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:
DIN EN ISO 21917 (standard)
Anaesthetic and respiratory equipment
Voice prosthesis
Date: 2023-02
ISO/TR 10993-55 (standard)
Biological evaluation of medical devices
Part 55: Interlaboratory study on cytotoxicity
Date: 2023-02
IEC 60601-2-2:2017+AMD1 (standard)
Medical electrical equipment
Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Date: 2023-02
ISO 16976-6 (standard)
Respiratory protective devices - Human factors
Part 6: Psychological and physiological effects
Date: 2023-02
ISO 16976-4 (standard)
Respiratory protective devices - Human factors
Part 4: Breathing work and breathing resistance: physiologically founded maximum values
Date: 2023-02
ISO 16976-8 (standard)
Respiratory protective devices - Human factors
Part 8: Ergonomic factors
Date: 2023-02
DIN EN ISO 10993-2 (standard)
Biological evaluation of medical devices
Part 2: Animal welfare regulations
Date: 2023-02
DIN EN ISO 8872 (standard)
Aluminium and aluminium/plastic caps for infusion and injection bottles
General requirements and test methods
Date: 2023-02
ISO 10282 (standard)
Sterile surgical gloves made of rubber for single use
Specification
Date: 2023-02
DIN EN ISO 80369-3 (standard)
Small-bore connectors for liquids and gases in healthcare applications
Part 3: Connectors for enteral applications
Date: 2023-02
DIN EN ISO 11140-6 (standard)
Sterilisation of healthcare products - Chemical indicators
Part 6: Class 2 indicators and samples for performance testing of small steam sterilisers
Date: 2023-02
DIN EN ISO 13119 (standard)
Medical Informatics - Clinical Knowledge Resources - Metadata
Date: 2023-02
DIN EN ISO 13131 (standard)
Medical informatics - Telemedical services
Quality planning guidelines
Date: 2023-02
DIN EN IEC 80001-1; VDE 0756-1 (standard)
Application of risk management for IT networks containing medical devices
Part 1: Safety, effectiveness, data and system security in the implementation and use of integrated medical devices or integrated healthcare software
Date: 2023-02
DIN EN ISO 5362 (Draft)
Anaesthesia and respiratory equipment - Anaesthesia reservoir bags
Date: 2023-02
DIN EN 556-2 (Draft)
Sterilisation of medical devices - Requirements for medical devices labelled as "STERILE"
Part 2: Requirements for aseptically manufactured medical devices
Date: 2023-02
DIN EN 556-2 (Draft)
Sterilisation of medical devices - Requirements for medical devices labelled as "STERILE"
Part 1: Requirements for medical devices sterilised in the final packaging
Date: 2023-02
DIN EN ISO 15621 rev (Project)
Absorbent incontinence aids for urine and/or faeces
General guidelines for the evaluation
Date: 2023-02-20
ISO/IEC CD TR 18720 (Project)
Information technology – User interfaces – Use cases of serviced offices
Date: 2023-02-14
DIN EN ISO 18969 (Project)
Clinical evaluation of medical devices
Date: 2023-02-22
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