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ISO/TC 210  - Менеджмент качества и общие аспекты медицинского оборудования

Темы (или пункты), которые надо показать:


Стандарты и проекты под прямой ответственностью ISO/TC 210 Секретариат

Стандарт и/или проектСтадияМКС
ISO/DIS 13485
Medical devices -- Quality management systems -- Requirements for regulatory purposes
40.20 11.040.01
03.120.10
ISO/AWI 15225
Medical devices -- Quality management -- Medical device nomenclature data structure
20.00
ISO/DIS 16142-1
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
40.00 11.040.01
ISO/NP 16142-2
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
10.99
ISO/CD 18250-3
Small-bore connectors for reservoir delivery systems -- Part 3: Connectors for enteral applications.
30.60 11.040.25
ISO/CD 18250-8
Small-bore connectors for reservoir delivery systems -- Part 8: Connectors for citrate-based anticoagulant solution for apheresis applications
30.60 11.040.25
ISO/NP 19081
Connectors for citrate-based anticoagulant solution reservoirs for apheresis
10.99
IEC 62304:2006/DAmd 1
40.20 11.040.01
35.240.80
IEC/DIS 62366-1
Medical devices -- Part 1: Application of usability engineering to medical devices
40.60 11.040.01
ISO/AWI TR 80002-2
Medical device software -- Part 2: Validation of software for regulated processes
20.00
IEC/DTR 80002-3
Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
30.60 11.040.01
35.240.80
ISO/CD 80369-1
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
30.60 11.040.20
11.040.10
ISO/CD 80369-2
Small bore connectors for liquids and gases in healthcare applications -- Part 2: Connectors for breathing systems and driving gases applications
30.60 11.040.20
11.040.10
ISO/DIS 80369-3
Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
40.99 11.040.25
IEC/DIS 80369-5
Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications
40.60 11.040.25
ISO/CD 80369-6
Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications
30.60 11.040.25
ISO/DIS 80369-7
Small bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
40.60 11.040.25
ISO/DIS 80369-20
Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods
40.60 11.040.25