New Standards and Standard Projects in January 2021

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/IEC CD 29138-3 (Project)

Information technology

Accessibility considerations for people with disabilities
Part 3: Guidance on user needs mapping

Date: 2021-01-28

DIN 33411-5 (Project)

Physical strength of man

Part 5: Maximal isometric action forces, values

Date: 2021-01-25

DIN EN ISO 27427 (Project)

Anaesthetic and respiratory equipment

Nebulising systems and components

Date: 2021-01-13

ISO 17420-1

Respiratory protective devices

Performance requirements
Part 1: General

Date: 2021-01

ISO 10993-12

Biological evaluation of medical devices

Part 12: Sample preparation and reference materials

Date: 2021-01

ISO/TS 22421

Sterilization of health care products

Common requirements for sterilisers for terminal sterilization of medical devices in health care facilities

Date: 2021-01

ISO 10993-23

Biological evaluation of medical devices

Part 23: Tests for irritation

Date: 2021-01

DIN EN ISO 10651-5 (Project)

Lung ventilators for medical use

Particular requirements for basic safety and essential performance
Part 5: Gas-powered emergency resuscitators

Date: 2021-01-04

DIN EN ISO 11073-10101

Health informatics

Device interoperability
Part 10101: Point-of-care medical device communication – Nomenclature

Date: 2021-01

DIN EN ISO 28399 (Draft)


External tooth bleaching products

Date: 2021-01

DIN 33402-2


Human body dimensions
Part 2: Values

Date: 2020-12

ISO 9241-971

Ergonomics of human-system interaction

Part 971: Accessibility of tactile/haptic interactive systems

Date: 2020-12

DIN EN 10942 rev (Project)

Ophthalmic instruments

Direct ophthalmoscopes

Date: 2020-12-21


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