What is ISO/TR 9241-305:2016 ?

What is ISO/TR 9241-305:2016 and EN ISO 11682-1:2016?

ISO/TR 9241-305:2016 is a technical standard that outlines the requirements for safety-related control systems in machinery. It is designed to ensure the safety of workers, customers, and the environment through the proper management of machinery risks.

EN ISO 11682-1:2016 is a professional technical standard that focuses on the safety of machinery and equipment. It provides guidelines and requirements for the design, construction, and operation of machinery to promote safety in various industries.

EN ISO 11682-1:2016 aims to minimize potential hazards and risks associated with the use of machinery, including mechanical, electrical, and thermal dangers. By complying with this standard, manufacturers can create safer products, and organizations can implement proper safety protocols to protect their employees.

EN ISO 11608-1:2016 is a technical standard that provides guidelines for the design and testing of autoinjectors for medical use. It ensures the safety, reliability, and quality of autoinjectors, recognized worldwide.

Key Requirements of EN ISO 11682-1:2016

EN ISO 11682-1:2016 has several key requirements that manufacturers must meet to ensure the safety and quality of their products. These requirements include:

Medical device regulations: The device must be designed, manufactured, and validated in accordance with medical device regulations, including 21 CFR Part 807.

Design requirements: The device must be designed to minimize the risk of mechanical, electrical, or thermal hazards to users, including proper labeling, warning, and instructions.

Test requirements: The device must undergo various tests, including a performance test, a reliability test, and a user test, to ensure its safety and reliability.

Documentation requirements: The device must be thoroughly documented to include a user manual, a maintenance manual, and a batch record, among others.

Traceability requirements: The device must be traceable from the design stage to the final product, including documentation of the design, testing, and validation.

By complying with these key requirements, manufacturers can ensure the safety and quality of their products, and organizations can protect their employees from potential hazards associated with the use of machinery.