Dịch thuật y khoa là một phần không thể thiếu trong ngành y tế, vì nó trực tiếp ảnh hưởng đến sự an toàn của bệnh nhân và hiệu quả điều trị. Để đảm bảo độ chính xác và chuyên nghiệp cao nhất, dịch vụ dịch thuật y khoa cần đáp ứng các tiêu chuẩn nhất định. Dưới đây là những tiêu chuẩn quan trọng mà mọi dịch vụ dịch thuật y khoa cần phải tuân thủ.

One of the most important standards in medical translation is ISO 17100, an international standard that outlines the requirements for the translation process. This standard ensures that medical translations are carried out by qualified professionals with expertise in language, specialized knowledge, and experience. ISO 17100 also mandates that the translation process includes quality control measures and proofreading to ensure the accuracy and precision of the final translation. Adherence to ISO 17100 is essential to maintaining the quality of medical translation services.

For translations involving medical device documentation, compliance with ISO 13485 is crucial. ISO 13485 specifies the requirements for a quality management system in the design and manufacturing of medical devices. This standard ensures that translations related to medical devices, such as user manuals, safety instructions, and technical specifications, are accurate and comply with the safety regulations of the target markets. Compliance with ISO 13485 helps medical device manufacturers protect their reputation and ensure product quality when exporting globally.

ISO 9001 is an international standard for quality management systems. This standard ensures that the translation company follows a stringent quality control process at every stage of the translation work. Compliance with ISO 9001 guarantees stable service quality, meets client requirements, and continuously improves the translation process. This is particularly important in medical translation, where accuracy and high-quality standards are non-negotiable.

When translating documents related to medical devices, ISO 14971 is the risk management standard that translation services need to understand. Although not directly related to translation, when translating documents concerning medical devices, translators and translation companies need to be aware of the risk management requirements and regulations. This ensures that the translations meet regulatory agency standards and helps minimize errors that could pose risks to users of medical devices.

With the rise of technology and the shift towards electronic health records, ISO 13606 is an indispensable standard for translating electronic medical documents. For medical translation involving electronic patient records and digital health documents, compliance with ISO 13606 ensures that the translations are not only accurate but also comply with security and privacy regulations regarding medical data.

In addition to international standards, medical translation services must also comply with the legal requirements of individual countries. For example, in the United States, medical documents must meet the FDA (Food and Drug Administration) requirements, while in Europe, the Medical Device Regulation (MDR) imposes specific language and presentation guidelines. This requires translators to not only be proficient in medical terminology but also have a deep understanding of local laws and culture.

Furthermore, accuracy in medical translation goes beyond using the correct terminology—it requires the ability to convey meaning clearly and understandably for the intended audience. Modern technologies, such as artificial intelligence (AI) and machine learning (ML), have become powerful tools in optimizing the speed and accuracy of translations. However, the human factor remains central, as only professional translators can capture the nuances of meaning and ensure cultural appropriateness.

Tại innoword, chúng tôi hiểu rằng dịch thuật y khoa không chỉ là công việc ngôn ngữ mà còn là trách nhiệm đối với sức khỏe cộng đồng. Chúng tôi tuân thủ nghiêm ngặt các tiêu chuẩn quốc tế và tận dụng công nghệ tiên tiến để mang đến những bản dịch chất lượng cao, đồng thời luôn đặt yếu tố chuyên môn và đạo đức nghề nghiệp lên hàng đầu. Liên hệ với chúng tôi ngay hôm nay để nhận báo giá miễn phí!