Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Secure PDF

      Secure PDF Files

      Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.

        What you can do with a Secure PDF:
      • Print
      • Search
      • Highlight
      • Bookmark
      Please note that some publishers - including BOMA, IADC and NRC - do not allow printing of their documents.

    • 👥
    • Immediate download
    • $86.36 $69.09
      you save $17.27
    • Add to Cart
    • Printed Edition
    • Ships in 1-2 business days
    • $86.36 $69.09
      you save $17.27
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $116.84
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

To be read in conjunction with BS EN ISO 9001:1994

Cross References: EN ISO 8402:1995*ISO 8402:1994*EN ISO 9001:1994*ISO 9001:1994*ISO 1137:1995*

Also available as part of KIT 160.

Replaces BS EN 46001:1997 which remains current.

Replaced by BS EN ISO 13485:2003 but remains current.
 

Document History

  1. BS EN ISO 13485:2016


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Most Recent
  2. BS EN ISO 13485:2012


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  3. BS EN ISO 13485:2003


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  4. BS EN ISO 13488:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002

    • Historical Version
  5. BS EN ISO 13485:2001

    👀currently
    viewing


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

    • Historical Version
  6. BS EN 46003:1999


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

    • Historical Version
  7. BS EN 46001:1997


    Specification for application of EN ISO 9001 to the manufacture of medical devices

    • Historical Version
  8. BS EN 46002:1997


    Specification for application of EN ISO 9002 to the manufacture of medical devices

    • Historical Version