Customer Support: 131 242

  • Shopping Cart
    There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

PN EN ISO 13485 : 2016

Current

Current

The latest, up-to-date edition.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)

Published date

12-01-2013

Sorry this product is not available in your region.

Committee
TC 247
DevelopmentNote
Supersedes PN EN 46003. (09/2007) Polish translation issued on 02/10/2017. (10/2017) NEW CHILD AMD 11 2022 IS NOW ADDED.
DocumentType
Standard
ProductNote
NEW CHILD AMD 11 2022 IS NOW ADDED. New child AC 2018 is now added
PublisherName
Polish Committee for Standardization
Status
Current
Supersedes

Standards Relationship
EN ISO 13485:2016 Identical
ISO 13485:2016 Identical

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.