Miniland, S.A.
P.P.
Onil, Alicante, Spain.
8th March 2012
José Verdú Francés
Miniland S.A. P.Ind. La Marjal I C/ La Patronal s/nº. 03430 ONIL (Alicante) SPAIN
Technical support: +34 966 557 775 · www. baby.com · miniland@miniland.esminiland
DECLARATION OF CONFORMITY
We declare under our own responsibility that the product:
nasal care · Miniland Baby · 89058 · Miniland, S.A.
to which this declaration refers conforms with the
relevant standards or other standardising documents:
· Medical Devices Directive 93/42/EEC
- EN 60601-1: 2006 Medical electrical equipment; Part 1: General requirements for basic
safety and essential performance.
- EN 60601-1-2:2007 Medical electrical equipment. Part 1-2: General requirements for
basic safety and essential performance. Collateral standard. Electromagnetic
Compatibility. Requirements and test.
- ISO 13485:2003 Medical Devices. Quality management systems. Requirements for
regulatory purposes.
- ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and
delayed-typed hypersensitivity
- ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation
and reference materials
· Electromagnetic Compatibility Directive 2004/108/EC
- Emission: CISPR 11:2003+A1:2004, Class B. Industrial, scientific and medical (ISM)
radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and
methods of measurement
- Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2008, IEC 61000-4-8:2009
Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques
· RoHS Directive - Restriction of the use of certain hazardous substances in electrical
and electronic equipment (2002/95/EC)
· REACH(Registration, Evaluation, Authorization and Restriction of Chemical substances)
Regulation (EC) No 1907/2006- 46 SVHC
· PAHs (Polynuclear Aromatic Hydrocarbons) requirement according to (Category I) of
ZEK 01.2-8 of German ZLS and its amendments