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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/IEC CD Guide 63
Guide to the development and inclusion of safety aspects in International Standards for medical devices
30.99 11.020
01.120
ISO/NP 14971
Medical devices -- Application of risk management to medical devices
10.99 11.040.01
ISO/DIS 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
40.60 11.040.01
ISO/CD 18250-1
Connectors for reservoir delivery systems for healthcare applications -- Part 1: General requirements and common test methods
30.60 11.040.25
ISO/DIS 18250-3
Connectors for reservoir delivery systems for healthcare applications -- Part 3: Enteral applications
40.99 11.040.25
ISO/CD 18250-6
Connectors for reservoir delivery systems for healthcare applications -- Part 6: Neural applications
30.99 11.040.25
ISO/CD 18250-7
Connectors for reservoir delivery systems for healthcare applications -- Part 7: Conectors for Intravascular Infusion
30.99 11.040.25
ISO/DIS 18250-8
Connectors for reservoir delivery systems for healthcare applications -- Part 8: Citrate-based anticoagulant solution for apheresis applications
40.99 11.040.25
ISO/DTR 80002-2
Medical device software -- Part 2: Validation of software for medical device quality systems
30.60 11.040.01
35.240.80
ISO/DIS 80369-1
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
40.99 11.040.20
11.040.10