Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $213.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $330.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full 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.

 

Document History

  1. ISO 16142-1:2016

    👀currently
    viewing


    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

    • Most Recent
  2. 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

    • Historical Version
  3. ISO/TR 16142:1999


    Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

    • Historical Version