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DIN Standards Committee Health Technologies

Overview

This European Standard describes a risk management approach, called Risk Analysis and Biocontamination Control (RABC), designed to enable laundries to continuously assure the microbiological quality of laundry processed textiles. The RABC approach applies for laundry market sectors where it is necessary to control biocontamination, such as pharmaceuticals, medical devices, food, healthcare and cosmetics. The RABC approach excludes those aspects relating to worker safety and sterility of the final product. This standard differs from DIN EN 14065:2003-02 as follows: a) the entire standard has been revised to put laundries in the position to ensure the effective and consistent provision of processed textiles with an appropriate microbiological quality with the help of a Risk Analysis and Biocontamination Control (RABC) system; b) in Clause 3, new definitions for "acceptance criteria", "control measure", "control point", "cross contamination", "decontamination", "prerequisites" and "process validation" have been added; c) Clause 4 has been restructured, and a figure showing the risk management process using an RABC system has been added; d) Clause 6 has been completely revised and restructured, and a new paragraph 6.2.3 "Prerequisites programme (PRP) " has been added; e) Annex A (informative) has been completely revised and the title changed to "Rationale for application of RABC in laundries"; f) Annex B (informative) now includes "Examples of prerequisites"; g) Annex C (informative) now provides "Examples and guidance for risk assessment"; h) a new Annex D (informative) "Control concepts illustration" has been added; i) a new Annex E (informative) "Examples of wash process aspects" has been added; j) a new Annex F (informative) "Examples of approaches to process validation for laundries" has been added; k) a new Annex G (informative) "Synopsis of EN ISO 9001:2008 and EN 14065:2016" has been added; l) the Bibliography has been updated. The committee responsible for this standard is NA 106-01-12 AA "Industrielles Waschen/Biokontamination; SpA zu CEN/TC 248/WG 17 und ISO/TC 38/SC 2/WG 9" ("Industrial washing/Biocontamination; mirror committee to CEN/TC 248/WG 17 and ISO/TC 38/SC 2/WG 9") at DIN.

Document: references other documents

Responsible national committee

NA 106-01-12 AA - Industrial washing/Biokontamination; Mirror committee to CEN/TC 248/WG 17 and ISO/TC 38/SC 2/WG 9  

Responsible european committee

CEN/TC 248/WG 17 - Hygienic quality of textiles processed in industrial laundries and used in sectors in which it is necessary to contol biocontamination