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en
3. Safety and Regulatory Information
- continued
3.
5
Statutory Requirements
• The Applanation Tonometer is designed as a Class
II
a device under the Medical
Device Directive 93/42/EEC.
• The Applanation Tonometer complies with the Tonometer regulation
ISO 8612:2009 & ISO 15004-1: 2006.
3.
6
Caution
• The safety regulations displayed in the operating instructions are to be
observed with special care.
Caution
Strictly observe all warning notices!
3.
7
Regulatory Information: CE-Mark
The products fulfil the requirements according to the following
standards:
Safety:
EN60601-1 Part 1: General Requirements for Safety,
Medical Electrical Equipment
Electrical:
EN60601-1-2 Part 2: Collateral Standard: Electromagnetic
Compatibility
Infrared:
EN60825-1 Part 1: Safety of Laser Products: Equipment
classification requirements