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 11139 AMD 1 (Standard)
Sterilization of health care products
Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions
Date: 2024-01
DIN EN ISO 11608-3 (Standard)
Needle-based injection systems for medical use - Requirements and test methods
Part 3: Containers and integrated fluid paths
Date: 2024-01
ISO/TS 5499:2024 (Standard)
Health informatics — Clinical particulars
Core principles for the harmonization of therapeutic indications terms and identifiers
Date: 2024-01
ISO/AWI 23421 (Project)
Medical devices - Terminology
Terms used in the field of quality management and corresponding general aspects for products with a health purpose including medical devices
Date: 2024-01
DIN EN ISO 20417 rev (Project)
Medical Devices
Information to be supplied by the manufacturer
Date: 2024-01
DIN EN 16616/A1 (Project)
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection
Test method and requirements
Date: 2024-01
ISO/AWI 11737-1 (Project)
Sterilization of health care products - Microbiological methods
Part 1: Determination of a population of microorganisms on products
Date: 2024-01
ISO/CD TR 18965 (Project)
Cardiac valve manufacturing risk management
Date: 2024-01
DIN EN ISO 13402 (Draft)
Surgical and dental hand instruments
Determination of resistance against autoclaving, corrosion and thermal exposure
Date: 2024-01
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