关键词: 毒理检测领域, 认可机构, 认可能力范围表述, 动物实验

Abstract:

With the series of regulations issued by the State Administration for Market Regulation entitled "Release, Regulation, and Service" and the rapid development of the biomedical health industry, the demand for toxicology testing is increasing, and the number of testing institutions is also growing. Statements of accreditation capacity scope of toxicology laboratories must also be more specialized and international. In this paper, the project classification, detection objects, items/parameters, statements of accreditation and scope of the Chinese regulatory toxicology testing field were described. The accreditation capacity scope of 4 mainstream international accreditation institutions in the field of toxicology testing, in New Zealand, the United States, Japan, and the United Kingdom, was organized and analyzed. Results showed that China, New Zealand and other countries mentioned above used the same basic expression regarding the scope of accreditation capacity in the field of toxicology testing; these expressions covered detection objects, detection methods/technologies, detection standards and field codes, but their classification principles for codes varied slightly. In order to standardize and uniformly express the scope of accreditation capacity in this field and improve the professional level of laboratories, this study puts forth suggestions on detection objects, items/parameters, field codes, names(method)and numbers(including year numbers) of detection standards, and the scope of limitations.

Key words: Field of toxicology testing, Authorized institution, Expression scope of accreditation, Animal experiments