ISO TR 14969 PDF

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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Medical equipment, Quality assurance systems, Design, Production management, Quality, Medical technology, Acceptance approvalMedical instruments, Quality assurance, Quality management, Installation, Maintenance. As the voice of the U. Need more than one copy? Click to learn more.

ISO/TR 14969 Available with Guidance on ISO 13485

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 report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. 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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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. This standard is withdrawn.

Guidance on the application of ISO Please first log in with a verified email before subscribing to alerts. Proceed to Checkout Continue Shopping. The faster, easier way to work with standards. History and related standards This International Standard includes the following cross-reference: Please download Chrome or Firefox or view our browser tips.

Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

ISO and ISO/TR Quality Management Systems Medical Devices Package

Find Similar Items This product falls into the following categories. You may find similar items within these categories by selecting from the choices below:. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services.

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Company organization, management and quality. Lignes directrices pour l’application de l’ISO Search all products by. If the document is revised or amended, you will be notified by email. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.

Take the smart route to manage medical device compliance.

Abstract This International Standard Ios 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.

This standard is also available to be included in Standards Subscriptions. It does not add to, or otherwise change, the requirements of ISO Guidance on the development, implementation and maintenance of quality management systems for medical devices ISO Learn more about the cookies we use and how to change your settings.

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