美国FDA 医疗器械体系法规QSR820中英文对照(八)

Subpart K--Labeling andPackaging Control标签和包装控制Sec. 820.120 Device labeling.器械标签Each manufacturer shall estab

Subpart K--Labeling andPackaging Control 标签和包装控制

Sec. 820.120 Device labeling.器械标签

Each manufacturer shall establish and maintainprocedures to control labeling activities.

制造商应当建立和维护用于控制标签活动的规程。

(a) Labelintegrity. Labels shall be printed and applied so as to remain legible andaffixed during the customary conditions of processing, storage, handling,distribution, and where appropriate use.

a)标签的完整性。标签应是打印和印刷的。在其加工、存储、搬运、交付使用的常规条件下应当清晰可辨,粘贴牢固。

(b) Labelinginspection. Labeling shall not be released for storage or use until adesignated individual(s) has examined the labeling for accuracy including,where applicable, the correct unique device identifier (UDI) or universalproduct code (UPC), expiration date, control number, storage instructions,handling instructions, and any additional processing instructions. The release,including the date and signature of the individual(s) performing theexamination, shall be documented in the DHR.

    b)标签的检验。在标签放行存储或使用前,相应的授权人应对标签进行正确性的检查。包括,适用时,正确的唯一器械标识(UDI)或内部产品代码(UPC)、有效期、控制码、存储条件、运输说明、以及其他的处置要求。包括实施检查人员签字和签署日期的放行措施赢的那个记录在DHR中。

(c) Labelingstorage. Each manufacturer shall store labeling in a manner that providesproper identification and is designed to prevent mixups.

    c)标签存储。制造商应当以一种提供适当标识的方式来存储标签,其目的是防止混淆。

(d) Labelingoperations. Each manufacturer shall control labeling and packagingoperations to prevent labeling mixups. The label and labeling used for eachproduction unit, lot, or batch shall be documented in the DHR.

    (d)标签的操作。制造商应当控制标签和包装操作来预防标签混淆。用于每个产品单元、批次的标签和标识都应当在DHR中予以记录。

(e) Controlnumber. Where a control number is required by 820.65, that control numbershall be on or shall accompany the device through distribution.

e)控制码。Sec.820.65要求下控制码,在整个销售过程中应始终附着在或伴随着产品。

修订历史:[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 55822, Sept. 24,2013]

Sec. 820.130 Device packaging.器械包装

Each manufacturer shall ensure that devicepackaging and shipping containers are designed and constructed to protect thedevice from alteration or damage during the customary conditions of processing,storage, handling, and distribution.

    制造商应保证设计和构造的器械包装和货运箱能够保护器械在运输加工、存储、搬运、交付使用的常规条件下不发生改变或损坏。

Subpart L--Handling,Storage, Distribution, and Installation 搬运、贮存、交付和安装

Sec. 820.140 Handling.搬运

Each manufacturer shall establish and maintainprocedures to ensure that mixups, damage, deterioration, contamination, orother adverse effects to product do not occur during handling.

    制造商应当建立和维护相应的规程来保证在搬运期间不会发生混淆、损坏、质量下降、污染或其他对产品质量产生的不利影响。

Sec. 820.150 Storage.存储

(a) Each manufacturer shall establish and maintainprocedures for the control of storage areas and stock rooms for product toprevent mixups, damage, deterioration, contamination, or other adverse effectspending use or distribution and to ensure that no obsolete, rejected, ordeteriorated product is used or distributed. When the quality of productdeteriorates over time, it shall be stored in a manner to facilitate properstock rotation, and its condition shall be assessed as appropriate.

    a)制造商应当建立和维护相应的程序,用于控制产品存储区域和库房,从而预防混淆、损害、质量下降、污染或其他不利影响,保证废品、拒收品、质量下降的产品不被使用和销售。

(b) Each manufacturer shall establish and maintainprocedures that describe the methods for authorizing receipt from and dispatchto storage areas and stock rooms.

b)制造商应当建立和维护相应的程序,用以描述出入库权限的方法。

Sec. 820.160 Distribution.交付

(a) Each manufacturer shallestablish and maintain procedures for control and distribution of finisheddevices to ensure that only those devices approved for release are distributedand that purchase orders are reviewed to ensure that ambiguities and errors areresolved before devices are released for distribution. Where a device's fitnessfor use or quality deteriorates over time, the procedures shall ensure thatexpired devices or devices deteriorated beyond acceptable fitness for use arenot distributed.

    a)制造商应当建立和维护相应的程序用于成品器械的控制和交付来保证只有那些经过批准放行的器械才能被交付,并且采购指令应当经过审核来保证在器械放行销售之前有偏差(不清楚和错误)得以解决。当器械适用和质量跌幅超过期限时,该程序应当保证超期的器械或器械质量下降超过了可接受的适用期时,都不得进行销售。

(b) Each manufacturer shall maintain distributionrecords which include or refer to the location of:

b)制造商应当保留销售记录,记录应当涵盖以下内容:

(1) The name and address of the initial consignee;最初销售者的名称和地址

(2) The identification and quantity of devicesshipped; 发运设备的标识和数量

(3) The date shipped; and 发运日期;并且

(4) Any control number(s) used.任何使用的控制码。

 

Sec. 820.170 Installation.安装

(a) Each manufacturer of a device requiringinstallation shall establish and maintain adequate installation and inspectioninstructions, and where appropriate test procedures. Instructions and proceduresshall include directions for ensuring proper installation so that the devicewill perform as intended after installation. The manufacturer shall distributethe instructions and procedures with the device or otherwise make themavailable to the person(s) installing the device.

    a)对有安要求的器械,制造商应当建立和维护适当的安装和检测说明书,以及适当的测试规程。安装和规程应包括能够确保设备正确安装的指导,使设备在安装后能够按照预期的要求工作。制造商应当连同器械一起交付说明书和规程或者使安装的器械人员掌握这些规程和说明。

(b) The person installing the device shall ensurethat the installation, inspection, and any required testing are performed inaccordance with the manufacturer's instructions and procedures and shalldocument the inspection and any test results to demonstrate properinstallation.

    (b)安装器械的人员应当保证依据制造商说明书和规程实施相应的安装、检测以及任何所需的测试。并记录检测、和任何测试的结果来证明器械得以正确安装。

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