英语翻译4.0 Environmental4.1 Anticipated conditions in manufactu

英语翻译
4.0 Environmental
4.1 Anticipated conditions in manufacturing
4.1.1 Temperature of 50° to 100° F
4.1.2 Relative humidity of 10 to 95%.
4.2 Anticipated conditions in sterilization
4.2.1 Temperature of 50° to 100° F
4.2.2 Relative humidity of 10 to 95%.
4.3 Anticipated conditions in Distribution
4.3.1 Temperature of -10° to 135° F
4.3.2 Relative humidity of 10 to 95%.
4.4 Anticipated conditions in Storage
4.4.1 Temperature of 60° to 100° F
4.4.2 Relative humidity of 20 to 80%.
4.5 Anticipated conditions in Use
4.5.1 Temperature of 60° to 100° F
4.5.2 Relative humidity of 20 to 80%.
5.0 Packaging- needs update- AML
5.1 Packaging requirements
5.1.1 Package consists of a tray with snap-on lid which covers the handle.Both are made of HIPS (High Impact Polystyrene)
5.1.2 Devices are inserted into a Tyvek/Nylon pouch,then sealed.
5.1.3 Sealed pouches are packaged singly in a labeled clay-coated newsback display box.
5.2 Label requirements
5.2.1 Product labels will be included on the pouch and the display box.
5.2.2 Product labeling shall include but is not limited to the following:
5.2.2.1 Product (brand) name
5.2.2.2 Package contents
5.2.2.3 Catalog number
5.2.2.4 Lot number & expiration date
5.2.2.5 Indication of sterility
5.2.2.6 Single Use indication
5.2.2.7 Latex Free symbol
5.2.2.8 Storage Temperature indications
5.2.2.9 Physician sale limitation
5.2.2.10 Instruction for use booklet
5.2.2.11 Registered agent name and address
5.3 Transit test requirements
5.3.1 Packaging shall pass ship tests for drop and for vibration as outlined in ISTA-2A.ISTA-2A covers testing of individual packaged products weighing 150 lbs or less when prepared for shipment.Includes drop testing,vibration testing,and conditioning the sample to simulate environmental conditions.

4.0环境
4.1生产预期的条件
4.1.1温度50 °到100℉
4.1.2相对湿度10至95％.
4.2杀菌预期的条件
4.2.1温度50 °到100℉
4.2.2相对湿度10至95％.
4.3预期的条件分布
4.3.1温度为-10 °到135 ° F
4.3.2相对湿度10至95％.
4.4存储预期的条件
4.4.1温度60 °到100℉
4.4.2相对湿度在20至80％.
4.5在使用预期的条件
4.5.1温度60 °到100℉
4.5.2相对湿度在20至80％.
5.0包装,需要更新白血病
5.1包装要求
5.1.1软件包包括一个单元托盘上盖子,其中包括处理.两者都是由高抗冲聚苯乙烯（高抗冲聚苯乙烯）
5.1.2设备插入到一卫强/尼龙邮袋,然后密封.
5.1.3密封袋单独封装在一个标有粘土涂层newsback显示框.
5.2标签要求
5.2.1产品标签将包含在邮袋和