ISO 16142-1:2016 - $185.00   BUY NOW

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

ISO 16142-1:2016 Publication Description:

ISO 16142:2016, 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 part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).

ISO 16142:2016also 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 medical devices other than IVD medical devices. Future ISO 16142‑2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of 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.

ISO 16142:2016 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Medical-Equipment General (11.040.01)

ICS Related Standards

Cart Document Number Document Title
$240.00 ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
$240.00 ISO/TR 14969:2004 Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
$232.00 ISO 14971:2007 Medical devices - Application of risk management to medical devices
$138.00 ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
$149.00 ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
$103.00 ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
$103.00 ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
$149.00 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
$209.00 ISO 15378:2015 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
$123.00 ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
$103.00 ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
$19.00 ISO/TS 19218-1:2011/Amd1:2013 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes- Amendment 1
$103.00 ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
$45.00 ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
$68.00 ISO/TR 24971:2013 Medical devices - Guidance on the application of ISO 14971
$103.00 ISO/TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
$232.00 ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
$45.00 ISO/PAS 18761:2013 Use and handling of medical devices covered by the scope of ISO/TC 84 - Risk assessment on mucocutaneous blood exposure
$58.00 JIS Q 14971-1:2001 Medical devices -- Risk management -- Part 1: Application of risk analysis
$290.00 JIS T 0601-1-2:2012 Medical electrical equipment -- Part 1-2: General requirements for safety -- Electromagnetic compatibility -- Requirements and tests
$242.00 JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
$185.00 ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
$232.00 ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
$209.00 ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)