Graco 1750365 Owners Manual - Page 16

Applied standards and approvals

Page 16 highlights

Applied standards and approvals This product conforms to the provisions of the EC directive MDD(93/42/EEC). The following standards apply to design and/or manufacturing of the products: • ASTM E1965-98: Standard Specification for infrared thermometers for intermittent determination of patient temperature. • IEC/EN980:1997: Graphical symbol for use in the labeling of medical devices. • IEC/EN60601-1: Medical electrical equipment - Part 1: General requirement for safety. • IEC/EN60601-1-2: Medical electrical equipment - Part 2: Collateral standard: Electromagnetic compatibility - Requirements and tests. • ISO 14971 Risk Management 16

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16
This product conforms to the provisions of the EC
directive MDD(93/42/EEC).
The following standards apply to design and/or
manufacturing of the products:
• ASTM E1965-98:
Standard Specification for
infrared thermometers for intermittent
determination of patient temperature.
• IEC/EN980:1997:
Graphical symbol for use in
the labeling of medical devices.
• IEC/EN60601-1:
Medical electrical equipment
– Part 1:
General requirement for safety.
IEC/EN60601-1-2:
Medical electrical equipment
– Part 2:
Collateral standard:
Electromagnetic
compatibility – Requirements and tests.
• ISO 14971 Risk Management
Applied standards and approvals