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:
IEC 80001-1 PRV (standard)
Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Part 1: Application of risk management
Date: 2021-02-12
ISO 17664-2:2021 (standard)
Processing of health care products
Information to be provided by the medical device manufacturer for the processing of medical devices
Part 2: Non-critical medical devices
Date: 2021-02
ISO/TR 11633-2 (Standard)
Health informatics
Information security management for remote maintenance of medical devices and medical information systems
Part 2: Implementation of an information security management system (ISMS)
Date: 2021-02
DIN EN ISO 1942 (Standard)
Dentistry
Vocabulary
Date: 2021-02
DIN EN ISO 17730 (standard)
Dentistry
Fluoride varnishes
Date: 2021-02
DIN EN ISO 10477 (standard)
Dentistry
Polymer-based crown and veneering materials
Date: 2021-02
DIN EN 17406 (standard)
Use classification of bicycles
Date: 2021-02
ISO 17420-1 (standard)
Respiratory protective devices
Performance requirements
Part 1: General
Date: 2021-01
ISO 10993-12 (Standard)
Biological evaluation of medical devices
Part 12: Sample preparation and reference materials
Date: 2021-01
ISO/TS 22421 (Standard)
Sterilization of health care products
Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Date: 2021-01
ISO 10993-23 (Standard)
Biological evaluation of medical devices
Part 23: Tests for irritation
Date: 2021-01
ISO/AWI 15193 (Project)
In vitro diagnostic medical devices
Measurement of quantities in samples of biological origin
Requirements for the content and presentation of reference measurement methods
Date: 2021-02-26
ISO/AWI 15194 (Project)
In vitro diagnostic medical devices
Measurement of quantities in samples of biological origin
Requirements for certified reference materials and for the content of the accompanying documentation
Date: 2021-02-26
DIN EN ISO 14155 (Project)
Clinical testing of medical devices on humans
Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
Date: 2021-02-18
ISO/AWI TR7015 (Project)
Ergonomics
Informative Application Document for International Standards
Date: 2021-02-03
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 forces of the human body
Part 5: Maximum static action forces, values
Date: 2021-01-25
DIN EN ISO 27427 (Project)
Anaesthetic and respiratory equipment
Nebulizing systems and components
Date: 2021-01-13
ISO/DIS 23417 (Project)
General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
Date: —
ISO/CD 10993-17.2 (Project)
Biological evaluation of medical devices
Part 17: Toxicological risk assessment of medical device constituents
Date: —
ISO/FDIS 10993-10 (Project)
Biological evaluation of medical devices
Part 10: Tests for skin sensitization
Date: —
ISO/CD 7176-31 (Project)
Wheelchairs
Part 31: Lithium-based battery technology
Date: —
ISO/DIS 7176-14 (Project)
Wheelchairs
Part 14: Power and control systems for electrically powered wheelchairs and scooters — Requirements and test methods
Date: —
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