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 10524-1 AMD 1 (Standard)
Pressure regulators for use with medical gases
Part 1: Pressure regulators and pressure regulators with flow-metering devices
Date: 2023-10
DIN EN ISO 13004 (Standard)
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose
Method VDₘₐₓSD
Date: 2023-10
DIN CEN ISO/TS 11137-4 (Pre-Standard)
Sterilisation of healthcare products - Radiation
Part 4: Guidance on process control
Date: 2023-10
DIN EN ISO 24072 (Standard)
Aerosol bacterial retention test method for air-inlet filter on administration devices
Date: 2023-10
DIN EN ISO 10651-4 (Standard)
Lung ventilators
Part 4: Particular requirements for user-powered resuscitators
Date: 2023-10
ISO 7101 (Standard)
Healthcare organization management - Management systems for quality in healthcare organizations
Requirements
Date: 2023-10
ISO 4865-1 (Standard)
Dentistry - General requirements of hand instruments
Part 1: Non-hinged hand instruments
Date: 2023-10
ISO 8549-2 (Standard)
Prosthetics and orthotics- Vocabulary
Part 2: Terms relating to external limb prostheses
Date: 2023-10
ISO 9584 (Standard)
Surgical implants - Non-destructive testing
Radiographic examination of cast metallic surgical implants
Date: 2023-10
DIN EN ISO 9342-1 (Standard)
Prothetik und Orthetik – Vokabular
Part 1: Reference lenses for focimeters used for measuring spectacle lenses
Date: 2023-10
ISO/AWI 11607-3 (Project)
Packaging for terminally sterilized medical devices
Part 3: Requirements for process development for forming, sealing and assembly
Date: 2023-10
ISO/AWI 17191 (Project)
Urine-absorbing aids for incontinence
Measurement of airborne respirable polyacrylate superabsorbent materials - Determination of dust in collection cassettes by sodium atomic absorption spectrometry
Date: 2023-10
DIN EN ISO 11199-2/A1 (Project)
Assistive products for walking manipulated by both arms - Requirements and test methods
Part 2: Rollators
Date: 2023-10
ISO/AWI 80601-2-94 (Project)
Medical electrical equipment
Part 2-94: Particular requirements for basic safety and essential performance of inhalational therapy nebulizer equipment
Date: 2023-10
IEC/AWI 80369-5 (Project)
Small-bore connectors for liquids and gases in healthcare applications
Part 5: Connectors for limb cuff inflation applications
Date: 2023-10
DIN EN ISO 22112 rev (Project)
Dentistry - General requirements of hand instruments
Artificial teeth for dental prostheses
Date: 2023-10
ISO/CD TR 9241-313 (Project)
Ergonomics of human-system interaction
Part 313: Optical measurement method for reflective displays
Date: 2023-10
DIN EN 14683 (Draft)
Medical face masks
Requirements and test methods
Date: 2023-10
DIN EN ISO 8362-2 (Draft)
Injection containers and accessories
Part 2: Closures for injection vials
Date: 2023-10
DIN EN ISO 14889 (Draft)
Ophthalmic optics - Spectacle lenses
Fundamental requirements for uncut finished lenses
Date: 2023-10
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