Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014

2Scope / Description

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WDs) and their accessories for cleaning and sterilizing reusable medical devices and other items used in medical, dental, pharmaceutical and veterinary practices. It specifies the performance requirements for cleaning and sterilization, and the accessories required to achieve the necessary performance. It also specifies the methods and instruments required for validation, routine control and monitoring, and revalidation (after periodic and necessary maintenance). This part of ISO 15883 does not apply to machines used for laundry or general catering purposes. This part of ISO 15883 does not include requirements for machines used to sterilize loads or called "sterilizers", which are specified in other standards, such as EN 285. The performance requirements of this standard may not ensure the inactivation or removal of the pathogen of transmissible spongiform encephalopathy (prion protein). If prion protein is considered to be possible, special attention needs to be paid to the selection of disinfectants and cleaning agents to ensure that the chemicals used do not react with prion protein in a way that may inhibit its removal or inactivation.