GB 18278-2000
Replaced
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
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
Same series standard
Replace the following standards
Referenced Standards
Adopt standards
ISO 17664-1:2021
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced