Statutory Requirements; Caution; Regulatory Information: Ce Mark - Haag-Streit Perkins Mk2 Manual De Instrucciones

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3. Safety and Regulatory Information
3.

Statutory Requirements

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• The Applanation Tonometer is designed as a Class IIa device under the Medical
Device Directive 93/42/EEC.
• The Applanation Tonometer complies with the Tonometer regulation
ISO 8612:2009 & ISO 15004-1: 2006.

Caution

3.
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• The safety regulations displayed in the operating instructions are to be
observed with special care.
Caution
Strictly observe all warning notices!
3. Regulatory Information: CE-Mark
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The products fulfil the requirements according to the following
standards:
Safety:
Electrical:
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EN60601-1 Part 1: General Requirements for Safety,
Medical Electrical Equipment
EN60601-1-2 Part 2: Collateral Standard: Electromagnetic
Compatibility
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