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 80601-2-55 AMD 1 (Standard)
Medical Electrical Equipment
Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase
Date: 2023-12
DIN EN ISO 80601-2-72 (Standard)
Medical Electrical Equipment
Teil 2-72: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom Gerät abhängige Patienten
Date: 2023-12
DIN EN ISO 27427 (Standard)
Anaesthetic and respiratory equipment
Nebulizing systems and components
Date: 2023-12
DIN EN ISO 5367 (Standard)
Anaesthetic and Respiratory Equipment
Breathing sets and connectors
Date: 2023-12
DIN EN 13726 (Standard)
Test methods for wound dressings
Aspects of absorption, moisture vapour transmission, waterproofness and extensibility
Date: 2023-12
DIN EN ISO 3630-4 (Standard)
Zahnheilkunde – Wurzelkanalinstrumente
Teil 4: Hilfsinstrumente
Date: 2023-12
IEC 60601-2-35:2020+AMD1:2023 CSV (Consolidated Version) (Norm)
Medical Electrical Equipment
Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
Date: 2023-12
DIN EN ISO 8536-5 rev (Project)
Infusion equipment for medical use
Part 5: Burette infusion sets for single use, gravity feed
Date: 2023-12
DIN EN ISO 11616 rev (Project)
Health informatics - Identification of medicinal products
Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Date: 2023-12
DIN EN ISO 11615 rev (Project)
Health informatics - Identification of medicinal products
Data elements and structures for the unique identification and exchange of regulated medicinal product information
Date: 2023-12
DIN EN ISO 11238 rev (Project)
Health informatics - Identification of medicinal products
Data elements and structures for the unique identification and exchange of regulated information on substances
Date: 2023-12
DIN EN ISO 17117-1 rev (Project)
Health informatics - Terminological resources
Part 1: Characteristics
Date: 2023-12
ISO/CD 20417 (Project)
Medical Devices
Information to be supplied by the manufacturer
Date: 2023-12
DIN 32983 (Project)
Lifts installed on vehicles for wheelchairusers and for people restricted in their mobility
Additional safety requirements and testing
Date: 2023-12
ISO 7176-14 AMD 1 (Project)
Wheelchairs
Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
Date: 2023-12
ISO 7176-25 AMD 1 (Project)
Wheelchairs
Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
Date: 2023-12
DIN EN ISO 13504 rev (Project)
Dentistry
General requirements for instruments and related accessories used in dental implant placement and treatment
Date: 2023-12
DIN EN ISO 11810/A11 (Project)
Lasers and laser-related equipment
Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition
Date: 2023-12
ISO/CD 7554-1 (Project)
Surgical instruments - Terms, measuring methods and tests
Part 1: Vocabulary
Date: 2023-12
ISO/CD 7554-3 (Project)
Surgical instruments - Terms, measuring methods and tests
Part 2: Measuring methods for the determination of basic measures of surgical standard instruments
Date: 2023-12
ISO/CD 7554-3 (Project)
Surgical instruments - Terms, measuring methods and tests
Part 3: Test methods
Date: 2023-12
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