INTERNATIONA
STANDARD L国际标准ISO22716
First edition
2007-11-15
第一版本发行于
2007年11月15日
Cosmetics — Good Manufacturing
Practices (GMP) — Guidelines on Good
Manufacturing Practices
化妆品—良好生产规范（GMP）准则
ISO 22716:2007(E)
标准号
ISO22716:2007(E)
Contents Page Introduction (1)
1 Scope (1)
2 Terms and definitions (1)
3 Personnel (4)
4 Premises (6)
5 Equipment (8)
6 Raw materials and packaging materials (10)
7 Production (11)
8 Finished products (14)
9 Quality control laboratory (15)
10 Treatment of product that is out of specification (17)
11 Wastes (17)
12 Subcontracting (18)
13 Deviations (19)
14 Complaints and recalls (19)
15 Change control (19)
16 Internal audit (20)
17 Documentation (20)
目录
介绍 (1)
1 范围 (1)
2 术语和定义 (1)
3 员工 (4)
4 厂房 (6)
5 设备 (8)
6 原料和包材 (10)
7 生产 (11)
8 成品 (14)
9 实验室质量控制制 (15)
10 不合格品的处理.......................................................... .17
11 废弃物 (17)
12 外包 (18)
13 偏差 (19)
14 投诉和召回 (19)
15 变更控制 (19)
16 内审 (20)
17 文档 (20)
Introduction
These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.
These guidelines have been written to allow them to be used following the flow of products from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a each major section.
‘principle’ is added to
Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgement and risk assessments. The objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets defined characteristics.
Documentation is an integral part of Good Manufacturing Practices.
介绍
这份准则为化妆品良好生产规范做出指导，是适合化妆品行业并考虑了行业的具体要求，在人员，技术和影响产品质量的综合因素方面提供了系统性的和实际性的建议。
这个指导是为了让员工遵守产品接收到装运的流程下如何去利用资源。为了达到此目的，在每一个章节里都添加了“原则”这一栏。
良好生产规范中的质量保证发展观念是通过描述建立在科学有效的判定和风险评估上的工厂活动来完成的，这份准则的目的是为了界定能让你获得达标产品的活动。
文件是GMP不可或缺的一部分。
ISO22716:2007(E)
化妆品良好生产规范准则
1 Scope范围
This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products
此国际标准为化妆品生产，控制，储存和装运提供指南
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. Safety and environmental aspects are inherent responsibilities of the company and could be governed by local legislation and regulation.
这个标准包含产品质量的各个方面但不包括员工安全和对环境的保护方面，安全和环境保护是公司的应的责任，可以通过当地的法律和法规加以管制
These guidelines are not applicable to research and development activities and distribution of finished products.
这些准则并不适用于设计和开发和产品营销活动。
2 Terms and definitions术语和定义
For the purposes of this document, the following terms and definitions apply.
以下术语和定义对于本文件是适用的
2.1 acceptance criteria接收标准
numerical limits, ranges, or other suitable measures for acceptance of test results
数值限度，范围或者其他可作为接受测试结果的方法
2.2 audit审核
systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives
为获得审核证据并对其进行客观评价，以确定满足审核准则的程度而进行的系统的、独立的、形成文件的过程。
2.3 Batch批
defined quantity of raw material, packaging material or product issued from one process or series of processes so that it
could be expected to be homogeneous
从某个或多个操作获得的、认为是一致的特定数量的原料，包材或产品。
2.4 batch number批号
distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch
单个数字，字母，或字母和数字结合的，用来指定识别一批产品的代码.
2.5bulk produc散装产品
any product which has completed manufacturing stages up to, but not including, final packaging
经过所有制造工艺过程的产品，除了没有填充到独立包装的产品。
2.6Calibration校准
set of operations that establish, under specified conditions, the relationship between values indicated by a measuring
instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard
在特定条件下，通过一系列操作在测量仪器或测量系统所指示的量值，或事物量具或参考事物表示的值，和按标准
实现的相应值间建立起一种关系。
2.7 change control变更控制
internal organization and responsibilities relative to any planned change of one or several activities covered by the Good Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond
to the defined acceptance criteria
为确保生产，包装，控制，储存符合接收标准，组织所作的内部机构、职责与GMP内容有关的任何计划的变动。
2.8Cleaning 清洗
all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible
dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action, mechanical action, temperature, duration of application
为确保达到洁净水平，隔离或消除表面赃物的所有操作。例如用化学作用，机械作用，温度，时间等方法。
2.9Complaint投诉
external information claiming a product does not meet defined acceptance criteria
外部信息断言成品有质量缺陷。
2.10Contamination接触污染
occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product
指在产品中发现任何不应出现化学的，物理的，生物的物质的事件。
2.11Consumables耗材
materials such as cleaning agents and lubricants that are used up during cleaning, sanitization ormaintenance operations
指某些在清洁、消毒或维护中消耗的材料诸如清洁剂、润滑油等。
2.12contract acceptor受托方
person, company or external organization carrying out an operation on behalf of another person, company or organization
代表某人、公司、组织实施操作的个人、公司或外部的组织。
2.13
Control控制
verification that acceptance criteria are met 确认可接受准则得到满足
2.14
Deviation偏差
internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices
由于计划的或非计划的临时情况，组织和职责偏离了GMP所覆盖的一个或多个活动的特定要求。
2.15finished product成品
cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment
化妆品产品经历了所有的生产阶段，包括在其最后的容器包装，出货。
2.16in-process control过程控制
controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria
对生产过程进行监控，如果需要可对过程进行调整以确保产品达到可接受准则。
2.17internal audit内审
systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives
由内部有能力的人员实施的系统和独立的检查，目的是为了确定活动是否覆盖了与指南和策划的相关结果，以及这些安排是否得到有效实施并适用于实现目标。
2.18major equipment主要设备
equipment specified in production and laboratory documents which is considered essential to the process
在生产和实验室文件中详细说明的，被认为是对加工必不可少的设备
2.19Maintenance维护
any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition为了保持房屋和设备处于适宜的工作状态所实施的定期或非计划的维护和验证检查。
2.20manufacturing operation制造过程
set of operations from the weighing of raw materials to the making of the bulk product
从原料的称量到散装产品的制造必走的过程
2.21out-of-specification超出规格
examination, measurement or test result that does not comply with defined acceptance criteria
检查，测量或测试的结果不符合规定的可接收标准
2.22packaging operation包装过程
all packaging steps including filling and labelling, which a bulk product has to undergo in order to become a finished product所有包装步骤包括填充，就是散装产品到成品必走的过程
2.23packaging material包材
any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation任何用于包装产品的包装材料，除了用于运输的外包装
NOTE Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.注意：包材可分为第一和第二材料根据它们是否与产品直接接触
2.24Plant工厂
location for production of cosmetic products化妆品厂的位置。
2.25Premises厂房
physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging, control
and shipment of product, raw materials and packaging materials
物理位置，建筑物和支撑结构，用于实施接收，储存，制造，包装，控制和产品，原料，包材运输等活动
2.26production生产
manufacturing and packaging operations制造和包装过程
2.27
quality assurance质量保证
all those planned and systematic activities necessary to provide confidence that a product satisfies given acceptance criteria
为了确保产品符合标准所进行的计划和系统的活动。
2.28raw material原料
any substance going into or involved in the manufacturing of a bulk product
制造一个散装产品所引入的或有关的物质
2.29Recall召回
decision made by a company to call back a product batch that has been put on the market
决定从市场上回收某个批次的产品。
2.30Reprocessing返工
re-treatment of all or part of a batch of finished product or bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations
对确定生产阶段的所有或部分不合格成品或散装产品重新加工以让其允收。
2.31Return返回
sending finished cosmetic products which may or may not present a quality defect back to the plant
将可能有或没有质量缺陷的成品退回工厂。
2.32Sample样品
one or more representative elements selected from a set to obtain information about that set
从一批里选择出的一个或多个具有典型要素的，可以获得那批信息的产品
2.33Sampling抽样
set of operations relating to the taking and preparation of samples操作中涉及选择和准备样品的活动。
2.34Sanitization消毒
operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set NOTE It is the action of reducing generally invisible contaminants from a surface
在钝化的被污染的表面实施的操作，目的是减少不良微生物。
注：它是一个减少通常不可见的污染的操作。
2.35Shipment装运
set of operations relative to the preparation of an order and its putting in a transport vehicle
有关订单的准备和装入运输工具的一系列行为。
2.36Waste废弃物
any residue of a production operation, transformation or use, any substance, material, product that its holder intends for
disposal
生产过程产生的或转化而成的，或者使用后的原料，产品等需要废弃的任何物质。
3 Personnel员工
3.1 Principle原则
Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality.
任何规范中提到的参与活动的人员应具备生产，控制，储存合格品的训练技能
3.2 Organization组织
3.2.1 Organization chart组织结构
3.2.1.1 The organizational structure should be defined in order that the organization and functioning of the staff of the company be understandable. It should be appropriate for the size of the company and the diversity of its products.
应制定组织结构，以确保公司组织和员工职能能被理解，组织机构应适合公司的规模和产品的多样性
3.2.1.2 Each company should ensure that there are adequate staffing levels in the different scope of activity, according to
the diversity of its production.根据产品多样性，每个公司应确保在活动的不同范围都有充足的员工
3.2.1.3 The organization chart should show the independence, from the other units of the plant, of each quality unit, such as quality assurance unit and quality control unit. The quality assurance and quality control responsibilities can be undertaken
by a separate quality assurance unit and a quality control unit, or they can be undertaken by a single unit.组织机构应表明质量保证和质量控制的部门独立于工厂的其它部门，质量保证和质量控制的职责可以分成两个也可以合并成一个。
3.2.2 Number of people员工数量
The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines.
公司应该有一定数量的经过适当有关这个规范培训的员工
3.3 Key responsibilities主要职责
3.3.1 Management responsibilities管理职责
3.3.1.1 The organization should be supported by the top management of the company
.组织应当得到这个公司最高管理的支持
3.3.1.2 The implementation of Good Manufacturing Practices should be the responsibility of top
management and should require the participation and commitment of personnel in all departments and at all levels within
the company
.GMP的实施是最高管理阶层的职责并且需要所有部门和每个员工的支持和参与
3.3.1.3 Management should define and communicate the areas in which authorized personnel are
allowed to access.
管理职责需要确定相关人员的授权并与之沟通
3.3.2 Responsibilities of personnel个人职责
All personnel should:每个人都应;
a) know their position in the organizational structure知道自己在组织结构中的位置
b) know their defined responsibilities and activities;知道被规定的责任和行为
c) have access to and comply with documents relevant to their particular responsibility scope;有机会获得并符合其特殊的
职责范围的文件
d) comply with personal hygiene requirements; 遵守个人卫生要求
e) be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities;被鼓励报告非法或不符规定的可能发生在他们职责范围的行为
f) have adequate education training and skills to perform the assigned responsibilities and activities.有足够的教育背景和
技能从而胜任规定的职责和活动
3.4 Training培训
3.4.1 Training and skills培训和技能
Personnel involved in production, control, storage and shipment should have skills based on relevant training and experience acquired, or any combination thereof, that are appropriate to their responsibilities and activities.
涉及生产，控制，储存和装运的员工要有相关的培训和经验，或者其他任何适合其工作的等等
3.4.2 Training and Good Manufacturing Practices培训和良好生产规范
3.4.2.1 Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be provided for all personnel.良好生产规范培训都要提供给每个人
3.4.2.2 The training needs of all personnel, regardless of level or seniority in the company, should be identified and a corresponding training programme should be developed and implemented.这个每个人需要培训，不管什么水平和位置，
所相应的培训项目要产生并且实施
3.4.2.3 Considering the expertise and experience of the respective personnel, training courses should be tailored to be appropriate to the jobs and responsibilities of individuals.
考虑到每个员工的特长和经验不同，培训可以根据每个人的工作和职责来设定
3.4.2.4 According to the needs and in-house resources available, training courses may be designed and executed by the company itself or with the help of expert external organizations, if necessary.根据需要和现有的可利用资源，培训课程可
由公司自己编制或由外部专业人士编写
3.4.2.5 Training should be regarded as a constant and on-going process that is subject to regular
updates.
培训应该是持续的并能及时更新
3.4.3 Newly recruited personnel新员工招聘
Besides basic training on the theory and practice of Good Manufacturing Practices, newly recruited personnel should receive training appropriate to the duties assigned to them.
除了基本的理论和GMP培训，新员工还要他们岗位的培训
3.4.4 Personnel training evaluations个人培训评估
Knowledge accumulated by personnel should be evaluated during and/or after training
.在培训过程中或者过后，个人知识的积累需进行评估
3.5 Personnel hygiene and health个人卫生和健康
3.5.1 Personnel hygiene个人卫生
3.5.1.1 Hygiene programmes should be established and adapted to the needs of the plant. These
requirements should be understood and followed by every person whose activities take them into production, control and storage areas.
就建立卫生程序并满足工厂的需要，在生产，控制，储存区域工作的人员要理解这些要求并且遵守
3.5.1.2 Personnel should be instructed to use hand washing facilities
.每个人要被指导如何使用洗手设备
3.5.1.3 Every person entering production, control and storage areas should wear appropriate clothing and protective garments to avoid contamination of cosmetic products.
进入生产，控制，储存区域人员要穿好防护衣从而避免污染产品
3.5.1.4 Eating, drinking, chewing, smoking or the storage of food, drink or smoking materials or personal medication in the production, control and storage areas should be avoided.
应避免在生产，控制，储存区域吃东西、喝水、吃口香糖、抽烟、储存食物，个人药品。
3.5.1.5 Any unhygienic practice within the production, control and storage areas or in any other area where the product
might be adversely affected should be forbidden
.任何不卫生的行为都不能出现在生产，控制，储存区域或者对产品造成影响的区域
3.5.2 Personnel health个人健康
Steps should be taken to ensure, as far as is practicable, that any person affected by an apparent illness or having open lesions on the exposed body surface should be excluded from direct contact with product until the condition is corrected or determined by medical personnel that the quality of cosmetic products will not be compromised
.任何适用的措施应该采取以确保病人和在皮肤暴露部位有开放性伤口的人员不得直接接触产品，直到情况改善或
者医疗人员确认后，这样才能确保产品不受影响
3.6 Visitors and untrained personnel来访者和未被培训的人员
Visitors or untrained personnel should preferably not be taken into production, control and storage areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.这些人不能进入生产，控制，储存区域，如果不得不进入，他们需要被提
前告知一些信息，特别是个人卫生和防护服规定。他们应被密切的指导。
4 Premises厂房
4.1 Principle原则
4.1.1 Premises should be located, designed, constructed and utilized so as:要定位，设计，建设和利用以：
a) to ensure protection of the product;确保产品防护
b) to permit efficient cleaning, if necessary, sanitizing and maintenance;必要时，允许有效清洗，消毒和维修
c) to minimize the risk of mix-up of products, raw materials and packaging materials.最大程度降低产品原料和包材交叉
污染的风险
4.1.2 Premises design recommendations are described in these guidelines. Design decisions should be based on the type of cosmetic product produced, existing conditions, cleaning and, if necessary, sanitizing measures used.
厂房设计的一些建议已经在规范里描述了。设计时应考虑化妆品的类型，工厂现状、清洁设施（必要时考虑消毒设
施）
4.2 Types of area区域类型
Separate or defined areas should be provided for storage, production, quality control, ancillary, washing and toilets.
储存，生产，质量控制，辅助性设施，洗手区域和厕所等区域应有隔离的或者指定区域
4.3 Space空间
Sufficient space should be provided to facilitate operations such as receipt, storage and production.应提供足够的空间，以便于实施操作，如收货，储存和生产
4.4 Flow流动性
Flow of materials, products and personnel through the building or buildings should be defined in order to prevent mix-ups.
原料，产品，人员在建筑之间的流动应被确定以避免交叉污染
4.5 Floors, walls, ceilings, windows地面，墙壁，天花板，窗户
4.5.1 Floors, walls, ceilings and windows in production areas should be designed or constructed for ease of cleaning and, if necessary, sanitization and be kept clean and in good repair.
生产区域的地面，墙壁，天花板，窗户应设计为易清洗的，必要时可以消毒的，以保持清洁和良好状态
4.5.2 Windows should be of non-opening design where ventilation is adequate. If windows are opened to the outside environment, they should be properly screened.
当其中空气流通充分时，窗应该设计为不开启的。如果窗是直接开向室外的，应有纱窗。
4.5.3 New construction of production areas should incorporate considerations for proper cleaning and maintenance. Design
of new construction should include smooth surfaces if appropriate and these surfaces should allow for resistance to corrosive cleaning and sanitizing agents.
新的生产区域的设计应考虑清洗和维修两点，包括光滑的表面并能抵抗腐蚀性清洗和消毒剂的作用
4.6 Washing and toilet facilities盥洗设施
Adequate, clean, washing and toilet facilities should be provided for personnel. The washing and toilet facilities should be differentiated from, but accessible to, production areas. Adequate facilities for showering and changing clothes should be provided when appropriate.
盥洗设施要提供给员工，应与生产区域分开，但应直接通向生产区。适当时要提供淋浴和更衣设施。
4.7 Lighting灯光
4.7.1 Adequate lighting, that is sufficient for operations, should be installed in all areas.
所有区域都应安装充足的光线适合作业，
4.7.2 Lighting should be installed in a manner to ensure containment of any debris from potential breakage.Alternatively, measures should be taken to protect the product.
灯的安装方式应采用万一发生破损时不会对产品污染的方式。否则，要采取措施保护产品。
4.8 Ventilation通风设备
Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should be taken to protect the product.
在作业时通风要充足，如果不能，要采取措施保护产品。
4.9 Pipework, drains and ducts管道，排水沟，排泄管
4.9.1 Pipework, drains and ducts should be installed in such a manner so that drip or condensation does not contaminate materials, products, surfaces and equipment.
安装时要考虑到水滴或冷凝水不能污染原料，产品，容器、设备表面。
4.9.2 Drains should be kept clean and should not allow back flow.
排水沟应保持清洁而且不能回流
4.9.3 Design considerations should be given to the following:设计所要考虑的
a) exposed overhead roof beams, pipes and ducts should be avoided; 当屋顶横梁外露时，管道和排泄管应避免
b) exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently separated to allow thorough cleaning;外露的管道不能接触墙，但可以由托架拖着或者吊着，要充分隔离以便彻底清洗
c) alternatively, specific measures should be taken to protect the product.否则，要采取措施保护产品。
4.10 Cleaning and sanitization清洗消毒
4.10.1 Premises used for activities described in these guidelines should be maintained in a clean condition.
规范中描述的厂房应该保持干净状态
4.10.2 Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting each product.
清洗，必要时要消毒以达到保护每个产品的目标
4.10.3 Cleaning and, if necessary, sanitizing agents to be used should be specified and effective.清洗试剂必要时消毒试剂
要有说明并是有效的
4.10.4 There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs of each area.
清洗消毒项目要符合各自区域的具体情况
4.11 Maintenance维护
Premises used in activities described in these guidelines should be maintained in a good state of repair.规范中描述的厂房
应保持在一个良好的维护状态
4.12 Consumables耗材
Consumables used for premises should not affect the quality of the product.
用于厂房维护的的耗材不能影响产品质量
4.13 Pest control虫害控制
4.13.1 Premises should be designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and other vermin.
厂房设计建造和和维护要能阻止昆虫，鸟儿，啮齿动物，虫害和其他害虫的进入。
4.13.2 There should be a pest control programme appropriate for the premises.
应有适合厂房建筑的虫害控制计划
4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests.
厂房外部区域要采取措施以避免吸引害虫。
5 Equipment设备
5.1 Principle原则
Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If automated systems are introduced into activities described in these guidelines, they should take into account the application of the given relevant principles.
设备应满足预期的目的，便于被清洗，必要时可以消毒和维护。本条例适合本规范里所有的设备，如果自动化系统
被引进在这个规范所提到的活动中，那么就要考虑相关条款的适用性。
5.2 Equipment design设备的设计
5.2.1 Production equipment should be designed to prevent contamination of the product.
选择、设计的生产设备类型需确保不会对产品产生污染。
5.2.2 Bulk product containers should be protected from air contaminants, such as dust and moisture.
散装产品的储存容器应防止空气污染物，如灰尘和水汽。
5.2.3 Transfer hoses and accessories that are not in use should be cleaned and, if necessary sanitized,kept dry and protected from dust, splash or other contamination.连接软管和配件不用时要清洁必要时消毒，保持干燥并防止灰尘水渍和其他
污染物的污染
5.2.4 The material used in the construction of equipment should be compatible with products and the cleaning and sanitizing agents.设备自身的材料不能和产品，清洗消毒试剂起反应
5.3 Installation安装
5.3.1 The design and the installation of equipment should ease its drainage in order to facilitate cleaning and sanitization.
设备的设计和安装要方便排水从而易于清洗消毒。
5.3.2 Equipment should be placed so that movement of materials, mobile equipment and personnel do not pose a risk to quality.
设备应放在不影响原料的转移，设备和人员移动的地方从而不会对产品质量产生风险。
5.3.3 Reasonable access under, inside and around equipment should be provided for maintenance and cleaning.
在设备的下面，里面和周围要有合理的空间以方便清洗消毒。
5.3.4 Major equipment should be readily identifiable.
主要设备能容易的被识别出来。
5.4 Calibration校准
5.4.1 Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly.
与生产、产品质量控制重要的实验和生产的测量设备，应被定期校准
5.4.2 If results of calibration are out-of-acceptance criteria, measuring instruments should be appropriately identified and removed from service
.如果校准结果超出标准，那么这个测量设备要被标识，并不能使用。
5.4.3 An out-of-calibration condition should be investigated to determine if there is any impact to the quality of the product
and appropriate steps taken based on this investigation.
需要分析超出校准的原因，以确定是否对产品质量造成影响，并且需要采取消除其影响的相应的措施。
5.5 Cleaning and sanitization清洗消毒
5.5.1 All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme.
所有设备需适合清洗消毒
5.5.2 Cleaning and sanitizing agents should be specified and effective.
清洗消毒试剂要有说明并且是有效的
5.5.3 Where equipment is assigned to continuous production or production of successive batches of the same product, equipment should be cleaned and, if necessary, sanitized at appropriate intervals.
如果设备被安排持续生产或同种产品的连续生产，应对其进行清洁，必要时在适宜的间隔进行消毒。
5.6 Maintenance维护保养
5.6.1 Equipment should be regularly maintained.
设备应定期保养
5.6.2 Maintenance operations should not affect the quality of the product.
保养项目不能影响产品质量
5.6.3 Defective equipment should be identified accordingly, excluded from use and isolated if possible
故障的设备应被标识并且不能再使用，如果可能进行隔离。
5.7 Consumables设备耗材
Consumables used for equipment should not affect the quality of the product.
用于设备的耗材不能影响产品质量
5.8 Authorizations使用授权
Equipment or automated systems used in production and control should be accessed and used by authorized personnel.设备或用在生产和控制的自动化系统应通过授权的人员访问和使用
5.9 Back-up systems系统备份
Adequate alternative arrangements should be available for systems which need to be operated in the event of a failure or breakdown.
当操作系统失败和故障时，适当的替代安排应可获得。
6 Raw materials and packaging materials原料和包材
6.1 Principle原则
Raw materials and packaging materials that are purchased should meet defined acceptance criteria relevant to the quality of finished products
采购的原料和包材要符合成品质量标准。
6.2 Purchasing采购
Purchasing of raw materials and packaging materials should be based on:
采购原料和包材时要建立在以下基础上
a) evaluation and selection of the supplier;对供应商的评估和选择
b) establishment of technical clauses such as type of selection to be conducted, acceptance criteria, actions in the case of defect or modifications, transport conditions;要制订技术文件，诸如：选择类型，接收准则，在出现缺陷的行动和修改，
运输状况等情况时所采取的相应措施（行动）。
c) setting of relations and exchanges between the company and supplier such as questionnaire, assistance and audits.建立公司和供应商之间的沟通、交流渠道，如通过问卷调查，协助和审核。
6.3 Receipt接收
6.3.1 The purchase order, the delivery note and the delivered materials should match
用于采购的订单号，送货单，运输的材料信息要匹配
6.3.2 The integrity of the raw materials and packaging materials shipping containers should be checked visually. If necessary, additional checks of transport data should be performed.
需检查运送原材料和包装材料的包装是否完整。必要时，检查传递的数据信息
6.4 Identification and status识别和状态
6.4.1 Containers of raw materials and packaging materials should be labelled in order to identify the material and the batch information
.盛放原料和包材的容器需被标识以能识别材料和批号信息
6.4.2 Raw materials and packaging materials showing defects that might affect product quality should be held pending a decision.
原料和包材如果有可能影响产品质量的缺陷应待定。
6.4.3 Raw materials and packaging materials should be identified in an appropriate way according to their status such as accepted, rejected or quarantined. Other systems can replace this physical system of identification, if they ensure the same level of assurance.
包材和原料应当标识接受，拒绝，待检状态，如果能达到相同的目的，其它识别系统也可以代替。
6.4.4 Identification of raw materials and packaging materials should contain the following information:
原料和包材识别应包含以下信息
a) name of the product marked on the delivery note;产品名称要标记在送货单上
b) name of the product as given by the company, if different from the name given by the supplier and/or its code number;
如果产品名称和供应商提供的不一样，工厂提供的产品名称。
c) date or number of receipt, if appr opriate;适宜时，接收日期和数量
d) supplier name;供应商名称
e) batch reference given by the supplier and the one given at receipt, if different.
注明供应商提供的批号和接受到的批号。（如果两者不同）
6.5 Release放行
6.5.1 Physical or alternative systems should be set up to ensure that only released raw materials and packaging materials are used.
应设置物理区域（仓库合格区存放区）或可选择的系统（识别状态系统），以确保只有批准放行的原材料和包装材
料才可以使用。
6.5.2 The release of materials should be carried out by the authorized personnel responsible for quality.
相关人员要对发放的原料和包材质量负责
6.5.3 Raw materials and packaging materials can be accepted on the basis of the supplier certificate of analysis only if there are established technical requirements, experience and knowledge of the supplier, supplier audit and agreed supplier test methods.
只有在建立了技术要求、供应商经验和知识、供应商审核和认可了供应商的测试方法时，审核原料和包材产品检测
证明接收才可以接受
6.6 Storage储存
6.6.1 Storage conditions should be appropriate for each raw material and packaging material.
储存条件要适合于原料和包材。
6.6.2 Raw materials and packaging materials should be stored and handled in a manner appropriate to their characteristics. 根据原料和包材的特性进行处理和储存
6.6.3 Specific storage conditions should be respected and monitored, where appropriate.
在适当情况下，具体的储存条件应当得到遵守和监控。
6.6.4 Containers of raw materials and packaging materials should be closed and should be stored off the floor.
包装原料和包材的容器应被封口并离地面储存。
6.6.5 When raw materials and packaging materials are repacked, they should carry the same labelling as at origin.
如果原料和包材被再次包装，其批号等信息要和最原始的保持一致。
6.6.6 When raw materials and packaging materials are quarantined or rejected, they should be stored in their respective physical locations or by using any other system providing the same level of assurance.
当原料和包材待检或拒绝，它们要被储存在各自的适合条件下，或者可以采用其它方法来处理，如果能达到相同效
果。
6.6.7 Measures should be set up to ensure stock turnover. Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.
应确保存货周转，除了特殊情况，要保证先进先出原则。
6.6.8 Periodic inventory should be performed to ensure stock reliability. Any significant discrepancy should be investigated and corrective action taken.
定期盘点时为了确保库存的可信度，任何重大的不符应被调查并采取纠正行动。
6.7 Re-evaluation重新评估
A system should be set up to re-evaluate materials as appropriate to determining their suitability for use, after a defined period of storage. The system should be set up so as to prevent the use of materials which require re-evaluation.
应建立体系以重新评估在储存一段时间后储存的物资是否可用。体系也应明确防止未重新评估就使用的情况
6.8 Quality of water used in production生产用水质量
6.8.1 The water treatment system should supply a defined quality of water.
水处理系统要提供符合质量要求的水
6.8.2 Water quality should be verified by either testing or monitoring of process parameters.
通过测试和过程参数的监测来核实水质
6.8.3 The water treatment system should permit sanitization.
水处理系统应消毒
6.8.4 Water treatment equipment should be set up so as to avoid stagnation and risks of contamination.
为了避免水停滞和污染的风险要具备水处理装备
6.8.5 Materials used in water treatment equipment should be selected to ensure that water quality is not affected.
用于水处理的材料要保证不能影响水质
7 Production生产
7.1 Principle原则
At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished product that meets the defined characteristics.
在生产和包装的每个过程，需采取一些措施确保成品达到要求。
7.2 Manufacturing operations制造作业
7.2.1 Availability of relevant documents相关文件的有效性
7.2.1.1 Relevant documentation should be available at each stage of manufacturing operations
相关文件在每个生产操作中是可行的
7.2.1.2 Manufacturing operations should be carried out according to manufacturing documentation,including:
根据相关文件进行下列操作：
a) suitable equipment;适合的设备
b) formula for the product;产品配方
c) list of all raw materials identified according to relevant documents indicating batch numbers and quantities;
根据相关文件指示的批号和数量，经确定的原料清单。
d) detailed manufacturing operations for each stage, such as addition of raw materials, temperatures, speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer.
生产过程的各个细节，如原料的添加、温度控制、转速、混合时间、抽样、清洗、必要时消毒设备、散装产品的转
移等。
7.2.2 Start-up checks生产前的检查
Before starting any manufacturing operations, it should be ensured that:生产前要确保：
a) all documentation relevant to the manufacturing operations is available;所有相关文件要到位
b) all raw materials are available and released;所有原料是可使用的并被放行。
c) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;设备可用并可以清洗和消
毒
d) clearance of the area has been performed to avoid mixing with materials from previous operations.上一个操作完毕后要
对所在区域进行清洁以避免交叉污染
7.2.3 Assignment of a batch number确定批号
A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number. 应指定散装产品的批号，虽然并不需要和成品上的批号完全相同，但应当与成品的批号相关联。
7.2.4 Identification of in-process operations过程操作的确认
7.2.4.1 In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers labelled with appropriate identification or directly into the equipment used for manufacturing.
根据配方，所有的原料都应被计量或称量，投入于干净适合的有适当标识的容器里或者直接投在生产设备当中。
7.2.4.2 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products.
在任何时候都需识别主要设备，盛原料和散装产品的容器。
7.2.4.3 Identification of containers of bulk products should indicate:盛散装产品的容器的标识：
a) name or identifying code;名称和识别码
b) batch number;批号
c) storage conditions when such information is critical to assure the quality of the product.当此信息对产品质量重要时标识储存条件
7.2.5 In-process control 过程控制
7.2.5.1 In-process controls and their acceptance criteria should be defined.
过程控制及其可接受准则应确定
7.2.5.2 In-process controls should be performed according to a defined programme.
过程控制要按确定的程序进行
7.2.5.3 Any result outside the acceptance criteria should be reported and appropriately investigated.
要报告任何超出规定的结果并做分析
7.2.6 Bulk product storage散装产品储存
7.2.6.1 Bulk product should be stored in suitable containers, in defined areas, and under appropriate conditions.
散装产品要储存在适合的容器内，特定的区域，适合的条件下。
7.2.6.2 The maximum bulk product storage duration should be defined.
设定散装产品最大储存有效期
7.2.6.3 When this duration is reached, the bulk product should be re-evaluated before use.
当达到有效期时，使用前需对散装产品进行再评估
7.2.7 Re-stocking raw materials原料再储存
If raw materials remain unused after weighing and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.
称量后未用的剩下原料返还到仓库时要被标识，并且盛装的容器要被封口和标识。
7.3 Packaging operations包装作业
7.3.1 Availability of documents相关文件的有效性
7.3.1.1 Relevant documentation should be available at each stage of packaging operations.
相关文件在每个生产操作中是可获得
7.3.1.2 Packaging operations should be carried out according to packaging documentation including:
根据相关文件进行操作，这些文件应包括：
a) suitable equipment;适合的设备
b) list of packaging materials defined for the intended finished product;用于包装成品的所有包材清单
c) detailed packaging operations such as filling, closing, labelling, and coding.详细的包装操作：诸如填充，封箱，标识
和喷码。
7.3.2 Start-up checks生产之前的检查
Before starting any packaging operation, it should be ensured that:在开始包装前要确保：
a) the area has been cleared of materials to avoid mixing with materials from previous operations; 上一个操作完毕后要对所在区域进行清线以避免混用。
b) all documentation relevant to the packaging operations, is available;有关包装的相关文件是可获得
c) all packaging materials are available;所有包装材料到位
d) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;使用了适合的设备，对要用到的设备进行清洗必要时进行了消毒
e) any coding to permit identification of the product is defined.要确定任何产品的识别码无误。
7.3.3 Assignment of batch number批号的确定
7.3.3.1 A batch number should be assigned to each unit of finished product.每组成品的批号要被确定
7.3.3.2 This number does not need to be identical with the batch number that appears on the label of the bulk product, but, if not, it should be easy to relate to that number. 每个产品要有批号，虽然并不需要和散装产品上的批号完全相同，但应
当与散装产品的批号相关联。
7.3.4 Packaging line identification包装生产线识别
At all times, it should be possible to identify the packaging line with its name or identifying code, the name or identifying
code of the finished product and the batch number.
在任何时候，可通过包装生产线的名称或识别码，成品名称、识别码或批号。
7.3.5 Checks of on-line control equipment在线监控设备的检查
If used, on-line control equipment should be regularly checked according to a defined programme.如果使用这样的设备，应根据相关文件对这些设备进行定期检查
7.3.6 In-process control过程控制
7.3.6.1 In-process controls and their acceptance criteria should be defined.制定过程控制的可接受准则
7.3.6.2 In-process controls should be performed according to a defined programme.
过程控制要按确定的程序进行
7.3.6.3 Any result that is outside the acceptance criteria should be reported and appropriately investigated.
报告超出准则的结果并分析
7.3.7 Re-stocking of packaging materials包材再储存
If packaging materials remain unused after packaging operations and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.
包装剩下的包材返还到仓库时要被标识，并且盛装的容器要被封口和标识。
7.3.8 Identification and handling of work-in-process在制品的标识和处理
Filling and labelling is usually a continuous process. Where this is not the case, special measures including segregation and identification should be applied so that no mix-ups or mislabelling can occur.
填充和贴标通常是一个连续的过程。如果不是，应使用特定的措施诸如阻隔和标识，以避免混贴和漏贴
8 Finished products成品
8.1 Principle原则
Finished products should meet the defined acceptance criteria.
成品应当满足确定的接受准则。
Storage, shipment and returns should be managed in a manner so as to maintain the quality of finished products.
用适当的方式对储存，装运，退回进行管理以保持成品的质量
8.2 Release放行
8.2.1 Prior to being placed on the market, all finished products should be controlled in accordance with established test methods and should comply with acceptance criteria.在产品投放市场前，所有成品应按规定检测合格。
8.2.2 Product release should be carried out by the authorized personnel responsible for quality.产品放行需要经过相关授权质量人员的批准。
8.3 Storage储存
8.3.1 Finished products should be stored in defined areas under appropriate conditions for an appropriate length of time. If necessary, finished products should be monitored while stored.
成品在特定区域，合适的条件储存一段时间，必要时要对其进行库存检查
8.3.2 Storage areas should permit organized storage.储存应当是有组织、有条不紊的。
8.3.3 When finished products are released, quarantined or rejected, they should be stored in their
respective physical locations or by using any other system providing the same level of assurance.
当成品被放行、隔离和拒绝时，它们要被储存在各自对应的存贮位置，或者可以采用其它方法来处理如果能达到相
同效果。
8.3.4 Identification of finished product containers should indicate: 盛装容器应包含以下信息
a) name or identifying code;名称和识别码
b) batch number;批号
c) storage conditions when such information is critical to assure the quality of the product;当储存条件对产品质量关键那就要标明。
d) quantity.数量
8.3.5 Measures should be set up to ensure stock turnover.建立确保库存周转的方法
Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.除了特殊情况，要保证先进先出原则
8.3.6 Periodic inventory checks should be performed to:定期盘点
a) ensure inventory accuracy;保证库存数据准确性
b) ensure that acceptance criteria are met.保证符合标准
Any significant discrepancy should be investigated. 要分析任何显著的异常情况
8.4 Shipment装运
Measures should be taken to ensure the shipment of the defined finished product.要采取措施来保证产品运输顺利。Precautions should be taken to maintain the finished product quality, when appropriate.必要时需采取预防措施来保证产品质量，（如防冻措施等）
8.5 Returns退回
8.5.1 Returns should be identified in an appropriate way and stored in defined areas.
退回的产品应适应标识并在特定区域贮存
INTERNATIONA STANDARD L国际标准ISO22716 First edition 2007-11-15 第一版本发行于 2007年11月15日 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices 化妆品—良好生产规范（GMP）准则 ISO 22716:2007(E) 标准号 ISO22716:2007(E)
Contents Page Introduction (1) 1 Scope (1) 2 Terms and definitions (1) 3 Personnel (4) 4 Premises (6) 5 Equipment (8) 6 Raw materials and packaging materials (10) 7 Production (11) 8 Finished products (14) 9 Quality control laboratory (15) 10 Treatment of product that is out of specification (17) 11 Wastes (17) 12 Subcontracting (18) 13 Deviations (19) 14 Complaints and recalls (19) 15 Change control (19) 16 Internal audit (20) 17 Documentation (20)
目录 介绍 (1) 1 范围 (1) 2 术语和定义 (1) 3 员工 (4) 4 厂房 (6) 5 设备 (8) 6 原料和包材 (10) 7 生产 (11) 8 成品 (14) 9 实验室质量控制制 (15) 10 不合格品的处理.......................................................... .17 11 废弃物 (17) 12 外包 (18) 13 偏差 (19) 14 投诉和召回 (19) 15 变更控制 (19) 16 内审 (20) 17 文档 (20)
碳钢弯头 Carbon Steel Elbow 不锈钢弯头 Stainless Steel Elbow 高压弯头 High-Pressure Elbow 同心异径管 Concentric Reducers 偏心异径管 Eccentric Reducers 高压异径管 High-pressure Reducers 不锈钢等径三通 Stainless Straight Tee 碳钢等径三通 Carbon Straight Tee 不锈钢等径四通 Stainless Straight Cross 高压三通 High-pressure Tee 锻制三通 Forged Tee 异径接头 Template 管帽 Caps 法兰flange 长径和短径弯头 long and short radius elbows 同心和偏心异径接头 concentric and eccentric reducers 等径和异径三通 straight and reducing outlet tees 大小头 CONCENTRIC REDUCER 相等的三通Tee Equal 等径三通Straight Tee 异径三通Reducing Tee 等径四通Straight Cross 90°短半径弯头90°SS Elbow(SR) U型管Return Bend
90°长半径弯头90°SS Elbow (LR) 高压厚壁弯头Thickness Elbow 盲法兰Blank Flange 弯管Bends 翻边stub ends 异径接头reducers 公称通径 nominal diameter 外径(mm) outside diameter 中心距至端面的距离 center to end 理论重量(kg/pcs) approx weight 类种description 标准Standard 类型Design 材质Material 双丝头 Nipple 同心异径短节 SWAGE Nipple 活接头 Union PLUG HEX HEAD六角管堵 PLUG HEX HEAD SCRD六角螺纹管堵 MPT螺纹 RC螺纹螺桩 stud SWAGE (CONC)同 心异径短节 单承口管箍 Half-Coupling 异径管箍Coupling, Reducing 盲板 Blind Flange 带双圈的盲板spectacle blind 偏心的Ecentric 等径直通equal coupling 内牙直通 female coupling 外牙直通 straight tube with outside 90等径弯头 90 equal elbow 45等径弯头 45 equal elbow
钟表中英文对照术语表，希望对各位表迷有所帮助 10J - 10天动力储备 Abbreviation for 10 days power reserve in the Patek Philippe typology.在百达翡丽而言是“10 days power reserve - 10天动力储备”的缩写。 24H - 24小时表盘 Abbreviation for "24-hour dial", in the Patek Philippe typology.在百达翡丽而言是“24-hour dial - 24 小时表盘”的缩写。 Amplitude - 摆幅
Measurement in degrees of the movement of a balance and spring assembly: amplitude is the angle between the position of equilibrium and its maximum elongation.测量摆轮游丝装置的摆动角度：摆幅即是游丝装置的平衡位置与最大距角之间的角度。 Analogue - 指针式时间显示 Refers to time display using hands.指采用指针来显示时间。 Aperture - 视窗、孔径
Dial opening revealing the indications provided on discs rotating under the dial.表盘上的开孔，可看见表盘下的转盘的显示信息。 Applique - 镶刻 Raised numeral or hour-marker, applied to or riveted to the dial. At Patek Philippe, appliques are always in gold and are sometimes diamond-set.固定在表盘上的凸起数字或时间刻度。百达翡丽钟表的镶刻通常用金打造，有时亦会镶嵌钻石。 Appropriage - 抛磨修整 An activity carried out by the Grand Complications workshop. The watchmakers themselves perform certain finishing operations such as polishing steel parts or
IPC标准中英名称对照 IPC-M-105 Rigid Printed Board Manual 刚性印制板设计手册 IPC-D-325A Documentation Requirements for Printed Boards 印制板设计文件图册要求 IPC-PE-740A Troubleshooting for Printed Board Manufacture and Assembly 印制板制造和组装的故障排除 IPC-6010 Series IPC-6010 Qualification and Performance Series IPC-6010印制电路板质量标准和性能规范系列手册 IPC-6011 Generic Performance Specification for Printed Boards 印制板通用性能规范 IPC-6013A Qualification & Performance Specification for Flexible Printed Boards (Includes Amendment 1) 挠性印制板的鉴定与性能规范（包括修改单1） IPC-6016 Qualification & Performance Specification for High Density Interconnect (HDI) Layers or Boards 高密度互连(HDI)层或印制板的鉴定与性能规范
IPC-6012A-AM Qualification and Performance Specification for Rigid Printed Boards, Includes Amendment 1 刚性印制板的鉴定与性能规范(包括修改单1) IPC-6018A Microwave End Product Board Inspection and Tech 微波成品印制板的检验和测试 IPC-6015 Qualification & Performance Specification for Organic Multichip Module (MCM-L) Mounting and Interconnections 有机多芯片模块(MCM-L)安装及互连结构的鉴定与性能规范 IPC-A-600F Acceptability of Printed Boards 印制板验收条件 IPC-QE-605A Printed Board Quality Evaluation Handbook 印制板质量评价 IPC-QE-605A-KIT Hard Copy and CD 印制板质量评价书和光盘(CD) IPC-HM-860 Specification for Multilayer Hybrid Circuits 多层混合电路规范 IPC-TF-870 Qualification and Performance of Polymer Thick Film Printed Boards 聚合物厚膜印制板的鉴定与性能 IPC-ML-960 Qualification and Performance Specification for Mass Lamination Panels for Multilayer printed Boards
管件标准中英文对照 Standard Code 规范代号 Standard Name 规范名称 ASME SA-234 中、高温用钢制碳钢和合金钢管道配件 Medium and high temperature used carbon and alloy steel pipe fittings ASME SA-420 低温用锻制碳钢和合金钢管配件 Low temperature forged carbon and alloy steel pipe fittings ASME SA-403 锻制奥氏体不锈钢管配件 Forged Durimet pipe fittings ASME B16.9 工厂制造的钢制对焊管件 Factory-Made wrought steel pipe fittings ASME B16.11 承插焊和螺纹锻钢管件 Socket-welding and Threaded forged fittings ASME B16.28 锻钢对焊小半径弯头和回弯头 Wrought steel butt-welding short radius elbows and returns ISO 5251 不锈钢对焊管件 Stainless steel butt-welding fittings MSS SP-43 锻制不锈钢对焊管件 Wrought stainless steel butt-welding fittings MSS SP-75 锻钢制对焊管件 Forging butt-welding fittings MSS SP-79 承插焊异径插入件 Socket-welding reducing Inserts MSS SP-83 3000磅级的钢制承插焊和螺纹活接头 Class 3000 steel socket-welding and threaded unions MSS SP-95 缩渐管和圆堵头 Swaged nipples and round plugs MSS SP-97 承插焊、螺纹和对焊端的整体加紧式管座 SW 、TH and BW ends for integrally reinforced forged branch outlet JIS B2311 通用钢制对焊管件 Universal steel butt-welding pipe fittings JIS B2312 钢制对焊管件 Steel butt-welding pipe fittings JIS B2313 钢板制对焊管件 Steel plate butt-welding pipe fittings JIS B2316 钢制承插焊管件 Steel socket-welding pipe fittings DIN 2605 钢制对焊管件弯头和弯管 Steel butt-welding pipe fittings.elbows and bends DIN 2615 钢制对焊管件三通 Steel butt-welding pipe fittings.tees DIN 2616 钢制对焊管件异径管 Steel butt-welding pipe fittings.reducers
常用机床术语中英文对照 机床中英文对照表 （您可以使用CTRL+F来查找） （1）：按英文字母排序 3-Jaws indexing spacers 三爪、分割工具头 A.T.C.system 加工中心机刀库 Aluminum continuous melting & holding 连续溶解保温炉furnaces Balancing equipment 平衡设备 Bayonet 卡口 Bearing fittings 轴承配件 Bearing processing equipment 轴承加工机 Bearings 轴承 Belt drive 带传动 Bending machines 弯曲机 Blades 刀片 Blades,saw 锯片 Bolts,screws & nuts 螺栓,螺帽及螺丝 Boring heads 搪孔头 Boring machines 镗床 Cable making tools 造线机 Casting,aluminium 铸铝 Casting,copper 铸铜 Casting,gray iron 铸灰口铁 Casting,malleable iron 可锻铸铁 Casting,other 其他铸造 Casting,steel 铸钢 Chain drive 链传动
Chain making tools 造链机 Chamfer machines 倒角机 Chucks 夹盘 Clamping/holding systems 夹具/支持系统 CNC bending presses 电脑数控弯折机 CNC boring machines 电脑数控镗床 CNC drilling machines 电脑数控钻床 CNC EDM wire-cutting machines 电脑数控电火花线切削机CNC electric discharge machines 电脑数控电火花机 CNC engraving machines 电脑数控雕刻机 CNC grinding machines 电脑数控磨床 CNC lathes 电脑数控车床 CNC machine tool fittings 电脑数控机床配件 CNC milling machines 电脑数控铣床 CNC shearing machines 电脑数控剪切机 CNC toolings CNC刀杆 CNC wire-cutting machines 电脑数控线切削机Conveying chains 输送链 Coolers 冷却机 Coupling 联轴器 Crimping tools 卷边工具 Cutters 刀具 Cutting-off machines 切断机 Diamond cutters 钻石刀具 Dicing saws 晶圆切割机 Die casting dies 压铸冲模 Die casting machines 压铸机 Dies-progressive 连续冲模 Disposable toolholder bits 舍弃式刀头 Drawing machines 拔丝机
1.2 管件 Fitti ng 弯头elbow 异径弯头 reducing elbow 带支座三通 base tee 异径三通（一个直通口及分支口为异径） reduc ing tee (reduc ing on one run and outlet) 异径三通（两个直通口为异径，双头式） head ） 45 ° 斜三通 45 ° lateral reduc ing tee (reduc ing on both runs, bull 45 ° 斜三通(支管为异径) 45 ° lateral (reduci ng on bran ch) 45 ° 斜三通(一个直通口为异径 )45 ° lateral (reducing on one run) 45 ° 斜三通(一个直通口及支管为异径 )45 ° lateral (reducing on one run and branch) 四通cross （一个直通口及两个分支口为异径） both outlet ） 异径管reducer reduc ing cross (reduc ing on one run and 螺纹支管台 threadolet 等径四通 straight cross 异径四通 reduc ing cross 异径四通 （一个分支口为异径） reduc ing cross (reduc ing on one outlet) 异径四通 outlet ） 异径四通 （一个直通口及分支口为异径） reduc ing cross (reduc ing on one run and （两个分支口为异径） reduc ing cross (reduc ing on both outlet) 同心异径管 concen tric reducer 偏心异径管 ecce ntric reducer 锻制异径管 reduc ing swage 焊接支管台 weldolet 带支座弯头 base elbow k 半径弯头 long radius elbow 短半径弯头 short radius elbow 长半径180 短半径180 ° 弯头 long radius return ° 弯头 short radius return 带侧向口的弯头（右向或左向） side outlet elbow (right hand or left hand) 双支管弯头（形） double branch elbow 三通tee 异径三通 reducing tee 等 径三通straight tee 带侧向口的三通（右向或左向） side outlet tee (right hand or 1eft hand) 异径三通（分支口为异径） reduc ing tee (reduc ing on outlet) 异径三通（一个直通口为异径） reduc ing tee (reduc ing on one run) Y 型三通（俗称裤衩） true “ Y” 异径四通
常见工程咨询中英文对照 问题：客户未告知采用什么标准进行制作与检查。 建议：我们按IPC-6012B Class2与IPC-A-600G Class2 做。 Question 1: Customer doesn’t tell us what standards we should take to manufacture and inspect. Suggestion: We will follow IPC-6012B Class2 &IPC-A-600G Class2. 问题：客户未告知板料类型。 建议：我们将使用FR4． Question: Customer doesn’t tell us material type. Suggestion: We will use FR4. 问题：客户要求成品厚度为1.60+/-0.10mm，此公差对六层板而言太紧，难以控制。 建议: 将公差放松到+/-0.15mm. Question: Customer requires “1.60+/-0.10mm” finished board thickness, the tolerance is too tight for six -layer board., it’s hard to control for us. Suggestion: Relax the tolerance to be +/-0.15mm. 问题：客户未规定使用何种类型的阻焊油及颜色。 建议: 我们采用普通感光绿色湿油. Question: Customer doesn’t specify solder mask type and color. Suggestion: We use normal green LPI. 问题：客户未指定UL 标记与Date code加于何处及以何种方式显示。 建议：见下图，我们将其加于TOP面，以白字显示。 Question: Customer doesn’t specify where and by what display form we should add UL logo and date code. Suggestion: See below picture, we add them on top side and display them by silk letters. 问题：客户要求线路表面油厚为30um min，线路拐角位为20um min，此要求太高。 建议: 线路油表面厚与线路拐角位油厚分别放松到15um min 与10um min. Question: Solder mask is required to be 30um min over line and 20um min at corners, it’s too strict. Suggestion: Relax it to be 15um min over line and 10um min at corners, 问题：客户未规定镍金厚度要求。 建议：我们按镍厚2.54um min,金厚0.03—0.08um制作. Question: Customer doesn’t specify thickness of Ni and gold. Suggestion: Ni: 2.54um min and gold: 0.03---0.08um. 问题：客户未清楚指明层序。 建议：层序为： Question: Customer doesn’t indicate layer sequence. Suggestion: Layer sequence is 问题：客户未规定压板结构。 建议：按下图所示做。 Question: Customer doesn’t specify lay-up structure. Suggestion: Follow below picture to do.
这个是用来表达管件连接形式的；给楼主一份中英文对照还有缩写吧缩写中文名称英文名称 P 管子Pipe EL 弯头Elbow ELL 长半径弯头Long radius elbow ELS 短半径弯头Short radius elbow MEL 斜接弯头（虾米腰弯头）Mitre elbow REL 异径弯头Reducing elbow T 三通Tee LT 斜三通Lateral tee RT 异径三通Reducing tee R 异径管接头（大小头）Reducer CR 同心异径管接头（同心大小头）Concentric reducer ER 偏心异径管接头（偏心大小头）Eccentric reducer CPL 管箍Coupling FCPL 双头管箍Full coupling HCPL 单头管箍Half coupling RCPL 异径管箍Reducing coupling BU 内外螺纹接头Bushing UN 活接头Union HC 软管接头Hose coupler SE 翻边短节Stub end
NIP 短节Pipe nipple or straight nipple SNIP 异径短节Swaged nipple CP 管帽（封头）Cap PL 管堵（丝堵）Plug BLK 盲板Blank SB 8字盲板Spectacle blind （blank）RP 补强板Reinforcing pad 法兰 缩写中文名称英文名称 PLG 法兰Flange WNF 对焊法兰Welding neck flange SOF 平焊法兰Slip-on flange SWF 承插焊法兰Socket-welding flange T 螺纹法兰Threaded flange LJ 松套法兰Lapped joint flange REDF 异径法兰Reducing flange BF 法兰盖（日法兰）Blind flange FSF 法兰密封面Flange scaling face FF 全平面Flat face RF 凸台面Raised face MFF 凹凸面Male and female face LF 凹面Female face
语文课程与教学论 名词术语中英文对照表 the Chinese Course and Teaching and Learning Theory in Chinese and English Teaching materials editing teaching materials /Chinese Teaching Materials /edit teaching materials /Uniformed Chinese Teaching Materials /Experimental Teaching Materials /Mother Tongue Teaching Materials /Teaching Materials of the New Course *textbook *reading book *teaching reference book *exercises book *studying plan Technology /Educational Technology /Modern Educational Technology /Educational Technology in Chinese Teaching /multi-media technology /net technology /cloud serving technology *white board *net meeting *chat room *blog Teaching Basic Theory of the Teaching teaching aim teaching task teaching objective teaching model teaching tactics teaching principle teaching program teaching reform teaching case Courseware teaching resources teaching experiment /mother tongue teaching A Term List of 1. 教材（ JC ） 教材编写 /语文教材 /编写教材 / 统编教材 /实验教材 /母语教材 /新课程教材 * 课本 * 读本 * 教学参考书（教参） * 练习册 *学案 2. 技术（ JS ） / 教育技术 /现代 教育技术 /语文 教育技术 /多媒 体技术 / 网络 技术 /云服务技 术 * 白板 *网 络会议 *聊天室 * 博克 3. 教学 （JX ） 教学基本理论 教学目的 教学 任务 教学目标 教学模式 教学 策略 教学原则 教学大纲 教学 改革 教学案例 教学课件 教学 资源 教学实验 /母语教学
IPC-A-610国际标准中英文对照 4.6.2 Heat sink-Contact 散热片――接触片 arget-Class 1,2,3 目标——等级1,2,3 · Component and heatsink are in full contact with the mounting surface. 组件和散热片与安装表面完全 接触 · Hardware meets specified attachment requirements. 部件满足规定的接触要求。 Figure图4-64 1. Heat sink 散热片 Acceptable-Class 1,2,3 可接受的——等级1,2,3 · Component not flush. 组件不平齐 · Minimum 75% contact with mounting surface. 至少有75%与安装表面接触 · Hardware meets mounting torque requirements if specified. 如果有规定，部件满足安装的转距要求
Figure图4-65 1. Gap 2. Heat sink 间隙散热片 Defect-Class 1,2,3 缺点——等级1,2,3 · Component is not in contact with mounting surface. 组件没有接触到安装表面 · Hardware is loose and can be moved. 部件松弛可以移动。 Figure图4-66 1. Heat sink 2. Gap 散热片间隙
5.1 Orientation 方向 5.1.1 Orientation-Horizontal 方向——水平 Target-Class 1,2,3 目标——等级1，2，3 ?Components are centered between their lands. 组件位于焊盘中央 ?Component markings are discernible. 组件标识清晰可见 ?Nonpolarized components are oriented so that markings all read the same way (left-to-right or top-to-bottom). Figure图5-1 无极性组件的方向应使其标识 都能按同样方式进行辨识 （从左到右或从上到下） Acceptable-Class 1,2,3 可接受的——等级1，2，3 ?Polarized and multilead components are oriented correctly. 有极性和多引脚的组件应按正确 方向安装。 ?When hand formed and hand-inserted, polarization symbols are discernible. 当手工成型及手插件时，极性符号可以辨识。 ?All components are as specified and terminate to Figure图 5-2 correct lands.
Terms of payment: 支付条款 D/A: (documents against acceptance)商业单据是凭承兑交单交付款人,是指出口人的交单以进口人在汇票上的承兑为条件。 D/P: (documents against payment) 商业单据是凭付款交单交付款人,是指出口人的交单是以进口人的付款为条件。Down Payment: 首期付款 Irrevocable Letter of Guarantee: 不可撤销保证函 Pro forma invoice: 形式发票 Documentary L/C: 跟单信用证，是开证行凭跟单汇票或仅凭单据付款的信用证。 Clean L/C: 光票信用证，是开证行凭不附单据的汇票付款的信用证。 Bills of Lading(B/L): 提单 Compensation: 赔偿金 Process unit: 工艺设备 Delivery and terms of delivery: 交货及交货条款 General provisions: 一般规定 Components: 组件 Implementation: 履行，落实 Container vessel: 集装箱船 Incorporated parts: 配套件
DDP: 完税后交货 Packing and marking: 包装与标记 Design liaison and design review: 设计联络与设计总览Standards and inspection: 标准与检验 Erection, commissioning, and acceptance: 安装，调试与验收Liquidated damages and claims: 损失和赔偿金 Force majeure clauses: 不可抗力条款 Demurrage: 滞留费，滞留 Arbitration: 仲裁 Patent infringement, secrecy, licence: 专利侵权，保密，执照Termination for default: 违约终止 Coming into force: 合同生效 Miscellaneous: 其他事项 Contract amendments: 合同修订 Assignment and subcontract: 分配与分包 Termination for insolvency: 破产终止 Performance bond: 履约保证金 Change orders: 变更通知书 Governing language and unit of measurement: 合同语言与测量单位 Correspondence: 信件 Limitation of liability: 责任限制
弯头 elbow 异径弯头reducing elbow 带支座弯头base elbow 长半径弯头（标准 1.5 倍弯曲半径 ---1.5D ） long radius elbow 三通 tee 异径三通 reducing tee 等径三通 straight tee 带侧向口的三通（右向或左向） side outlet tee （right hand or 1eft hand）异径三通（分支口为异径）reducing tee （reducing on outlet）异径三通（一个直通口为异径）reducing tee （reducing on one run）带支座三通base tee 异径三通（一个直通口及分支口为异径）reducing tee （reducing on one run and outlet）异径三通（两个直通口为异径，双头式）reducing tee （reducing on both runs, bull head） 45 °斜三通 45 °lateral 45 °斜三通（支管为异径）45 °lateral （reducing on branch）45 °斜三通（一个直通口为异径）45 °lateral （reducing on one run） 45 °斜三通（一个直通口及支管为异径）45 °lateral （reducing on one run and branch） Y 型三通（俗称裤衩） true “ Y” 四通 cross 等径四通straight cross 异径四通reducing cross 异径四通(一个分支口为异径) reducing cross (reducing on one outlet) 异径四通(一个直通口及分支口为异径) reducing cross (reducing on one run and outlet) 异径四通(两个分支口为异径) reducing cross (reducing on both outlet) 异径四通(一个直通口及两个分支口为异径) reducing cross (reducing on one run and both
管件中英文对照表 1、法兰Flange(FLG）整体管法兰integral pipe flange 钢管法兰steel pipe flange 螺纹法兰threaded flange 滑套法兰（包括平焊法兰）slip-on flange(SO);slip-on welding flange 承插焊法兰socket welding flange 松套法兰lap joint flange(LJF) 对焊法兰welding neckflange(WNF) 法兰盖blind flange,blind 孔板法兰orifice flange 异径法兰reducing flange 盘座式法兰pad type flange 松套带颈法兰loose hubbed flange 焊接板式法兰welding plate flange 对焊环welding neck collar（与stub end相似） 平焊环welding-on collar 突缘短节stub end,lap 翻边端lapped pipe end 松套板式法兰loose plate flange 压力级pressure rating,pressure rating class 压力—温度等级pressure-temperature rating 法兰密封面，法兰面flange facing 突面raised face(RF) 凸面male face(MF) 凹面female face(FMF) 榫面tongue face 槽面groove face 环连接面ring joint face 全平面；满平面flat face;full face(FF) 光滑突面smooth raised face(SRF) 法兰面加工facing finish 粗糙度roughness 光滑的smooth 齿形serrated 均方根root mean square(RMS) 算术平均粗糙高度arithmetical average roughness height(AARH) 配对法兰companion-flange 螺栓圆bolt circle(B.C.)
PCB内存条检验标准 1.Purpose目的 Setting up a spec of PCB for memory module product. 制定内存产品规格. 2.Scope范围 This spec is applied to the PCB for normal memory module product. 这规格应用于内存条产品. 3.Reference Document参考文献 1>PCB working direction(HEI standard) HEI标准PCB工作指引 2>JEDEC spec:JEDEC spec.M0-064 JEDEC标准:JEDEC spec.M0-064 3>IPC spec:IPC-A-600 IPC spec:IPC-A-600 4.Equipment & Materials:Not required仪器和材料:不要求 5.Calibration:Not required仪校:不要求 6.Records & Forms:Not required记录和格式:不要求 7.Safety安全性 1>Materials have to be stored in a appointed place. 产品必须储存在许可的地方. 2>It should be handled carefully for safety. 搬运必须考虑其产品的安全性.
8.Definition定义 1>PCB:a composite of organic and inorganic material,with external and internal conducting or low-resistivity paths that allow mechanical support and electrical connection of components.(Printed Circuit Board) 印刷线路板 2>Tab:It connects electrical signal between memory module and system 金手指:连接记忆模块和系统间电子信号 3>Via hole:An hole that provides an electrical pathway from one metal layer to the metal layer above or below 过孔:导通孔。用于印制板不同层中导线之间电气互连的一种镀覆孔。 4>Land:a circle copper which surrounds the via hole 孔环:过孔孔环-连接盘。 5>Solder Resist:Solder mask is applied to protect and insulate the circuitry both during subsequent soldering and in the environment 防焊阻剂:绿油 6>Discoloration:the change in color of any plated metallization. 变色:金属化镀层色差 7>Copper Island(Copper residue):Copper that exists out of circuit 残铜:线间弧岛残铜 8>Undercut:the lateral etching into a substrate under a resistant coating,as at the edge of a resist image(→overcut) 侧蚀(过蚀) 9>X-out:An inferior piece of PCB 报废PCS