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.
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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, Under review   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, Under review
Publication Date31 March 2016
Normative References(Required to achieve compliance to this standard)ISO 11140, ISO 5356, ISO 14602, IEC 61846, IEC 60731, ISO 8185, ISO 22675, ISO 13485, ISO 14879, ISO 5834, ISO 8536, IEC 60601-1-11, IEC 60601-1-9, ISO/IEC 15026, ISO 14243, ISO 13958, ISO 5832, ISO 25424, IEC 62359, ISO 14155, ISO/TR 14969, ISO 7199, ISO 26722, ISO 15882, ISO 10555, ISO 11138, ISO 8537, IEC 62366-1, ISO 21649, ISO 14937, ISO 13782, ISO 25539, IEC 60601-1-6, IEC 62471, ISO 81060, ISO 11135, ISO 9713, IEC 62083, IEC 60601-1-2, IEC 62220, ISO 9584, ISO 7010, IEC 60601-1, ISO 7198, ISO 21535, ISO 14644, ISO 23500, ISO 9168, ISO 9626, IEC 61391, ISO 23908, IEC 61303, ISO 14630, IEC 60336, ISO 14408, ISO 23747, ISO 5841, ISO/TS 13004, ISO 5359, ISO 7197, ISO 15223-1, ISO 11040, ISO 8827, ISO 11607, ISO 13779, ISO 80369, ISO 8638, ISO 10079, ISO 13959, ISO 8637, IEC 60601-2, ISO 7396, ISO 10651, ISO 18777, IEC 60601-1-3, ISO 21969, ISO 10993, ISO 11137, IEC 61676, ISO 5367, ISO 17665-1, ISO 14607:2018, IEC 60580, IEC 60627, ISO 7376:2020, ISO 6474-1:2019, IEC 60522, ISO 13408, IEC 60417, ISO/IEEE 11073, ISO 22612, ISO 7494, ISO 15985, ISO 9170, ISO 15002, ISO 19054, ISO 11197, IEC 60118-15, ISO
Informative References(Provided for Information)ISO 690, ISO/IEC GUIDE 63:2019, 2001/883/EC, 1223/2009/EC, ISO/TS 19218-1, ISO/IEC Guide 51, 178/2002/EC
ReplacesPD ISO/TR 16142:2006
International RelationshipsISO 16142-1:2016
Draft Superseded By14/30290166 DC
DescriptorsSelection, Medical technology, Acceptance (approval), Standards, Safety measures, Electrical medical equipment, Performance, Equipment safety, Medical equipment
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 Size1.604 MB
Price£260.00


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