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10. General Guidelines and Notes
EC Directives
1. Directive 98/79/EC on in-vitro diagnostic devices
EN / ISO standards
2. EN ISO 9001:1994, Quality Management Systems, Model for quality
assurance in design, development, production, installation and customer
service
3. EN ISO 13485, Medical devices, Requirements for regulatory purposes
(application of EN ISO 9001)
4. EN ISO 14971, Medical devices - Application of risk management to
medical devices
5. EN 61010 -1, Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 1: General requirements
6. EN 61010 -2-101, Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 2-101: Particular
requirements for in-vitro diagnostic (IVD) medical equipment
7. EN 61326 -1, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 1: General requirements
8. EN 61326 -2-6, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 2-6: Particular requirements –
In-vitro diagnostic (IVD) medical equipment
9. EN 592, Instructions for use for in-vitro diagnostic instruments for
professional use
National directives and recommendations (Germany)
10. Guidelines for Quality Assurance of Laboratory Examinations of the
German Medical Association of 23.12.2019
Note on electromagnetic compatibility
a)
The photometer meets the requirements for electromagnetic radiation
and interference immunity as described in the IEC 61326 series of
standards.
b) Do not use this device near sources of intense electromagnetic radiation
because they may interfere with correct functioning. A distance of at
least 1 m should be maintained between an operational (switched on)
mobile phone and the photometer during measurement.
Note on the unit's internal quality control
The functionality of the device is checked when it is switched on. In addition,
electronically controlled checks are carried out for individual tests during the
measurement, which leads to an error message if specified requirements are
not met.
11. Appendix: “Step-by-step measurement”
Please refer to the illustrations in the "Step by step" instruction manual.