BS ISO 16142-2:2017，其中包括安全和性能的基本原则，确定了可用于评估医疗器械是否符合公认基本原则的重要标准和指南，当这些基本原则得到满足时，表明医疗器械是安全的，并按预期运行。本文件确定并描述了适用于所有医疗设备（包括IVD医疗设备（体外诊断））的六项安全和性能基本原则（见表B.1）。本文件还确定并描述了在设计和制造过程中需要考虑的与IVD医疗设备相关的其他安全和性能基本原则。 注:在设计过程中，制造商选择适用于特定医疗器械的设计和制造原则，并记录排除其他原则的原因。本文件旨在作为医疗器械制造商、标准制定机构、有管辖权的机构和合格评定机构的指南。交叉引用:CLSI EP07IEC 60825（所有部分）ISO 3951（所有部分）ISO 13408（所有部分）CLSI EP05IEC/ISO 80002-1ISO 22442（所有部分）ISO 11140（所有部分）CLSI POCT12IEC/ISO 80001-1ISO 16269（所有部分）ISO 17665（所有部分）ISO 2859（所有部分）ISO 11607（所有部分）ISO 11137（所有部分）CLSI EP12- A2IEC 62366-2CLSI EP06IEC 60068ISO/IEC 15026（所有部分）ISO 18113（所有部分）ISO/IEEE 11073（所有部分）CLSI EP26-AISO 14698（所有部分）ISO 11138（所有部分）ISO 14644（所有部分）IEC/ISO 80000（所有部分）ISO 17593:2007 Ed 1ISO 14971:2007 ASTM F2027-16IEC 62471:2006ISO 14161:2009ISO 25424:2009 Ed 1ISO 15882:2008 Ed 2IEC 60812:2006ISO/IEC 17025:2005ISO 15193:2009ISO24971:2013ISO 15194:2009 Ed 2IEC TR 80001-2-1:2012EN 14136:2004ISO 18153:2003 Ed 1ISO 18472:2006（R10）Ed 1ISO 13532:2002ISO 20857:2010 Ed 1ISO 17511:2003 Ed 1IEC 61010-2-101:2015ANSI/AAMI HE75: 2009IEC 61326-2-6:2012ISO 15197:2013 ED2ISO 15223-1:2016ISO/TS 13004:2013ASTM F2761-09（2013）ISO 14937:2009 Ed 2EN 13641:2002IEC 60878:1988IEC TR 80001-2-5:2014ISO 23640:2011IEC 62366-1:2015ISO 15195:2003 Ed 1IEC 62304:2006ISO 13485:2016EN 13612:2002ISO 11135:2014 Ed2购买本文件时可用的所有现行修订均包含在购买本文件中。

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 EP07IEC 60825 (all parts)ISO 3951 (all parts)ISO 13408 (all parts)CLSI EP05IEC/ISO 80002-1ISO 22442 (all parts)ISO 11140 (all parts)CLSI POCT12IEC/ISO 80001-1ISO 16269 (all parts)ISO 17665 (all parts)ISO 2859 (all parts)ISO 11607 (all parts)ISO 11137 (all parts)CLSI EP12-A2IEC 62366-2CLSI EP06IEC 60068ISO/IEC 15026 (all parts)ISO 18113 (all parts)ISO 11737 (all parts)ISO/IEEE 11073 (all parts)CLSI EP26-AISO 14698 (all parts)ISO 11138 (all parts)ISO 14644 (all parts)IEC/ISO 80000 (all parts)ISO 17593:2007 Ed 1ISO 14971:2007ASTM F2027 - 16IEC 62471:2006ISO 14161:2009ISO 25424:2009 Ed 1ISO 15882:2008 Ed 2IEC 60812:2006ISO/IEC 17025:2005ISO 15193:2009ISO/TR 24971:2013ISO 15194:2009 Ed 2IEC TR 80001-2-1:2012EN 14136:2004ISO 18153:2003 Ed 1ISO 18472:2006 (R10) Ed 1EN 13532:2002ISO 20857:2010 Ed 1ISO 17511:2003 Ed 1IEC 61010-2-101:2015ANSI/AAMI HE75:2009IEC 61326-2-6:2012ISO 15197:2013 ED2ISO 15223-1:2016ISO/TS 13004:2013ASTM F2761 - 09(2013)ISO 14937:2009 Ed 2EN 13641:2002IEC 60878:1988IEC TR 80001-2-5:2014ISO 23640:2011IEC 62366-1:2015ISO 15195:2003 Ed 1IEC 62304:2006ISO 13485:2016EN 13612:2002ISO 11135:2014 ED2All current amendments available at time of purchase are included with the purchase of this document.