I.S. EN 62304:2006/A1:2015
Current
Medical device software - Software life-cycle processes (IEC 62304:2006/A1:2015)
Hardcopy , PDF
English - French
11-03-2015
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.
FOREWORD
INTRODUCTION
1 Scope
2 * Normative references
3 * Terms and definitions
4 * General requirements
5 Software development PROCESS
6 Software maintenance PROCESS
7 * Software RISK MANAGEMENT PROCESS
8 * Software configuration management PROCESS
9 * Software problem resolution PROCESS
Annex A (informative) Rationale for the requirements of this standard
Annex B (informative) Guidance on the provisions of this standard
Annex C (informative) Relationship to other standards
Annex D (informative) Implementation
Bibliography
This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-2720-6
|
| Pages |
220
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 62304:2006/AMD1:2015 | Identical |
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.