title: [Precautions of physical performance requirements and test methods during product standard drafting process of medical devices].
abstract: The major idea of this article is to discuss standardization and normalization for the product standard of medical devices. Analyze the problem related to the physical performance requirements and test methods during product standard drafting process and make corresponding suggestions.
authors.affiliation: SFDA Ji'nan Quality Supervision and Inspection Center for Medical Devices Ji'nan, Shandong. gold42@sina.com
authors.forename: Jin-Zi
authors.initials: JZ
authors.lastname: Song
authors.forename: Min
authors.initials: M
authors.lastname: Wan
authors.forename: Hui
authors.initials: H
authors.lastname: Xu
authors.forename: Xiu-Jun
authors.initials: XJ
authors.lastname: Yao
authors.forename: Bo
authors.initials: B
authors.lastname: Zhang
authors.forename: Jin-Hong
authors.initials: JH
authors.lastname: Wang
mesh_terms: D018795:Device Approval; D004864:Equipment and Supplies / Q000592:standards*; D008422:Materials Testing / Q000379:methods; D014894:Weights and Measures