BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices.

BS ISO 16142-1:2016

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

Status : Current   Published : March 2016

Format
PDF

Format
HARDCOPY



What is this standard about?

Medical device standards are a tool to demonstrate that a medical device is clinically effective and performs in a safe manner, where the medical benefits of the use of the device outweigh the risk of its use to the patient. They represent a consensus on the requirements that foster innovation while at the same time protecting public health.

The essential principles of safety and performance of medical devices are high-level requirements that when complied with ensure a medical device is safe and performs as intended. They were revised in 2012 to harmonize regulatory requirements for medical devices worldwide. 

This standard describes the relationship between the essential principles and medical device standards. 

Who is this standard for?

This standard will be useful to those who are looking for a better understanding of how to use standards and how they fit with the essential principles. It may be of particular interest to new starts and small medical device manufacturers.  

Why should you use this standard? 

It will help you understand:

  • Background on the development of standards and the use of terminology
  • The types of standards useful to demonstrate compliance
  • How to use standards during the medical device life-cycle phases

BS ISO 16142-1 also provides a table of standards that can be considered a starting point to determine which standards or which parts of a standard might be applicable to demonstrate conformity to the essential principles for all medical devices. 

There is also a list of additional principles for all non-IVD medical devices. This is a thorough mapping of published reference standards to the essential principles.

What’s changed since the last update?

This standard has been updated to reflect changes to the revised principles (previously published as a technical report).




Standard NumberBS ISO 16142-1:2016
TitleMedical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
StatusCurrent
Publication Date31 March 2016
Normative References(Required to achieve compliance to this standard)ISO 1135, ISO 3107, ISO 3826, ISO 5356, ISO 5359, ISO 5360, ISO 5361, ISO 5362, ISO 5364, ISO 5366, ISO 5367, ISO 5832, ISO 5834, ISO 5838, ISO 5840, ISO 5841, ISO 6474-1, ISO 7000, ISO 7010, ISO 7153-1, ISO 7197, ISO 7198, ISO 7199, ISO 7206, ISO 7207, ISO 7376, ISO 7396, ISO 7405, ISO 7494, ISO 7864, ISO 7886, ISO 8185, ISO 8536, ISO 8537, ISO 8637, ISO 8638, ISO 8827, ISO 8828, ISO 8835-7, ISO 9168, ISO 9170, ISO 9360, ISO 9583, ISO 9584, ISO 9626, ISO 9713, ISO 10079, ISO 10524, ISO 10555, ISO 10651, ISO 10993, ISO 11040, ISO/IEEE 11073, ISO 11135, ISO 11137, ISO 11138, ISO 11140, ISO 11197, ISO 11318, ISO 11607, ISO 11608, ISO 11663, ISO 11737, ISO/TS 13004, ISO 13402, ISO 13408, ISO 13485, ISO 13779, ISO 13782, ISO 13958, ISO 13959, ISO 14155, ISO 14160, ISO 14161, ISO 14242, ISO 14243, ISO 14408, ISO 14457, ISO 14602, ISO 14607, ISO 14630, ISO 14644, ISO 14698, ISO 14708, ISO 14879, ISO 14937, ISO/TR 14969, ISO 14971, ISO 15001, ISO 15002, ISO 15223-1, ISO 15882, ISO 15883, ISO 15985, ISO 16061, ISO 17510, ISO 17664, ISO 17665-1, ISO 18472, ISO 18777, ISO 18778, ISO 19054, ISO 20857, ISO 21534, ISO 21535
Informative References(Provided for Information)ISO 690, ISO/TS 19218-1, ISO/IEC Guide 51, ISO/IEC Guide 63, 2001/883/EC, 178/2002/EC, 1223/2009/EC
ReplacesPD ISO/TR 16142:2006
International RelationshipsISO 16142-1:2016
Draft Superseded By14/30290166 DC
DescriptorsMedical equipment, Medical technology, Electrical medical equipment, Equipment safety, Safety measures, Performance, Selection, Standards, Acceptance (approval)
ICS11.040.01
Title in FrenchDispositifs médicaux. Lignes directrices pour le choix des normes correspondant aux principes essentiels reconnus de sécurité et de performance des dispositifs médicaux
CommitteeCH/210
ISBN978 0 580 84345 7
PublisherBSI
FormatA4
DeliveryYes
Pages60
File Size1.73 MB
Price£254.00


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