通用安全和性能要求检查表GSPR Check List.pdf

MDR Annex Ⅰ附录一 General safety and performance requirements Checklist 通用安全和性能要求检查表 Applica Evidence compliance or reason Location General safety and performance requirements Standards Used 通用安全和性能要求 blity 应用标准 for no applicability -section 符合性证据或不适用理由 适用性 位置-章节 CHAPTER I GENERAL REQUIREMENTS 第1章 一般要求 1.Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high. 1.器械应具备制造商预期的性能，并确保其设计和结构在正常使用条件下适用于 其预期用途。器械应安全有效，且不得对患者的临床症状或安全或者使用者或其 他人员（如适用）的安全和健康造成损害，在最大限度保护健康和安全的同时， 器械使用的可接受风险与其对患者的受益相比，应在可接受范围内，并应考虑到 符合现有认知水平。 2.The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio. 2.本附录中尽可能降低风险的要求，指尽可能降低风险的同时不会对受益-风险 比产生不利影响。 3.Manufacturers shall establish, implement, document and maintain a risk management system.