本特殊标准规定了婴儿运输孵化器的安全要求，但 如果制造商已在其风险管理文件中证明，当与设备治疗的益处进行权衡时，发现危险所带来的风险处于可接受水平，则通过证明等效安全性来遵守特定条款的替代方法将不会被判定为不符合。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This particular standard specifies safety requirements for INFANT TRANSPORT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.All current amendments available at time of purchase are included with the purchase of this document.