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 10993-7 (Standard)
Biological evaluation of medical devices
Part 7: Ethylene oxide sterilization residuals
Date: 2026-04
ISO 11608-1 AMD 1 (Standard)
Needle-based injection systems for medical use
Requirements and test methods – Part 1: Needle-based injection systems – AMENDMENT 1
Date: 2026-04
ISO 80601-2-61 (Standard)
Medical Electrical Equipment
Part 2-61: Particular requirements for the safety, including essential performance, of pulse oximeters
Editor’s note: CHANGES ALSO IN PARTS 2-67, 2-70 AND 2-90
Date: 2026-04
ISO 12312-1 AMD 1 (Standard)
Eye and face protection
Sunglasses and similar eye protection – Part 1: Sunglasses for general use – Amendment 1
Date: 2026-04
DIN EN ISO 11986 (Standard)
Ophthalmic optics
Contact lenses and contact lens care products – Determination of the uptake and release of preservatives (ISO 11986:2026); German version of EN ISO 11986:2026
Date: 2026-04
DIN EN ISO 11737-1 (Draft)
Sterilization of health care products
Sterilisation of healthcare products – Microbiological methods – Part 1: Determination of the population of microorganisms on products (ISO/DIS 11737-1:2026); German and English versions of prEN ISO 11737-1:2026
Date: 2026-04
DIN EN ISO 29022 (Draft)
Dentistry
Adhesion – Testing of shear bond strength using a notched blade (ISO/DIS 29022:2026); German and English versions of prEN ISO 29022:2026
Date: 2026-04
DIN ISO 10110-6 (Draft)
Optics and photonics
Preparation of drawings for optical elements and systems – Part 6: Centring and tilt tolerances (ISO 10110-6:2025); text in German and English
Date: 2026-04
DIN EN ISO 13408-4 rev (Project)
Aseptic processing of health care products
Part 4: Cleaning processes for surfaces used within a critical processing zone
Date: 2026-04-17
DIN EN ISO 3630-4 rev (Project)
Dentistry
Endodontic instruments - Part 4: Auxiliary instruments
Date: 2026-04-08
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