YY/T 0802.1-2024 Active Industry standards-Medicine

YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices

YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0802.1-2024
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Public medical equipment
ICS Name: Integrated disinfection and sterilization
Publish Date: 2024-09-29
Implement Date: 2025-10-15
Pages: 23 pages

Scope

This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of highly dangerous medical devices (i.e., medical devices that enter the normal sterile parts of the human body, or medical devices that come into contact with mucous membranes or incomplete skin) or medical devices prepared for sterilization.
This document applies to the information provided for the handling of medical devices before they are used or reused.

Development Information

Word Count: 38 Thousand words Pages: 23 pages

Same series standard

Replace the following standards

Referenced Standards

Adopt standards

ISO 17664-1:2021

Related Standards

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