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SRPS EN ISO 15883-6:2017

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

Jan 31, 2017

General information

60.60     Jan 31, 2017

ISS

Z076

European Norm

11.080.10  

English  

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Scope

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15883-6:2012

NOW

PUBLISHED
SRPS EN ISO 15883-6:2017
60.60 Standard published
Jan 31, 2017

REVISED BY

PROJECT
dnaSRPS EN ISO 15883-6:2022

Related project

Adopted from EN ISO 15883-6:2015

Adopted from ISO 15883-6:2011 IDENTICAL