美国FDA 医疗器械体系法规QSR820中英文对照(三)

Sec. 820.3 Definitions. 定义(a) Act means the Federal Food, Drug, andCosmetic Act, as amended (secs. 201-903, 52 Stat. 1

Sec. 820.3 Definitions. 定义

(a) Act means the Federal Food, Drug, andCosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). All definitions insection 201 of the act shall apply to the regulations in this part.

a)法案:指美国联邦食品、药品和化妆品法案,例如已经修订的(secs. 201-903, 52 Stat. 1040 et seq.以及已经修订的(21 U.S.C. 321-394))。所有在法案201部分中的定义均适用于本文件。

(b)Complaint means any written, electronic, or oral communication that allegesdeficiencies related to the identity, quality, durability, reliability, safety,effectiveness, or performance of a device after it is released fordistribution.

b)抱怨:指产品放行销售后,任何与器械标识,质量,耐久性,可靠性,安全性,有效性,或性能有关的书面的、电子的,口头的不满。通常称其为顾客投诉或抱怨。

(c) Component means any raw material,substance, piece, part, software, firmware, labeling, or assembly which isintended to be included as part of the finished, packaged, and labeled device.

c)部件(组分):指任何意图作为终产品、包装产品、贴标产品一部分的原材料、物质、构件、零件、软件、固件、标签或其集合。

(d) Control number means any distinctivesymbols, such as a distinctive combination of letters or numbers, or both, fromwhich the history of the manufacturing, packaging, labeling, and distributionof a unit, lot, or batch of finished devices can be determined.

d)控制编码:指任何特定符号,例如字母或数字的特定组合,或字母与数字的特定组合,通过控制编码可以确定产品一个单元、批,或批产品的生产、包装、贴标以及销售历史。

(e) Design history file(DHF ) means a compilation of recordswhich describes the design history of a finished device.

e)设计历史文档:指描述终产品设计历史的汇编记录。

(f) Design input meansthe physical and performance requirements of a device that are used as a basisfor device design.

f)设计输入:指作为器械设计基础并被使用的器械物理能需求。

(g) Design outputmeans the results of a design effort at each design phase and at the end of thetotal design effort. The finished design output is the basis for the devicemaster record. The total finished design output consists of the device, itspackaging and labeling, and the device master record.

g)设计输出:指在每个设计阶段结果以及在最后总的设计成果的结果。已完成的设计输出是DMR的基础,部最终完成的设计输出由器械、他的包装、贴标和DMR组成。

(h) Design reviewmeans a documented, comprehensive, systematic examination of a design toevaluate the adequacy of the design requirements, to evaluate the capability ofthe design to meet these requirements, and to identify problems.

h)设计审核:指设计文件化的、综合性的、系统化的检查用以评估设计需求的充分性,评估符合这些需求的设计能力,并发现问题。

(i) Device history record (DHR) means a compilation of recordscontaining the production history of a finished device.

i)器械历史记录(DHR):指包含终产品历史的汇编记录。

(j) Device master record (DMR ) means a compilation of recordscontaining the procedures and specifications for a finished device.

j)器械主记录(DMR):指包含终产品规程和标准的汇编记录。

(k) Establish means define, document (inwriting or electronically), and implement.

k)建立:指定义、文件化(书面或电子形式)和实施。

(l) Finished devicemeans any device or accessory to any device that is suitable for use or capableof functioning, whether or not it is packaged, labeled, or sterilized.

l)终产品(成品器械):指无论产品是否包装、贴标或灭菌,都能满足使用或功能性要求的器械及器械附件。

(m) Lot or batch meansone or more components or finished devices that consist of a single type,model, class, size, composition, or software version that are manufacturedunder essentially the same conditions and that are intended to have uniformcharacteristics and quality within specified limits.

m)批号和批次:指由一个类型、型号、级别、尺寸、构图或软件版本在相同的条件下在一定的时间内生产出来的具有均一特性和质量的一个或多个组件或终产品。

(n) Management with executive responsibilitymeans those senior employees of a manufacturer who have the authority toestablish or make changes to the manufacturer's quality policy and qualitysystem.

n)具有最高管理职责的管理人员:指那些有权制定和改变制造商质量方针和质量体系的高级雇员。

(o) Manufacturer means any person whodesigns, manufactures, fabricates, assembles, or processes a finished device.Manufacturer includes but is not limited to those who perform the functions ofcontract sterilization, installation, relabeling, remanufacturing, repacking,or specification development, and initial distributors of foreign entitiesperforming these functions.

o)制造商:指任何设计、生产、组合、装配、加工终产品的人。制造商包括但不限于具有实施合同灭菌、安装、重贴签、再制造、重包装或标准开发的人,以及执行这些职能的国外组织的国内分销商。

(p) Manufacturingmaterial means any material or substance used in or used to facilitate themanufacturing process, a concomitant constituent, or a byproduct constituentproduced during the manufacturing process, which is present in or on thefinished device as a residue or impurity not by design or intent of themanufacturer.

p)生产物料:指在制造过程中,任何用于或用在生产工艺、中间产品、产成品生产的材料或物质,制造商的意图和设计是将这些物质放在在终产品中出现或在终产品上,而非杂质或残留。

(q) Nonconformity means the nonfulfillmentof a specified requirement.

q)不合格:指不能满足特定的要求。

(r) Product means components, manufacturingmaterials, in- process devices, finished devices, and returned devices.

r)产品:指部件,生产物料、中间产品(工艺器械)、成品器械和返厂器械。

(s) Quality means the totality of featuresand characteristics that bear on the ability of a device to satisfyfitness-for-use, including safety and performance.

s)质量:指赋予器械能力的特性和属性的总和,以满足包括安全性和性能的使用属性。

(t) Quality audit means a systematic,independent examination of a manufacturer's quality system that is performed atdefined intervals and at sufficient frequency to determine whether both qualitysystem activities and the results of such activities comply with quality systemprocedures, that these procedures are implemented effectively, and that theseprocedures are suitable to achieve quality system objectives.

t)质量审计(审核):指制造商质量体系系统化、独立性的检查。通常在固定的时间间隔和足够的频率下实施从而确定是否质量体系活动和这些活动的结果符合质量体系规程(程序),确定这些程序是否有效的得以实施,确定这些程序适用于完成质量体系目标。

(u) Quality policy means the overallintentions and direction of an organization with respect to quality, asestablished by management with executive responsibility.

u)质量方针:由一个具有最高管理职责的管理人员确定的一个与质量体系有关的全面的组织宗旨和方向。

(v) Quality system means the organizationalstructure, responsibilities, procedures, processes, and resources forimplementing quality management.

v)质量体系:指用于实施质量管理的组织构架、职责、规程(程序)、工艺(过程)和资源。

(w) Remanufacturer means any person whoprocesses, conditions, renovates, repackages, restores, or does any other actto a finished device that significantly changes the finished device'sperformance or safety specifications, or intended use.

w)再造商:对其完成的产品进行重新加工、翻新、重包装、修复或进行的别的其他活动的拥有工艺和条件的任何人。这些设备显然已经改变了制造完成后器械的性能或安全标准,或预期用途。

(x) Rework meansaction taken on a nonconforming product so that it will fulfill the specifiedDMR requirements before it is released for distribution.

x)返工:指对一个不合格品进行处理使其在放行用于销售前符合特定的DMR要求。

(y) Specificationmeans any requirement with which a product, process, service, or other activitymust conform.

y)标准(规范):指产品、工艺、服务或其他活动所必须符合的任何要求。

(z) Validation meansconfirmation by examination and provision of objective evidence that theparticular requirements for a specific intended use can be consistentlyfulfilled.

Z)验证:指通过检查或提供客观证据来证实器械预期用途的特定要求能够持续的得到满足。

(1) Processvalidation means establishing by objective evidence that a processconsistently produces a result or product meeting its predetermined specifications.

1)工艺验证(过程确认):指指通过客观的证据表明该工艺能够持续的生产出符合其事先确定的标准要求的产品或结果。

(2) Designvalidation means establishing by objective evidence that devicespecifications conform with user needs and intended use(s).

2)设计验证:指通过客观的证据表明设备标准符合用户需求和预期用途。

(aa) Verificationmeans confirmation by examination and provision of objective evidence thatspecified requirements have been fulfilled.

aa)确认:指通过检查和提供客观证据来证实已满足规定的要求。

(bb) Humancell, tissue, or cellular or tissue-based product (HCT/P) regulated as a devicemeans an HCT/P as defined in 1271.3(d) of this chapter that does not meet thecriteria in 1271.10(a) and that is also regulated as a device.

bbHCT/P:人细胞、组织或以细胞或组织为基础的产品按器械进行管理:指明确在本章中1271.3d)的HCT/P虽然不符合1271.10(a)的标准,但是仍然按照器械来监管。

(cc) Uniquedevice identifier (UDI) means an identifier that adequately identifies adevice through its distribution and use by meeting the requirements of 830.20of this chapter. A unique device identifier is composed of:

(1) A deviceidentifier --a mandatory, fixed portion of a UDI that identifies thespecific version or model of a device and the labeler of that device; and

(2) A productionidentifier --a conditional, variable portion of a UDI that identifies oneor more of the following when included on the label of the device:

(i) The lot or batch within which a device wasmanufactured;

(ii) The serial number of a specific device;

(iii) The expiration date of a specific device;

(iv) The date a specific device was manufactured.

(v) For an HCT/P regulated as a device, thedistinct identification code required by 1271.290(c) of this chapter.

器械唯一标识(UDI):是指在其销售和使用时用以充分标记器械的一种标识,从而满足本文83.20章节的要求。器械的唯一标识由以下内容构成:

1)一个器械标识:一个强制性的要求,作为UDI固定的一部分,显示器械以及该器械贴标机的特定版本或型号的标签。并且

2)一个产品标识:一个条件性的,作为UDI可以变化的一部分,显示在器械标签上的一个或多个下述内容的标签:

i)制造器械的批号批量

ii)特殊器械的序列批号;

iii)特殊器械有效期(货架寿命、过期日)

iv)特殊器械的生产日期。

v)对于按器械管理的HCT/P产品,本章中1271.290c)所要求的独特识别码。

Sec. 820.5 Quality system. 质量体系

Each manufacturer shall establish and maintain aquality system that is appropriate for the specific medical device(s) designedor manufactured, and that meets the requirements of this part.

每个制造商应当建立和维护一个质量体系,适用于特定器械设计或制造,并且符合本部分的要求。

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