[Usability and standards of medical devices]

Liu Xin1

  • 1Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, 200021. liuxin@smda.gov.cn

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Standards of Care I01:22

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Standard Precaution01:26

Standard Precaution

Standard precautions are the minimum infection control safeguards used while caring for all patients, irrespective of their disease condition. They help prevent the spread of common infectious microorganisms to healthcare workers, patients, and visitors in all healthcare settings.
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Good Manufacturing Practices01:26

Good Manufacturing Practices

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...
Standards of Care II01:19

Standards of Care II

Nurses bear specific legal responsibilities under several federal statutes, including:
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Guidelines for Nursing Documentation I01:30

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Quality documentation and reporting share essential characteristics that ensure they are practical and valuable resources for those who use them. These characteristics are:
Factual:  
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