miniland baby Thermotalk plus Instrucciones De Uso página 118

Miniland S.A. P.Ind. La Marjal I C/ La Patronal s/nº. 03430 ONIL (Alicante) ESPAÑA
Customer Service. +34 965 564 200 www.minilandbaby.com · baby@miniland.es
We declare under our own responsibility that the product:
thermotalk plus · Miniland Baby · 89068 · Miniland, S.A.
to which this declaration refers conforms with the relevant standards or other
- Directive 93/42/EEC Medical devices
- EN 60601-1:1998+A1:1991+A2:1995 Medical electrical equipment
- Part 1:General requirements for safety
- EN 60601-1-2: 2007 Medical electrical equipment
- Part 1-2: General requirements for basic safety and essential performance
- Collateral standard: Electromagnetic phenomena - Requirements and tests
- EN ISO 13485:2003/AC:2007 Medical devices- Quality management systems
- requirements for regulatory purposes
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation
and testing
- ISO 10993-5:2009 Biological evaluation of medical devices
- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2002+Amd 1:2996 Biological evaluation of medical devices
- Part 10: Tests for irritation and skin sensitization
- ISO 10993-12:2007 Biological evaluation of medical devices
- Part 12: Sample preparation and reference materials
- EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red
ear thermometers (with maximum device)
- Pls delete it, It's no available for our product
- Directive 2006/66/EC, Batteries and accumulators and waste batteries
and accumulator (Heavy metals in battery)
- Directive 2002/95/EC RoHS (Restriction of the use of certain hazardous
substances in electrical and electronic equipment)
- REACH Regulation (Registration, Evaluation, Authorisation and
Restriction of Chemical substances)
- Directive 2002/96/EC Waste electrical and electronic equipment (WEEE),
EN 50419:2006 for symbol
standardising documents:
Miniland, S.A.
P.P.
José Verdú Francés
Onil, Alicante, Spain. 5th October 2011