1-6: General
	requirements for safety – Collateral standard: Usability
IEC 62304: 2006	Medical device software – Software life-cycle processes
EN 62366: 2008	Medical device – Application of usability engineering to
	medical devices
EN ISO 14971: 2009	Medical device – Application of risk management to
	medical devices
EN ISO 15004-1: 2009	Ophthalmic instruments – Part 1: General requirements
	applicable to all ophthalmic instruments
ISO 15004-2: 2007	Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009	Biological evaluation of medical devices – Evaluation and
EN ISO 10993-5: 2009	testing
EN ISO 10993-10: 2009

Deutschland

Während des Betriebs liegt der Schalldruckpegel dieses Instruments bei 70 dB(A) oder weniger gemäß EN ISO 7779.

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