GB 9706.5-1992
Replaced
YY/T 0969-2023
Active
Industry standards-Medicine
YY/T 0969-2023 Single-use medical face mask
YY/T 0969-2023 Single-use medical face mask
Basic Information
Standard Code:
YY/T 0969-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Hospital equipment
Publish Date:
2023-11-22
Implement Date:
2025-12-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用防护器械标准化工作组(SAC/SWG 30)
Pages:
8 pages
Scope
本文件规定了一次性使用医用口罩的技术要求，试验方法，标志，包装、运输和贮存。
本文件适用于覆盖使用者口、鼻及下颌，用于普通医疗环境中佩戴、阻隔口腔和鼻腔呼出或喷出污染物的一次性使用口罩。
本文件不适用于医用防护口罩、医用外科口罩。
Development Information
Drafting Units:
北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、广东省医疗器械质量监督检验所、新疆维吾尔自治区药品检验研究院(新疆维吾尔自治区医疗器械检验检测中心)、北京化工大学、江西3L医用制品集团股份有限公司、亚都控股集团有限公司、稳健医疗用品股份有限公司、振德医疗用品股份有限公司、奥美医疗用品股份有限公司、宁波市康家乐医疗器械有限公司
Drafting Persons:
刘思敏、罗庆祥、孙鹏、王丹、童晓凤、刘明宇、杨小孟、陈明、曹孟杰、黄丽豪、刘克洋、黄永富、张亚萍、赵丹、李华、张娟、李剑、李悦菱、胡广勇
Replace the following standards
Referenced Standards
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
中华人民共和国药典 2020年版 四部
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
YY 0469-2004 Technical requirements for surgical mask
YY 0469-2011 Surgical mask
YY 0469-2023 Surgical mask
Related Standards
GB 9706.6-1992
Replaced
GB 9706.6-1992 Particular requirements for the safety of microwave therapy equipment
GB/T 14710-1993
Replaced
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB 9706.7-1994
Replaced
GB 9706.7-1994 Medical electrical equipment—Particular requirements for the safety of ultrasonic therapy equipment
GB 12130-1995
Replaced
GB 12130-1995 Medical hyperbaric oxygen chamber
GB 9706.1-1995
Replaced