for PPE produced as a single unit to fit an individual user, the range of permissible variations of relevant parameters based on the approved basic model;
maidir le TCP a tháirgtear mar aonad aonair a fheilfidh d'úsáideoir aonair, réimse éagsúlachtaí incheadaithe na bparaiméadar ábhartha bunaithe ar an mbunleagan formheasta;