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Position: Chinese Standard in English/YY/T 2001-2026
YY/T 2001-2026   (English)
Standard No.: YY/T 2001-2026 Status:to be valid remind me the status change

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Target Language:English File Format:PDF
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Standard No.: YY/T 2001-2026
Chinese Name: 体外诊断检验系统 定性检测试剂企业参考品设置要求
Professional Classification: YY    Professional Standard - Pharmaceutics
Source Content Issued by: National Medical Products Adminstration
Issued on: 2026-03-09
Implemented on: 2027-3-1
Status: to be valid
Target Language: English
File Format: PDF
本文件规定了定性检测体外诊断试剂企业参考品的通用要求以及具体阳性参考品设置、阴性参考品设置、检出限参考品设置、精密度参考品设置。
本文件适用于定性检测体外诊断试剂产品质量控制用企业参考品的设置。
本文件不适用于微生物鉴别或药敏试验的试剂及用于细胞选择、诱导、分化的细胞培养基等。
Code of China
Standard
YY/T 2001-2026   (English Version)
Standard No.YY/T 2001-2026
Statusto be valid
LanguageEnglish
File FormatPDF
Word Count words
Price(USD)
Implemented on2027-3-1
Deliveryvia email in business day
Detail of YY/T 2001-2026
Standard No.
YY/T 2001-2026
English Name
Chinese Name
体外诊断检验系统 定性检测试剂企业参考品设置要求
Chinese Classification
Professional Classification
YY
ICS Classification
Issued by
National Medical Products Adminstration
Issued on
2026-03-09
Implemented on
2027-3-1
Status
to be valid
Superseded by
Superseded on
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
words
Price(USD)
Keywords
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Introduction of YY/T 2001-2026
本文件规定了定性检测体外诊断试剂企业参考品的通用要求以及具体阳性参考品设置、阴性参考品设置、检出限参考品设置、精密度参考品设置。
本文件适用于定性检测体外诊断试剂产品质量控制用企业参考品的设置。
本文件不适用于微生物鉴别或药敏试验的试剂及用于细胞选择、诱导、分化的细胞培养基等。
Contents of YY/T 2001-2026
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Keywords:
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