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.

Author: Meztijinn Zulkijinn
Country: Myanmar
Language: English (Spanish)
Genre: Travel
Published (Last): 7 November 2010
Pages: 97
PDF File Size: 7.19 Mb
ePub File Size: 17.81 Mb
ISBN: 352-8-94022-908-6
Downloads: 53666
Price: Free* [*Free Regsitration Required]
Uploader: Bralar

You may delete a document from your Alert Profile at any time.

Your basket is empty. Your Alert Profile lists the documents that io be monitored. Abstract 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.

Please first log in with a verified email before 14699 to alerts. Lignes directrices pour l’application de l’ISO Already Subscribed to this document. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.

ISO/TR 14969 Available with Guidance on ISO 13485

If the document is revised or amended, you will be notified by email. The faster, easier way to work with standards. Learn more about the cookies we use and how to change your settings.

  2SC5446 DATASHEET PDF

trr

This standard is also available to be included in Standards Subscriptions. Proceed to Checkout Continue Shopping. Please first verify your email before subscribing to alerts.

This guidance can be used to better understand the requirements of ISO and to illustrate the variety of methods and approaches available for meeting the requirements of ISO Medical equipment, Quality assurance systems, Design, Production management, Quality, Medical technology, Acceptance approvalMedical instruments, Quality assurance, Quality management, Installation, Maintenance.

History and related standards This International Standard includes the following cross-reference: Systemes de gestion de qualite.

You may find similar items within these categories by selecting from the choices below:. Standards Subsctiption may be the perfect 149969. 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.

ISO and ISO/TR Quality Management Systems Medical Devices Package

The guidance contained in this report can be useful as background kso for those representing quality management system assessors, conformity assessment bodies and regulatory enforcement bodies. Please download Chrome or Firefox or view our browser tips. Guidance on the application of ISO This standard is withdrawn. 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.

  JOPPICH TS 01 PDF

As the voice of the U. Find Similar Items This product falls into the following categories. This report does not include requirements to be 41969 as the uso of regulatory inspection or certification assessment activities. Guidance on the development, implementation and maintenance of quality management systems for medical devices ISO We use cookies to make our website isi to use and to better understand your needs. 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 14996 service medical devices, or that design, develop and provide related services.

Company organization, management and quality. Take the smart route to manage medical device compliance. It does not add to, or otherwise change, the requirements of ISO Accept and continue Learn more about the cookies we use and how to change your settings.