관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
구판
판매
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
| 언어 | 제공형태 | 판매가격 | 선택 |
|---|---|---|---|
|
(정오표) 독어 |
|
- |
| 분야 | |
|---|---|
| 적용범위 | |
| 국제분류(ICS)코드 |
03.100.70 : 관리시스템
11.040.01 : 일반 의료장비 |
| 페이지수 | 23 |
| 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 |
관련상품이 존재하지 않습니다.
함께 구입한 상품이 존재하지 않습니다.
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
KS표준
핸드북
