CE技术文件检查表.pdfVIP

Requirement / Reference Document (VO 2017/745) Content / Guide Applicability / Compliance shown in evidence Remark / Comment Annex II, Section 1.1 Please provide a detailed overview about the device including Device Description and any combination(s) with other equipment(s). This enclose: Specification - A description of the device, which should enable understanding of the design, packaging, sterilization, or other characteristics of the device. - Sufficient information to distinguish different variants of the device, and the intended purpose of different design features. (For example, if one variant of a device has a coating and another does not, what is the intended purpose of that coating, and why are both variants considered to meet the requirements for safety and performance?) Annex II, Section 1.1 a) Product or trade name and a general description of the device including pictures and schematics, which should be provided wherever possible to enable an understanding of the device design features and intended purpose. The enclose also a reference list between the tradename of the equipment and