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:
DIN EN ISO 13485 (Standard)
Medical Devices
Quality management systems - requirements for regulatory purposes
Date: 2021-12
DIN EN 60601-1-11 (Standard)
Medical Electrical Equipment
Part 1-11: Particular requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems for medical care in the home environment
Date: 2021-12
DIN EN 60601-1-2 (Standard)
Medical Electrical Equipment
Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Date: 2022-01
DIN EN ISO 80601-2-85 (Standard)
Medical Electrical Equipment
Part 2-85: Particular requirements for the safety, including essential performance, of cerebral oximetry equipment
Date: 2022-01
ISO 15798:2022 (Standard)
Ophthalmological implants
Ophthalmologische viskochirurgische Geräte
Date: 2022-01
ISO 25424:2018/Amd 1:2022 (Standard)
Sterilization of health care products
Low temperature steam and formaldehyde - Requirements for the development, validation and routine control of a sterilisation process for medical devices - Amendment 1
Date: 2022-01
IEC 60751:2022 (Standard)
Industrial platinum resistance thermometers and platinum temperature sensors
Date: 2022-01
Read more about:
- Normen und Normen-Projekte aus November 2021
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