Basic Requirements Checklist for Safety and Effectiveness of In Vitro Diagnostic (IVD) Medical Devices In vitro diagnostic (IVD) medical devices play a crucial role in healthcare by providing important information for the diagnosis, treatment, and monitoring of diseases. To ensure the safety and ...
requirements on microbiology. Sterile medical devices shall be N produced in the corresponding control state such as the This product is corresponding level of not sterile purifying the environment. medical device. B2.6 B2.7 B3 B3.1 B4 B4.1 B4.2 Non sterile medical devices’ packaging should maint...
医疗器械安全有效的基本要求清单英文版3. Safe and effective basic requirements list of medical devices Item number Requirement Applicable methods to prove compliance A General principle Medical devices should be designed and manufactured in the expected conditions and purposes, used according to the ...
医疗器械安全有效基本要求清单英文版 Safe and effective essential requirements list of medical devices Article No. Requirement Applicable (Y/NA)The adoption ways of verification compliance Documentation A General Requirements A1 The medical devices must be designed and manufactured in such a way that, ...
3. Safe and effective basic requirementslistof medical devices Item number Requirement Applicable methods to prove compliance Documents that provide objective evidence for compliance A General principle A1 Medical devices should be designed and manufactured in the expected conditions and purposes, used ...
医疗器械安全有效的基本要求清单英文版.doc,—— PAGE 28 — PAGE 11 3. Safe and effective basic requirements list of medical devices Item number Requirement Applicable methods to prove compliance Documents that provide objective evidence?for compliance A Ge
1、3. safe and effective basic requirements list of medical devicesitem numberrequirementapplicablemethods to prove compliancedocuments that provide objective evidencefor complianceageneral principlea1medical devices should be designed and manufactured in the expected conditions and purposes, used acco 2、...
3. Safe and effective basic requirements list of medical devices Item number Requirement Applicable methods to prove compliance Documents that provide objective evidence for compliance A General principle A1 Medical devices should be designed and manufactured in the expected conditions and purposes, used ...
1、3. Safe and effective basic requirements list of medical devicesItem numberRequirementApplicablemethods to prove complianceDocuments that provide objective evidence for complianceAGeneral principleA1Medical devices should be designed and manufactured in the expected conditions and purposes, use 2、d ...