GB 8662-1988
Replaced
YY/T 1980-2025
Pending
Industry standards-Medicine
YY/T 1980-2025 Sterile wound protector for single use
YY/T 1980-2025 Sterile wound protector for single use
Basic Information
Standard Code:
YY/T 1980-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Surgical instruments and materials
Publish Date:
2025-06-18
Implement Date:
2026-07-01
Pages:
20 pages
Scope
This document specifies the classification and marking, materials, requirements, labels and instructions, packaging, transportation, and storage of single-use sterile incision protection sleeves (hereinafter referred to as "incision protection sleeves"), and describes the corresponding test methods.
This document is applicable to incision protection sleeves that play a role in fixing, retracting, dilating, and isolating contamination at endoscopic or open surgical incision sites.
This document is not applicable to single-use endoscopic protection sleeves.
Development Information
Referenced Standards
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
中华人民共和国药典(2020年版
四部)
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