|
标准号 |
版本 |
标准名称 |
|
ISO9001 |
2000 |
INTERNATIONAL
STANDARD
Quality
management systems-Requirements |
|
ISO11607 |
2003 |
Packaging
for terminally sterilized medical devices |
|
ISO11137 |
1995 |
INTERNATIONAL
STANDARD
Sterilization
of health care products-Requirement for validation and routine
control-Radiation sterilization |
|
ISO15197 |
2003 |
INTERNATIONAL
STANDARD
In
vitro diagnostic test systems- Requirements for blood-glucose monitoring
systems for self-testing in managing diabetes
mellitus |
|
ISO13485 |
2003 |
医疗器械 质量管理体系 用于法规的要求 |
|
ISO/DIS13485 |
2003 |
Quality
management systems-Medical devices-
System
requirements for regulatory purposes |
|
ISO14971-1 |
1998 |
医疗器械-风险管理-第一部分风险分析的应用 |
|
ISO14155-1 |
2003 |
INTERNATIONAL
STANDAR
Clinical
investigation of medical devices for human subjects-Part 1:General
requirements |
|
ISO14155-2 |
2003 |
INTERNATIONAL
STANDARD
Clinical
investigation of medical devices for human subjects-Part 2:Clinical
investigation plans |
|
QS-9000 |
1998 |
Quality
System Requirements |
