• There are no items in your cart

I.S. EN ISO 13485:2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

10-09-2018

Language(s)

English

Published date

01-01-2000

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

This International Standard specifies, in conjunction with ISO 9001, the quality System requirements for the
design/development, production and, when relevant, installation and servicing of medical devices.

Committee
TC 210
DocumentType
Standard
Pages
20
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

View more information
US$40.56
Excluding Tax where applicable

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.