设计验证通常的方法是将输入要求与过程的输出进行比较，如各级复审。 此外

设计验证通常的方法是将输入要求与过程的输出进行比较，如各级复审。
此外，设计验证方法还可包括：比较法（如变换计算方法比较结果或与证实的类似设计和开发项目比较结果）、试验、模拟法等。
适用的验证方法通常由验证人员确定并应符合法规或规范要求。
4.6 设计确认
为确保产品能够满足规定的或已知预期使用或应用的要求，应按所策划的安排（见7.3.1）对设计进行确认。工程设计和咨询的确认由业主、权力机关分阶段实施，通常包括：
a) 可行性研究报告的评估；
b) 方案设计审查；
c) 初步设计审批；
d) 权力机关的施工图审查。
只要可行，确认应分阶段在产品交付或实施之前完成，确认结果及任何必要措施的记录应予保存。需要时，院或所应委派能胜任的人员参加业主和权力机关的设计确认活动，并记录设计确认的结果。在确认的后续阶段应对确认提出的问题采取必要的措施。如正式的审批意见与记录有不一致之处，应予解决。
设计确认的记录由工程负责人负责保存，随其它技术文件一并归档。
4.7 设计更改的控制
设计和开发输出文件批准发布后，所有的更改应按要求实施控制。
设计更改的控制应包括：

















ผลลัพธ์ (อังกฤษ) 1:

Design verification method is usually input requirements and compare the output of the process, such as levels of review. In addition, the verification methods may include: comparative law (such as calculation methods comparison results or results confirmed similar design and development projects), testing, simulation, and so on. Applicable authentication method is usually determined by the Inspector and shall be consistent with regulations or specifications.4.6 design validationTo ensure that products meet the requirements of or given an expected use or application requirements, according to the planned arrangements (see 7.3.1) to confirm the design. Confirmed by the owner of the engineering design and consultation, the authorities phased implementation, usually includes:A) assessment of the feasibility study report;B) design review; C) preliminary design approval; D) Authority review of construction drawings. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product in stages, records of the results of validation and any necessary actions shall be maintained. When needed, or should engage qualified persons to participate in owners and design validation activities of the authority, and record the results of design validation. Recognizes the issues raised should confirm the subsequent phases to take necessary measures. Formal examination opinions and records an inconsistency should be resolved. Design verification of records kept by the project manager is responsible for, together with all the other technical documents archive.4.7 control of design changes After approval of the design and development outputs the file was released, all changes should be required to exercise control. Control of design changes should include:

ผลลัพธ์ (อังกฤษ) 2:

Design verification usual method is to input and output requirements and processes are compared, as all levels of review.
In addition, the design verification method may further include: comparative law (such as transform calculation method or comparison results are compared to similar design and development projects confirmed), testing, simulation method.
Verification method applies generally determined by the verifier and shall comply with the regulations or regulatory requirements.
4.6 Design Verification
to ensure that products meet the requirements specified or known intended use or application, shall be planned arrangements (see 7.3.1 ) to confirm the design. Confirm engineering design and consulting phased implementation by the owners, authorities typically include:
A) the assessment of the feasibility study;
B) design review;
C) the preliminary design approval;
D) construction drawing review the authority.
Wherever practicable, validation shall be staged prior to the delivery or implementation is completed, the results confirm the record and any necessary actions shall be saved. When needed, the hospital or the delegated competent authority attended owners and design verification activities, and record the results of design validation. Confirmed at a later stage to deal with the issues raised confirmation to take the necessary measures. If the formal approval of the views of the recording inconsistencies and should be resolved.
Recording engineering design validation by the person in charge responsible for the preservation, archiving together with other technical documents.
4.7 control design changes
after the approval of the design and development output files released, all changes should be required to exercise control.
Control design changes should include: z

ผลลัพธ์ (อังกฤษ) 3:

The usual method of design verification is to compare the input requirements with the output of the process, such as the level of review.In addition, the design verification method can also include: comparison method (such as transformation calculation method comparison results or similar design and development project comparison results), test, simulation, etc..The applicable verification methods are usually determined by the verification personnel and shall be in compliance with the requirements of the regulations or specifications.4.6 design validationIn order to ensure that the product can meet the specified or known intended use or application requirements, it shall be confirmed in accordance with the planned arrangements (see 7.3.1). The construction design and consultation of the confirmation by the owners, the power of the phased implementation, usually including:Evaluation of the feasibility study report of a;B) programme design review;C) preliminary design approval;D) construction drawing review of the authority.As long as it is feasible, the confirmation shall be completed before the delivery or implementation of the product, the records of the results and any necessary measures shall be kept. When required, the hospital or the person shall be appointed to participate in the activities of the owners and the authority of the design confirmation activities, and record the results of the design confirmation. Take the necessary steps to deal with the problems identified in the follow-up period. If the formal approval of the views and records are inconsistent, should be resolved.The records of the design confirmation shall be kept by the responsible person of the project and shall be filed with other technical documents.4.7 design change controlAfter the design and development of the output document is approved, all changes shall be implemented as required.Control of design changes shall include:L