BS ISO 16142-2:2017 Medical devices -- Recognized essential principles of safety and performance of medical devices

BS ISO 16142-2:2017

Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

Status : Current   Published : September 2017

Format
PDF

Format
HARDCOPY



What is this standard about?

It identifies the significant standards and guides that can be used to assess if an In Vitro Diagnostic (IVD) medical device is safe and performs as intended.

Six general principles for safety and performance that apply to all IVD medical devices are outlined.  It also describes fundamental design and manufacturing criteria.

Who is this standard for?

IVD medical device manufacturers

Why should you use this standard?

Because it includes the specific essential principles for all IVD medical devices which were not included in the scope of part one.

What’s changed since the last update?

When the technical report on which this standard was based – ISO/TR 16142 – was revised, the technical committee decided to split the standard between non-IVD and IVD medical devices.

This standard also updates the technical report to take in the new essential principles set out by the international medical device regulators forum. 




Standard NumberBS ISO 16142-2:2017
TitleMedical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
StatusCurrent
Publication Date20 September 2017
Normative References(Required to achieve compliance to this standard)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, ISO 14971:2007, ASTM F2027 - 16, IEC 62471:2006, ISO 14161:2009, ISO 25424:2009, ISO 15882:2008, IEC 60812:2006, ISO/IEC 17025:2005, ISO 15193:2009, ISO/TR 24971:2013, ISO 15194:2009, IEC TR 80001-2-1:2012, EN 14136:2004, ISO 18153:2003, ISO 18472:2006, EN 13532:2002, ISO 20857:2010, ISO 17511:2003, IEC 61010-2-101:2015, ANSI/AAMI HE75:2009, IEC 61326-2-6:2012, ISO 15197:2013, ISO 15223-1:2016, ISO/TS 13004:2013, ASTM F2761 - 09(2013), ISO 14937:2009, EN 13641:2002, IEC 60878:1988, IEC TR 80001-2-5:2014
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsISO 16142-2:2017
Draft Superseded By15/30328959 DC16/30346073 DC
DescriptorsElectrical medical equipment, Safety measures, Equipment safety, Performance, Selection, Medical equipment, Acceptance (approval), Medical technology, Standards
ICS11.040.01
Title in FrenchDispositifs médicaux. Principes essentiels reconnus de sécurité et de performance des dispositifs médicaux Principes essentiels généraux et principes essentiels spécifiques supplémentaires pour tous les dispositifs médicaux de DIV et directives sur le choix des normes
CommitteeCH/210
ISBN978 0 580 91385 3
PublisherBSI
FormatA4
DeliveryYes
Pages52
File Size1.919 MB
Price£254.00


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