GB 8662-1988
Replaced
YY 0333-2010
Active
Industry standards-Medicine
YY 0333-2010 Soft-tissue expander device
YY 0333-2010 Soft-tissue expander device
Basic Information
Standard Code:
YY 0333-2010
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Surgical instruments and materials
Publish Date:
2010-12-27
Implement Date:
2012-06-01
Pages:
10 pages
Scope
This standard applies to single-use saline-filled soft tissue expanders used in surgery or removed within 6 months after implantation.
This standard only applies to soft tissue expanders made of elastic casings, and does not include any custom-made soft tissue expanders produced according to other standards.
For the "expander/breast" combination device, this standard applies (see also 4.3).
Development Information
Replace the following standards
Referenced Standards
GB/T 528-1998 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties
GB 15811-2001 Sterile hypodermic needles for single use
GB 15811-2016 Sterile hypodermic needles for single use
YY 0334-2002 General specification for surgical implants made of silicone elastomer
YY/T 0334-2022 General specification for surgical implants made of silicone elastomer
YY 0647-2008 Non-active surgical implants—Mammary implants—Particular requirements
YY/T 0647-2021 Non-active surgical implants—Particular requirements of mammary implants
GB 15811-2025 Sterile hypodermic needles for single use
Adopt standards
ASTM F 1441-2003
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced