18/30350509 DC

Действует

BS ISO 20069. Guidance for assessment and evaluation of changes to drug delivery systems — 41 стр.

Ссылочные документы

Действует

Aerosol drug delivery device design verification -- Requirements and test methods — 50 стр.

Действует

Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 1: General requirements — 56 стр.

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

Действует

Needle-free injectors for medical use -- Requirements and test methods — 40 стр.

Заменен

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.

Заменен

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.

Заменен

Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems — 48 стр.

Действует

Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and catheters — 10 стр.

Действует

Medical device software - Software life cycle processes — 78 стр.

Действует

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance — 0 стр.