The list of new standards, current draft standards and projects is a selection that might be relevant for our clients. It therefore does not claim to be complete. The compilation has been made very carefully and serves as an overview for you. However, errors cannot be excluded, and we cannot assume any liability. The selection draws information from the following standards committees:
ISO 17420-1 (standard)
Respiratory protective devices
Performance requirements
Part 1: General
Date: 2021-01
ISO 10993-12 (Standard)
Biological evaluation of medical devices
Part 12: Sample preparation and reference materials
Date: 2021-01
ISO/TS 22421 (Standard)
Sterilization of health care products
Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Date: 2021-01
ISO 10993-23 (Standard)
Biological evaluation of medical devices
Part 23: Tests for irritation
Date: 2021-01
DIN EN ISO 11073-10101 (Norm)
Health informatics
Geräteinteroperabilität
Teil 10101: Kommunikation patientennaher medizinischer Geräte – Nomenklatur
Date: 2021-01
DIN EN ISO 28399 (Entwurf)
Dentistry
Äußere Zahnbleichmittel
Date: 2021-01
ISO/IEC CD 29138-3 (Project)
Information technology
Accessibility considerations for people with disabilities
Part 3: Guidance on user needs mapping
Date: 2021-01-28
DIN 33411-5 (Project)
Physical forces of the human body
Part 5: Maximum static action forces, values
Date: 2021-01-25
DIN EN ISO 27427 (Project)
Anaesthetic and respiratory equipment
Nebulizing systems and components
Date: 2021-01-13
DIN EN ISO 10651-5 (Projekt)
Respiratory equipment for medical use
Particular requirements for basic safety and essential performance
Teil 5: Gasbetriebene Notfall-Wiederbelebungsgeräte
Date: 2021-01-04
ISO/DIS 23417 (Project)
General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
Date: —
ISO/CD 10993-17.2 (Project)
Biological evaluation of medical devices
Part 17: Toxicological risk assessment of medical device constituents
Date: —
ISO/FDIS 10993-10 (Project)
Biological evaluation of medical devices
Part 10: Tests for skin sensitization
Date: —
ISO/CD 7176-31 (Project)
Wheelchairs
Part 31: Lithium-based battery technology
Date: —
ISO/DIS 7176-14 (Project)
Wheelchairs
Part 14: Power and control systems for electrically powered wheelchairs and scooters — Requirements and test methods
Date: —
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