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 16628 (Standard)
Anesthesia and respiratory equipment - Tracheobronchial tubes
Date: 2022-06
DIN EN ISO 4135 (Standard)
Anesthesia and respiratory equipment - Terms
Date: 2022-06
DIN EN ISO 10079-4 (Standard)
Medical Suction Devices
Part 4: General requirements
Date: 2022-06
DIN EN IEC 80601-2-26 Corrigendum 1; VDE 0750-2-26 Corrigendum 1 (Standard)
Medical Electrical Equipment
Part 2-26: Particular requirements for the safety, including essential performance, of electroencephalographs
Date: 2022-06
DIN EN IEC 60601-2-35-100; VDE 0750-2-35-100 (Draft)
Medical Electrical Equipment
Part 2-35: Particular requirements for the safety, including essential performance, of blankets, mats and mattresses for patient warming in medical use
Date: 2022-06
DIN EN IEC 80601-2-49/A1; VDE 0750-2-49/A1 (Draft)
Medical Electrical Equipment
Part 2-49: Particular requirements for the safety, including essential performance, of multifunctional patient monitoring devices
Date: 2022-06
DIN EN ISO 80601-2-72 (Draft)
Medical Electrical Equipment
Part 2-72: Particular requirements for the safety, including essential performance, of home ventilation equipment for device-dependent patients
Date: 2022-06
DIN EN ISO 11607-2/A11 (Project)
Packaging for terminally sterilized medical devices
Part 2: Validation requirements for forming, sealing and assembling processes
Date: 2022-06-03
DIN EN ISO 11607-1/A11 (Project)
Packaging for terminally sterilized medical devices
Part 1: Requirements for materials, sterile barrier systems and packaging systems
Date: 2022-06-03
DIN EN 556-1 rev (Project)
Sterilization of medical devices - Requirements for medical devices marked as "STERILE"
Part 1: Requirements for medical devices sterilized in the final pack
Date: 2022-06-07
DIN EN 556-2 rev (Project)
Sterilization of medical devices - Requirements for medical devices marked as "STERILE"
Part 2: Requirements for aseptically manufactured medical devices
Date: 2022-06-07
DIN EN ISO 8250 (Project)
Purity of medical devices
Process design and test procedures
Date: 2022-06-07
DIN CEN ISO/TR 9241-514 (Project)
Ergonomics of human-system interaction
Part 514: Guidelines for the application of anthropometric data in the ISO 9241-500 series
Date: 2022-06-23
DIN EN 50419 (Project)
Labeling of electrical and electronic equipment for separate collection of waste electrical and electronic equipment
Date: 2022-06-29
DIN EN ISO 21917 (Project)
Anesthesia and respiratory equipment. Voice prostheses
Date: 2022-06-29
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