I.S. EN ISO 13485:2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Hardcopy , PDF
09-10-2018
English
01-01-2000
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.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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Superseded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 |
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.