GB 18278-2000
Replaced
YY/T 0615.1-2007
Active
Industry standards-Medicine
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
Basic Information
Standard Code:
YY/T 0615.1-2007
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2007-07-02
Implement Date:
2008-03-01
Pages:
6 pages
Scope
This part of YY/T 0615 specifies the requirements for marking "sterile" final sterilized medical devices. Part 2 of YY/T 0615 specifies the requirements for marking "sterile" sterile-processed medical devices. Note: Medical devices can only be marked "sterile" after using a validated sterilization process. GB 18278, GB 18279, GB 18280, GB/T 19974, and ISO 14160 specify the requirements for validation and routine control of medical device sterilization.
Development Information
Same series standard
Referenced Standards
Adopt standards
EN 556-1:2001
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