New Standards and Standards Projects in October 2023

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


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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