BS ISO 16142-2:2017, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This document identifies and describes the six general essential principles of safety and performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic).

This document also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to IVD medical devices.

NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.

This document is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.


Cross References:
CLSI EP07
IEC 60825 (all parts)
ISO 3951 (all parts)
ISO 13408 (all parts)
CLSI EP05
IEC/ISO 80002-1
ISO 22442 (all parts)
ISO 11140 (all parts)
CLSI POCT12
IEC/ISO 80001-1
ISO 16269 (all parts)
ISO 17665 (all parts)
ISO 2859 (all parts)
ISO 11607 (all parts)
ISO 11137 (all parts)
CLSI EP12-A2
IEC 62366-2
CLSI EP06
IEC 60068
ISO/IEC 15026 (all parts)
ISO 18113 (all parts)
ISO 11737 (all parts)
ISO/IEEE 11073 (all parts)
CLSI EP26-A
ISO 14698 (all parts)
ISO 11138 (all parts)
ISO 14644 (all parts)
IEC/ISO 80000 (all parts)
ISO 17593:2007 Ed 1
ISO 14971:2007
ASTM F2027 - 16
IEC 62471:2006
ISO 14161:2009
ISO 25424:2009 Ed 1
ISO 15882:2008 Ed 2
IEC 60812:2006
ISO/IEC 17025:2005
ISO 15193:2009
ISO/TR 24971:2013
ISO 15194:2009 Ed 2
IEC TR 80001-2-1:2012
EN 14136:2004
ISO 18153:2003 Ed 1
ISO 18472:2006 (R10) Ed 1
EN 13532:2002
ISO 20857:2010 Ed 1
ISO 17511:2003 Ed 1
IEC 61010-2-101:2015
ANSI/AAMI HE75:2009
IEC 61326-2-6:2012
ISO 15197:2013 ED2
ISO 15223-1:2016
ISO/TS 13004:2013
ASTM F2761 - 09(2013)
ISO 14937:2009 Ed 2
EN 13641:2002
IEC 60878:1988
IEC TR 80001-2-5:2014
ISO 23640:2011
IEC 62366-1:2015
ISO 15195:2003 Ed 1
IEC 62304:2006
ISO 13485:2016
EN 13612:2002
ISO 11135:2014 ED2


All current amendments available at time of purchase are included with the purchase of this document.