공지사항
자료실
List of Articles
번호 제목 글쓴이 날짜 조회 수
16 Machinery Directive  Admin 2018.07.05 3913
15 IAF MD 9:2017  Admin 2017.09.05 876
14 MEDDEV 2.7.1 Rev. 4판 발간 및 적용  Admin 2017.09.05 1268
13 IAF ID10 ISO 14001_2015 전환지침 (국문)  Admin 2017.09.05 660
12 IAF ID9 ISO 9001_2015 전환지침 (국문)  Admin 2017.09.05 703
11 Preliminary Questionnaire for Medical Devices certification  Admin 2017.07.05 509
10 Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998)  cungunj 2017.03.06 989
9 Council Directive 93/42/EEC on Medical Devices (MDD) (1993)  cungunj 2017.03.06 873
8 MEDDEV 2.1/6 - Qualification and Classification of stand alone software  cungunj 2017.03.06 1778
7 MEDDEV 2.1/5 - Medical devices with a measuring function  cungunj 2017.03.06 1273
6 interpretative document of 21 August 2009 - For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services  cungunj 2017.03.06 498
5 MEDDEV 2.1/4 - Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment  cungunj 2017.03.06 1389
4 MEDDEV 2.1/3 rev.3 - Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative  cungunj 2017.03.06 1211
3 MEDDEV 2.1/2.1 - Treatment of Computers Used to Program Implantable Pulse Generators  cungunj 2017.03.06 508
2 MEDDEV 2.1/2 rev.2 - Field of application of directive “active implantable medical devices”  cungunj 2017.03.06 457
1 MEDDEV 2.1/1 - Definitions of “medical devices”, “accessory” and “manufacturer”  cungunj 2017.03.06 1053
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