EN ISO 13485:2003 + AC:2007
German: 4057_48_11_0_d
English: 4057_48_11_0_e
French: 4057_48_11_0_f
Italian: 4057_48_11_0_i
EU directive 98/79/EC
German: 4057_21_11_0_d
English: 4057_21_11_0_e
French: 4057_21_11_0_f
Italian: 4057_21_11_0_i