Lapaʻau CE hou papa IIA CE huahana palapala Lapaʻau CE hou IIB CE huahana palapala Palapala hōʻoia o ka huahana CE no ke ʻano hou I sterilization o ka lāʻau lapaʻau CE Lapaʻau ISO hou super Union Medical Lapaʻau FDA palapala