15/30321131 DC : 0
Superseded
View Superseded by
BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Hardcopy , PDF
English
02-29-2016
Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) - Comparison of content of
ISO 13485:2003 and ISO DIS2 13485:2015
Annex ZA (informative) - Relationship between this
European Standard and the Conformity Assessment
Requirements of EU Directive 90/385/EEC (as amended)
Annex ZB (informative) - Relationship between this
European Standard and the Conformity Assessment
Requirements of EU Directive 93/42/EEC (as amended)
Annex ZC (informative) - Relationship between this
European Standard and the Conformity Assessment
Requirements of EU Directive 98/79/EC (as amended)
Bibliography
BS EN ISO 13485.
| Committee |
CH/210/1
|
| DocumentType |
Draft
|
| Pages |
116
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.