DIN EN ISO 15883-2:2009 PDF

Scope: This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. The specified performance requirements of this part of IS~ 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that priori protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.

DIN EN ISO 15883-2:2009 Referenced Document

EN 10088-2 Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes*， 2014-10-01 Update
ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 Update
ISO 4017 Fasteners — Hexagon head screws — Product grades A and B*， 2022-06-28 Update
ISO 5356-2 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors AMENDMENT 1*， 2012-01-01 Update
ISO 5361 Anaesthetic and respiratory equipment — Tracheal tubes and connectors*， 2023-01-17 Update
ISO 5362 Anaesthetic reservoir bags
ISO 5367 Anaesthetic and respiratory equipment — Breathing sets and connectors*， 2023-07-01 Update
ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy

2023 DIN EN ISO 15883-2:2023-05 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023); German and English version prEN ISO 15883-2:2023 / Note: Date of issue 20...
2023 DIN EN ISO 15883-2:2023 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023); German and English version prEN ISO 15883-2:2023
2009 DIN EN ISO 15883-2:2009-09 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006); German version EN ISO 1...
2009 DIN EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006); English version of DIN EN