CENELEC
Project
| Reference | EN ISO 13485:2003 |
|---|---|
| Title | Medical devices - Quality management systems - Requirements for regulatory purposes |
| Project Number | 22630 |
| Abstract/Scope | |
| Status |
Withdrawn
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2003-07-15 |
| Current Stage code deadline | |
| Deadline date for vote |
Legal
| Directive(s) | |
|---|---|
| Mandate(s) | |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | ISO 13485:2003 (EQV) |
| ICS | |
| Keywords | |
| Note | Corrigendum to EN issued August 2009 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2003-06-15 |
|---|---|
| date of Availability (DAV) (2) | 2003-07-15 |
| date of Announcement (DOA) (3) | - |
| date of Publication (DOP) (4) | - |
| date of Withdrawal (DOW) (5) | - |
Relations
| Supersedes | EN ISO 13485:2000 EN ISO 13488:2000 EN 46003:1999 |
|---|---|
| Superseded by | EN ISO 13485:2012 |
| Normative reference (6) |
(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Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn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.
