CENELEC
Project
| Reference | EN 62304:2006 |
|---|---|
| Title | Medical device software - Software life-cycle processes |
| Project Number | 16632 |
| Abstract/Scope | Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2006-07-12 |
| Current Stage code deadline | 2007-03-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC), AIMD (90/385/EEC), IVD (98/79/EC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 62304:2006 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Software; Medical; Life-cycle process |
| Note | Corrigendum to EN issued November 2008 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2006-06-01 |
|---|---|
| date of Availability (DAV) (2) | 2006-07-12 |
| date of Announcement (DOA) (3) | 2006-09-01 |
| date of Publication (DOP) (4) | 2007-03-01 |
| date of Withdrawal (DOW) (5) | 2009-06-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN ISO 14971:2012
|
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
