Points are awarded if the parts of the equipment and medical supplies that are in contact with tissue and body fluids are free from substances classified with the hazard phrases below, as specified in Regulation (EC) No 1272/2008 of the European Parliament on classification, labelling and packaging of substances and mixtures (the CLP Regulation). The concentration shall not exceed 0.1% by weight per substance in each individual part of the product.
Classification according to regulation 1272/2008 |
Hazard class and category |
Hazard phrase |
Carcinogenicity |
H350 |
Mutagenic |
H340 |
Reproductive toxicity |
H360 |