GB/T 17995-1999
Abolished
YY/T 1833.2-2022
Active
Industry standards-Medicine
YY/T 1833.2-2022 Artificial intelligence medical device—Quality requirements and evaluation—Part 2:General requirements for datasets
YY/T 1833.2-2022 Artificial intelligence medical device—Quality requirements and evaluation—Part 2:General requirements for datasets
Basic Information
Standard Code:
YY/T 1833.2-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Other medical equipment
Publish Date:
2022-07-01
Implement Date:
2023-07-01
Publisher:
国家药品监督管理局
Technical Committee:
全国人工智能医疗器械标准化技术归口单位
Pages:
22 pages
Scope
本文件规定了人工智能医疗器械全生命周期使用的数据集的通用质量要求和评价方法。
本文件适用于人工智能医疗器械研发、生产、测试、质控等环节使用的数据集的开发与评价。
Development Information
Drafting Units:
中国食品药品检定研究院、解放军总医院、上海长征医院、中国科学院深圳先进技术研究院、华为技术有限公司、飞利浦(中国)投资有限公司、上海西门子医疗器械有限公司、杭州依图医疗技术有限公司、腾讯医疗健康(深圳)有限公司、上海联影智能医疗科技有限公司、广州柏视医疗科技有限公司、美中互利医疗有限公司、慧影医疗科技(北京)有限公司、北京安德医智科技有限公司、广州市妇女儿童医疗中心、中山大学中山眼科中心
Drafting Persons:
王浩、刘士远、何昆仑、郑海荣、李佳戈、詹翊强、孟祥峰、萧毅、葛鑫、刘东泉、颜子夜、钱天翼、丁子建、陆遥、任海萍、柴象飞、周娟、王珊珊、张培芳、梁会营、林浩添
Same series standard
Referenced Standards
GB/T 2828.4-2008 Sampling procedures for inspection by attributes—Part 4:Procedures for assessment of declared quality levels
GB/T 2828.11-2008 Sampling procedures for inspection by attributes—Part 11:Procedures for assessment of declared quality levels for small population
GB/T 6378.4-2008 Sampling procedures for inspection by variables—Part 4:Procedures for assessment of declared quality levels for mean
GB/T 6378.4-2018 Sampling procedures for inspection by variables—Part 4:Procedures for assessment of declared quality levels for mean
YY/T 1833.1-2022 Artificial intelligence medical device—Quality requirements and evaluation—Part 1:Terminology
Related Standards
GB/T 18990.1-2003
Replaced
GB/T 18990.1-2003 Luteinizing hormone(LH)test strip—Part 1:Ovulation test strip
GB/T 18990.2-2003
Replaced
GB/T 18990.2-2003 Luteinizing hormone(LH) test strip—Part 2:Sterility test strip
GB/T 18990.3-2003
Replaced
GB/T 18990.3-2003 Luteinizing hormone(LH) test strip Part 3:Contraceptive test strip
YY 0476-2004
Abolished
YY 0476-2004 Irrigating solutions for ophthalmic surgery
YY 0477-2004
Replaced