The ISO and ISO/TR Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality. Dear all As the ISO disappears and will be converted in a iso handbook please change the forum title of this section:thanx: Xavier. Buy ISO/TR Medical devices – Quality management systems – Guidance on the application of ISO from SAI Global.
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Need more than one copy? Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices. As the voice of the U. Subscription pricing is determined by: You may experience issues viewing this site in Internet Explorer 9, 10 or This standard is withdrawn.
Click to learn more. Lignes directrices pour l’application de l’ISO It provides guidance related to quality management systems for a wide variety of medical devices and related services, such as active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices. This International Standard Technical Report provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of ISO for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services.
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Medical equipment, Quality assurance systems, Design, Production management, Quality, Medical technology, Acceptance approvalMedical instruments, Quality assurance, Quality management, Installation, Maintenance.
ISO and ISO/TR Quality Management Systems Medical Devices Package
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ISO/TR 14969 Available with Guidance on ISO 13485
History and related standards This International Standard includes the following cross-reference: Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards.
The faster, easier way to work with standards. If the document is revised or amended, you will be notified by email. Abstract This International Standard Technical Report provides guidance to assist in the development, implementation and maintenance of quality management systems that jso to meet the requirements of ISO for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services.
It does isk add to, or otherwise change, the requirements of ISO This report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.
Please first log in with a verified email before subscribing to alerts. Learn more about the cookies we use and how to change your settings. This guidance can be used to better understand the requirements of ISO and to illustrate the variety of iiso and approaches available for meeting the requirements of ISO You may find similar items within these categories by selecting from the choices below:.
This standard is also iiso to be included in Standards Subscriptions. The guidance contained in this report can be useful as background information for those representing quality management system assessors, conformity assessment bodies and regulatory enforcement bodies.
PD CEN ISO/TR 14969:2005
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