Procedures for chemical disinfection referred to in point (e) of Article 11 shall cover the following, if applicable:

1. (a)

   identification and concentration of chemicals required for the disinfection process;

2. (b)

   contact time of the disinfectant;

3. (c)

   temperature(s) to be used;

4. (d)

   limits on temperature, concentration of solution(s), exposure time;

5. (e)

   description of the accessories required for the disinfection process;

6. (f)

   identification of water quality required;

7. (g)

   techniques to be used including rinsing volume and time;

8. (h)

   limits and monitoring of chemical residues remaining on the single-use device after disinfection;

9. (i)

   limits and monitoring of chemical residues remaining on the single-use device from cleaning agents to ensure these residues do not interact adversely with the disinfectant;

10. (j)

    criteria and/or requirements for approval or rejection.