医疗器械留样管理 Management of Medical Device Sample Retention

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[color=var(--md-box-samantha-deep-text-color) !important]留样目的

• 质量验证：用于后续产品性能检测、稳定性测试或投诉调查。
• 追溯依据：在产品出现质量问题时，通过留样分析定位原因。
• 合规备查：满足监管机构（如药监局）飞行检查或企业内部审计需求.
  

Purpose of sample retention
Quality verification: used for subsequent product performance testing, stability testing, or complaint investigation.
Traceability basis: When quality problems occur in the product, the root cause is identified through sample analysis.
Compliance record keeping: Meet the flight inspection or internal audit needs of regulatory agencies (such as the Drug Administration)

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[color=var(--md-box-samantha-deep-text-color) !important]留样范围

• 产品类型：覆盖所有生产批次的医疗器械（包括最终成品、关键组件或原材料）。
• 特殊情况：无菌 / 植入类等高风险产品需增加留样比例。
  

Scope of sample retention
Product type: Medical devices covering all production batches (including final products, critical components, or raw materials).
Special circumstances: High risk products such as sterile/implantable products require an increase in sample retention ratio.

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[color=var(--md-box-samantha-deep-text-color) !important]留样数量

• 常规留样：通常为生产批次数量的 1%-3%，至少保留 3 个独立包装。
• 稳定性试验：需按《中国药典》或行业标准要求，留存足够数量以完成长期监测。
  

Quantity of retained samples
Regular sample retention: usually 1% -3% of the production batch quantity, with at least 3 independent packages retained.
Stability test: Sufficient quantities must be retained according to the requirements of the Chinese Pharmacopoeia or industry standards to complete long-term monitoring.

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[color=var(--md-box-samantha-deep-text-color) !important]保存条件

• 环境控制：温湿度需符合产品说明书要求（如阴凉库 2-8℃、常温库 10-30℃）。
• 标识清晰：注明产品名称、批次号、生产日期、留样日期及保存期限。
  

storage condition
Environmental control: The temperature and humidity should meet the requirements of the product manual (such as 2-8 ℃ for cool storage and 10-30 ℃ for room temperature storage).
Clear identification: indicate the product name, batch number, production date, sample retention date, and shelf life.

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[color=var(--md-box-samantha-deep-text-color) !important]保存期限

• 一般产品：至少保存至有效期后 1 年（如产品有效期 2 年，则留样需保存 3 年）。
• 无菌 / 植入类：需保存至产品失效后 2 年，或根据法规要求延长。
  

Shelf life
General products: Keep for at least 1 year after the expiration date (if the product has an expiration date of 2 years, the sample needs to be kept for 3 years).
Aseptic/Implantable: Should be stored for 2 years after the product expires, or extended according to regulatory requirements.

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[color=var(--md-box-samantha-deep-text-color) !important]记录管理

• 台账登记：建立电子或纸质台账，记录留样编号、批次、数量、保存位置及状态。
• 变更追溯：如保存条件变更或留样转移，需详细记录并签字确认。
  

record management
Ledger registration: Establish an electronic or paper ledger to record the sample number, batch, quantity, storage location, and status.
Change traceability: If there are changes in storage conditions or sample transfer, detailed records and signature confirmation are required.

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• 留样抽取：
  
  
  • 生产过程中由质量部门随机抽取，确保样本具有代表性。
  • 特殊产品（如一次性使用无菌器械）需在无菌环境下抽样。
    
• Sample extraction:
• During the production process, the quality department randomly selects samples to ensure their representativeness.
• Special products (such as disposable sterile instruments) need to be sampled in a sterile environment.
  

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• 入库保存：
  
  
  • 按类别分区存放，避免交叉污染。
  • 定期检查保存条件（如温湿度记录仪校准）。
    

Storage and Preservation:
Store by category to avoid cross contamination.
Regularly check the storage conditions (such as calibration of temperature and humidity recorders).

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• 使用审批：
  
  • 如需取用留样，需经质量负责人批准，并记录用途、取用日期及剩余量。
    
• 过期处置：
  
  
  • 过期留样需按《医疗废物管理条例》销毁，双人监督并记录销毁过程。
    
• Usage approval:
• If it is necessary to take and retain samples, approval from the quality manager is required, and the purpose, date of collection, and remaining quantity must be recorded.
• Expired disposal:
• Expired samples must be destroyed in accordance with the Regulations on the Management of Medical Waste, with two people supervising and recording the destruction process.
  

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[color=var(--md-box-samantha-deep-text-color) !important]法规依据

• 中国：《医疗器械生产质量管理规范》（GMP）、《医疗器械监督管理条例》。
• 国际：ISO 13485《医疗器械质量管理体系》、FDA 21 CFR Part 820。
  

legal basis
China: Good Manufacturing Practice (GMP) for Medical Devices and Regulations on the Supervision and Administration of Medical Devices.
International: ISO 13485 "Quality Management System for Medical Devices" FDA 21 CFR Part 820。