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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2014); German version prEN ISO 13485:2014
| 분야 | |
|---|---|
| 적용범위 | |
| 국제분류(ICS)코드 |
03.100.70 : 관리시스템
11.040.01 : 일반 의료장비 |
| 페이지수 | 180 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | DIN EN ISO 13485:2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (includes Corrigendum :2018) | 2021-12-01 | 표준 |
| 2 | DIN EN ISO 13485:2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 | 2021-12-01 | 표준 |
| 3 | DIN EN ISO 13485 Berichtigung 1:2017-07 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) , Corrigendum to DIN EN ISO 13485:2016-08 | 2017-07-01 | 구판 |
| 4 | DIN EN ISO 13485 Berichtigung 1:2017-07 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016 | 2017-07-01 | 구판 |
| 5 | DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 | 2016-08-01 | 구판 |
| 6 | DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 2016-08-01 | 구판 |
| 7 | DIN EN ISO 13485:2015-05 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015 | 2015-05-01 | 초안 |
| 8 | DIN EN ISO 13485:2014-04 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2014); German version prEN ISO 13485:2014 | 2014-04-01 | 초안 |
| 9 | DIN EN ISO 13485:2012-11 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012 | 2012-11-01 | 구판 |
| 10 | DIN EN ISO 13485:2012-11 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum :2012) | 2012-11-01 | 구판 |
| 11 | DIN EN ISO 13485:2010-01 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009 | 2010-01-01 | 구판 |
| 12 | DIN EN ISO 13485:2010-01 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum AC:2009) | 2010-01-01 | 구판 |
| 13 | DIN EN ISO 13485:2007-10 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007 | 2007-10-01 | 구판 |
| 14 | DIN EN ISO 13485:2007-10 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (includes Corrigendum AC:2007) | 2007-10-01 | 구판 |
| 15 | DIN EN ISO 13485:2003-11 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003 | 2003-11-01 | 구판 |
| 16 | DIN EN ISO 13485:2003-11 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | 2003-11-01 | 구판 |
| 17 | DIN EN ISO 13485:2001-02 | Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (ISO 13485:1996); English version of DIN EN ISO 13485 | 2001-02-01 | 구판 |
| 18 | DIN EN ISO 13485:2001-02 | Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (Identical to ISO 13485:1996); German version EN ISO 13485:2000 | 2001-02-01 | 구판 |
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