ANSI/AAMI/ISO 16142-1-2016 pdf download.Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specifc essential principles for all non-IVD medical devices and guidance on the selection of standards.
This part of ISO 16142, 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).
This part of ISO 16142 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 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.
This part of ISO 16142 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, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1135 (all parts), Transfusion equipment for medical use
ISO 3107, Dentistry—Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
ISO 3826 (all parts), Plastics collapsible containers for human blood and blood components
ISO 5356 (all parts), Anaesthetic and respiratory equipment—Conical connectors
ISO 5359, Anaesthetic and respiratory equipment—Low-pressure hose assemblies for use with medical gases
ISO 5360, Anaesthetic vaporizers—Agent-specific filling systems.ANSI/AAMI/ISO 16142-1 pdf download.