DIN EN 60601-1-10 VDE 0750-1-10:2016-04

* German Language Version *

Medical electrical equipment

Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

(IEC 60601-1-10:2007 + A1:2013); German version EN 60601-1-10:2008 + A1:2015
Class/Status: Standard, valid
Released: 2016-04
VDE Art. No.: 0700947

Contents

The first edition of IEC 60601-1-10 was published in 2007. This amendment is intended to update the references to IEC 60601-1:2005 to include Amendment 1:2012, IEC 60601-1-6:2006 to IEC 60601-1-6:2010 including its Amendment 1 and IEC 60601-1-8:2006 to include its Amendment 1:2012. This amendment also removes the normative reference to IEC 62304:2006. This collateral standard made referenced to IEC 62304 because elements of the software process were not fully covered by Clause 14 of IEC 66001-1:2005. Amendment 1 to IEC 60601-1:2005 incorporates the needed software process requirement into Clause 14. Therefore, in is redundant and potentially confusing to have the explicitly called out in this collateral standard.

Replacement for:
DIN EN 60601-1-10 VDE 0750-1-10:2008-11

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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