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内部资料
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本文档中包含的信息涉及深圳迈瑞生物医疗电子股份有限公司秘密,均为内部保密信息,未经许可,不得外发。
2.10 Additional testing, Part 15 Subpart B disclaimer
To ensure compliance with all non-transmitter functions the host manufacturer is responsible
for ensuring compliance with the module(s) installed and fully operational. For example, if a
host was previously authorized as an unintentional radiator under the Supplier’s Declaration of
Conformity procedure without a transmitter certified module and a module is added, the host
manufacturer is responsible for ensuring that the after the module is installed and operational
the host continues to be compliant with the Part 15B unintentional radiator requirements.
Since this may depend on the details of how the module is integrated with the host, SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. shall provide guidance to the host
manufacturer for compliance with the Part 15B requirements.