交易与确认方式。
设计输出应予文件化，并以对设计输入要求能被查证及作有效性确认方式予以表达。
Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.
明示性同意，顾名思义，需要收件人实际确认，确认方式可以是书面，也可以电子或口头方式。
Express consent requires an actual communication by the recipient by written, electronic or verbal means to positively indicate that the recipient wishes to receive the messages.
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