ANSI/AAMI/ISO 16142-2-2017 pdf download.Medical devices— Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specifc essential principles for all IVD medical devices and guidance on the selection of standards.
This document, 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 document identifies and describes the six general essential principles of safety and performance (see Table B.1 ) that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
This document also 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 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.
This document is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 2859 (all parts), Sampling procedures for inspection by attributes
ISO 3951 (all parts), Sampling procedures for inspection by variables
ISO 1 1 1 35, Sterilization of health-care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1 1 1 37 (all parts), Sterilization of health care products—Radiation
ISO 1 1 1 38 (all parts), Sterilization of health care products—Biological indicators
ISO 1 1 1 40 (all parts), Sterilization of health care products—Chemical indicators
ISO 1 1 607 (all parts), Packaging for terminally sterilized medical devices
ISO 1 1 737 (all parts), Sterilization of medical devices—Microbiological methods
ISO/TS 1 3004, Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD.ANSI/AAMI/ISO 16142-2 pdf download.