prEN ISO 15883-6 rev

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noncritical medical devices and health care equipment prEN ISO 15883-6 rev

General information

30.99 CD approved for registration as DIS   Dec 11, 2024

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

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 legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 15883-6:2015

NOW

IN_DEVELOPMENT
prEN ISO 15883-6 rev
30.99 CD approved for registration as DIS
Dec 11, 2024