GB 18278-2000
Replaced
YY/T 0802.2-2024
Active
Industry standards-Medicine
YY/T 0802.2-2024 Processing of medical device—Information to be provided by the medical device manufacturer—Part 2:Non-critical medical devices
YY/T 0802.2-2024 Processing of medical device—Information to be provided by the medical device manufacturer—Part 2:Non-critical medical devices
Basic Information
Standard Code:
YY/T 0802.2-2024
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:
22 pages
Scope
This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of low-risk medical devices (i.e., medical devices that only come into contact with intact skin or medical devices that do not directly contact patients).
This document applies to the information required for handling medical devices before they are used or reused.
Development Information
Same series standard
Replace the following standards
Referenced Standards
Adopt standards
ISO 17664-2:2021
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