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New Standards and Standard Projects in February 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/AWI 15193 (Project)

In vitro diagnostic medical devices

Measurement of quantities in samples of biological origin – Requirements for content and presentation of reference measurement procedures

Date: 2021-02-26

ISO/AWI 15194 (Project)

DIn vitro diagnostic medical devices

Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation

Date: 2021-02-26

DIN EN ISO 14155 (Project)

Clinical investigation of medical devices for human subjects

Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

Date: 2021-02-18

IEC 80001-1 (PRV)

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

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

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

Dentistry

Vocabulary

Date: 2021-02

DIN EN ISO 17730

Dentistry

Fluoride varnishes

Date: 2021-02

DIN EN ISO 10477

Dentistry

Polymer based crown and veneering materials

Date: 2021-02

ISO/AWI TR7015 (Project)

Ergonomics

Informative Application Document for International Standards

Date: 2021-02-03

DIN EN 17406

Classification for bicycles usage

Date: 2021-02

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

Datem:

 

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