# Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance), Article 16: Chemical disinfection

Extent: E+W+S+N.I.

Procedures for chemical disinfection referred to in point (e) of Article 11 shall cover the following, if applicable:
(a) identification and concentration of chemicals required for the disinfection process;
(b) contact time of the disinfectant;
(c) temperature(s) to be used;
(d) limits on temperature, concentration of solution(s), exposure time;
(e) description of the accessories required for the disinfection process;
(f) identification of water quality required;
(g) techniques to be used including rinsing volume and time;
(h) limits and monitoring of chemical residues remaining on the single-use device after disinfection;
(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;
(j) criteria and/or requirements for approval or rejection.

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Source: https://www.legislation.gov.uk/eur/2020/1207/article/16 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.