C90 制药、安全机械与设备综合 标准查询与下载

EN 13200-8:2017 观众设施-第8部分:安全管理

This European Standard specifies general characteristics of safety management in spectator facilities. It specifies the layout and the planning of the management, the criteria to maintain this planning before, during and after any event. It covers the following: - the safety personnel; - safety policy; - safety procedures. This European Standard does not apply to the roles and responsibilities of those who are part of the security system (police and security companies).

Spectator facilities - Part 8: Safety Management

ASTM E3077-17e1 材料供应商向制药和生物制造制造商传送原材料电子数据的标准指南

5.1 Application of the approach described within this guide is intended to achieve a biopharma industry-wide standard format that will be available for electronic data transfer between Supplier and Customer for monitoring and studying variability. 5.2 This guide supports and facilitates fast data transfer, thereby avoiding data recapture, human interaction, and transcription errors; and thus enables a more streamlined business process. 5.3 If the eData structure does not conform to the XSD defined by this guide then it is not guaranteed to be inter-operable. Feedback or change requests should be directed to ASTM Headquarters, to the attention of the Committee E55 Staff Manager. 5.4 Digital Signature can be adopted and used as part of the eData transfer. XML and XSD are provided in two formats: with and without digital signature configuration. User can follow either format for implmenation to ensure conforming with the ASTM eData XSD structure. 1.1 This guide is applicable to all elements of raw material electronic data (eData) transfer from a Supplier which provides a raw material to a Customer which receives the raw material. 1.2 This guide is developed for pharmaceutical and biopharmaceutical manufacturers and their suppliers, but may be suitable for other industries that routinely transfer data. 1.3 The guide may also be applicable to raw material eData transfer between companies in the supply chain. 1.4 The guide is applicable to new and existing raw materials. 1.5 This guide is applicable to the life-cycle of a raw material (that is, data generated throughout the processing stages of the raw material) and is not dependent on the Supplier or Customer. 1.6 This guide describes two major areas of eData standard: the data format and the data content including the taxonomy and nomenclature. 1.7 The guide currently only covers data content and data format in the English language. The data format shall not be translated. Use of other languages for the data content outside the scope of this guide. 1.8 The format is based on Extensible Markup Language (XML) 1.0. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

DIN EN ISO 13408-6:2013 医疗保健产品的无菌加工.第6部分:隔离器系统(ISO 13408-6-2005+Amd 1-2013).德文版本EN ISO 13408-6-2011+A1-2013

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013); German version EN ISO 13408-6:2011 + A1:2013

ANSI/NCPDP 2013101-2013 NCPDP专业标准2013101

NCPDP Specialized Standard 2013101

ANSI/NCPDP MRv 06.01-2013 NCPDP制造商折扣利用,计划,规定的,市场购物篮和调和平面文档标准v06.01-201x

NCPDP Manufacturer Rebate Utilization, Plan, Formulary, Market Basket, and Reconciliation Flat File Standard v06.01-201x

ANSI/NCPDP SC2013101-2013 NCPDP脚本标准2013101

NCPDP SCRIPT Standard 2013101

BIP 0113-2012 BS EN ISO 14155标准和欧洲医药设备试验指南

Guide to European Medical Device Trials and BS EN ISO 14155

BS ISO 18084:2011 药品的冲压工具.冲压机和模具

Press tools for tablets. Punches and dies

DIN EN ISO 22413:2011 药物制备用输送装置.试验方法和要求(ISO 22413-2010).德文版本EN ISO 22413-2011

This Internatioanl Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010); German version EN ISO 22413:2011

EN 1175-3:1998+A1:2010 工业卡车的安全性.电气要求.第3部分:内燃机驱动的电动卡车的电力传输系统的具体要求

This standard specifies the safety requirements for the design and construction of electrical power transmission systems of trucks with internal combustion engines driving one or more generators with outputs up to and including 600 V supplying power to function motors. The Annex A is normative and contains "Generators - Output and test rules". NOTE 1 Reference is made to this standard in other standards which cover the non-electrical requirements of the various industrial truck types. NOTE 2 The special requirements for operation in potentially explosive atmospheres are not covered in this European Standard. The requirements of this standard are applicable, when trucks are operated under the following climatic conditions: Maximum ambient temperature, continuous duty: +40°C; Lowest ambient temperature: -20 °C; Service altitude: up to 2000 m; Relative humidity: in the range 30 % to 95 % (non condensing). This standard covers specific hazards which could occur during the intended use of trucks. For hazards occurring during construction, transportation, commissioning, decommissioning and disposal, reference should be made to EN ISO 12100-2:2003.

Safety of industrial trucks - Electrical requirements - Part 3: Specific requirements for the electric power transmission systems of internal combustion engine powered trucks

EN 1175-1:1998+A1:2010 工业卡车的安全性.电气要求.第1部分:电池动力卡车的一般要求

This standard specifies electrical and related mechanical safety requirements for design and construction of the electrical installation in battery powered industrial trucks hereinafter referred to as trucks, with nominal voltages of the truck system up to 240 V. The Annex A is normative and gives requirements for "Connectors for traction batteries". Annex B is normative and contains "Electric motors - Output and test rules" and Annex C is normative and contains "Electromagnetic contactors". NOTE 1 Reference is made to this standard in other standards which cover the non-electrical requirements of the various industrial truck types. NOTE 2 This standard does not address the subject of charging of traction batteries (CENELEC TC 21X is preparing safety standards for battery charging). NOTE 3 The special requirements for operation in potentially explosive atmospheres are not covered in this European Standard. The requirements of this standard are applicable, when trucks are operated under the following climatic conditions: Average ambient temperature for continuous duty: +25°C; Maximum ambient temperature, short term (up to 1 h): +40°C; Lowest ambient temperature for trucks intended for use in normal indoor conditions: +5 °C; Lowest ambient temperature for trucks intended for use in normal outdoor conditions: -20 °C; Altitude: up to 2000 m; Relative humidity: in the range 30 % to 95 % (non condensing). This standard covers specific hazards (listed in clause 4), which could occur during the intended use of trucks. For hazards occurring during construction, transportation, commissioning, decommissioning and disposal, reference should be made to EN ISO 12100-2:2003.

Safety of industrial trucks - Electrical requirements - Part 1: General requirements for battery powered trucks

EN 1175-2:1998+A1:2010 工业卡车的安全性.电气要求.第2部分:内燃机驱动的卡车的一般要求

This standard specifies the electrical and related mechanical safety requirements for the design and construction of the electrical installation in internal combustion engine powered trucks (hereinafter referred to as "trucks") with starter battery nominal voltages up to and including 24 V. NOTE 1 Part 3 of this standard details specific electrical requirements for electrical power transmission systems of internal combustion engine powered trucks. NOTE 2 Reference is made to this standard in other standards which cover the non-electrical requirements of the various industrial truck types. NOTE 3 The special requirements for operation in potentially explosive atmospheres are not covered in this European Standard. The requirements of this standard are applicable, when trucks are operated under the following climatic conditions: Maximum ambient temperature, continuous duty: +40°C; Lowest ambient temperature: -20 °C; Service altitude: up to 2000 m; Relative humidity: in the range 30 % to 95 % (non condensing). This standard covers specific hazards which could occur during the intended use of trucks. For hazards occurring during construction, transportation, commissioning, decommissioning and disposal, reference should be made to EN ISO 12100-2:2003.

Safety of industrial trucks - Electrical requirements - Part 2: General requirements of internal combustion engine powered trucks

EN 13675:2004+A1:2010 机械安全.管成型和轧钢厂和他们的精整线设备的安全要求

This European Standard describes the health and safety requirements of fully automated plant used in the process of tube forming, rolling and finishing (hereafter referred to as "plant"). It describes the foreseeable, significant hazards, hazardous situations, and events arising from plants and from particular machines integrated to form the plant; it does not describe the full health and safety requirements for each particular machine. It indicates preventive measures for avoiding the hazards and reducing the risks. It deals not only with circumstances where the machinery is used as intended, but also includes other conditions foreseen by the manufacturer, such as foreseeable faults, malfunctions or misuse. This European Standard specifies the requirements to ensure the safety of persons which are to be met during the design, assembly, transport, commissioning, operation, maintenance and decommissioning of the equipment. This standard assumes that installations are operated and maintained by adequately trained and competent personnel. Manual intervention for setting, adjustment and maintenance is accepted as part of the normal use of these machines. This standard assumes that the machinery is used with adequate workplace lighting conforming to EN 12464-1 or to local regulations. This standard applies to: Automated plant and equipment operated for the production of metal seamless hot and cold finished tubes and welded tubes. A list of machines which could make up different plants is shown in Annex D (informative). This standard covers: For seamless hot-finished tubes: from material charging downstream of the heating furnace through the rolling process and up to, but not including any intermediate storage equipment or the downstream finishing lines. For seamless cold-finished tubes: from material charging through the rolling process to the discharging equipment but not including any storage equipment. For welded tubes: from coil charging through strip preparation, forming and welding equipment up to, but not including any intermediate storage equipment or the downstream finishing lines. For the tube finishing line: from tube charging to the discharging equipment to the storage. The following items are outside the scope of this standard: complete risk assessment of single machines which are used to form a plant furnaces; quenching equipment; spiral tube manufacture; large diameter tube welding manufacture using three-roll bending machines, U-ing and O-ing press lines and their finishing lines; butt welding machinery for the manufacture of endless strips; irradiation units (material testing by e. g., ultrasonic and X-ray testing units); centrifugal casting machines; machine tools used for e. g., threading, chamfering, stamping and marking machines; storage equipment. This standard does not establish any requirements concerning electromagnetic disturbances. This standard is not applicable to tube rolling and forming mills and finishing line equipment, manufactured before the date of publication of this standard by CEN. NOTE The words "Tube" and "Pipe" are synonymous in this standard.

Safety of machinery - Safety requirements for tube forming and rolling mills and their finishing line equipment

EN 1034-4:2005+A1:2009 机械安全.造纸及整理机的设计和施工的安全要求.第4部分:碎浆机和装载工具

This European Standard applies to pulpers and their loading facilities intended for use in paper making and shall be used together with EN 1034-1:2000+A1:2010. It deals with all significant hazards, hazardous situations and hazard events relevant to pulpers and their loading facilities, when they are used as intended and under the conditions foreseen by the manufacturer (see clause 4). This European Standard is not applicable to pulpers and their loading facilities that have been manufactured before the date of publication of this standard.

Safety of machinery - Safety requirements for the design and construction of paper making and finishing machines - Part 4: Pulpers and their loading facilities

EN 1034-5:2005+A1:2009 机械安全.造纸及整理机的设计和施工的安全要求.第5部分:切纸机

This European Standard applies to sheeters, including unwinding units, sheet stacker, drive and control units intended for use in paper making and shall be used together with EN 1034-1:2000+A1:2010. Paper dust and edge strip suction devices are not covered by this standard. It deals with all significant hazards, hazardous situations and hazard events relevant to sheeters, when they are used as intended and under the conditions foreseen by the manufacturer (see clause 4). This standard does not apply to: sheeters for corrugated board (see EN 1010-5); sheeters for foil (see EN 1010-1); sheeters with sheet feeders (see EN 1010-1); guillotines (see EN 1010-3:2002). This document is not applicable to sheeters that have been manufactured before the date of publication of this document by CEN.

Safety of machinery - Safety requirements for the design and construction of paper making and finishing machines - Part 5: Sheeters

EN 1034-6:2005+A1:2009 机械安全.造纸及整理机的设计和施工的安全要求.第6部分:压延机

This European Standard applies to calenders intended for use in paper making and finishing and shall be used together with EN 1034-1:2000+A1:2010. It deals with all significant hazards listed in clause 4. Related safety requirements and/or measures are described in clause 5. It does not cover hazards connected with lifting operations required for changing rolls, inserting reels into the unwinding unit, removal of reels from the winding unit and heating systems for heating calender rolls. This European Standard is not applicable to calenders that have been manufactured before the date of publication of this standard.

Safety of machinery - Safety requirements for the design and construction of paper making and finishing machines - Part 6: Calender

EN 1034-14:2005+A1:2009 机械安全.造纸和整理机的设计和施工的安全要求.第14部分:卷筒分离器

This European Standard applies to reel splitters intended for use in paper making and shall be used together with EN 1034-1:2000+A1:2010. It deals with all significant hazards, hazardous situations and hazardous events relevant to reel splitters when used as intended and under the conditions reasonably foreseen by the manufacturer as incorrect application (see clause 4). This European Standard applies only to reel splitters with a movable knife and of the following designs: machines with a vertically moving knife pressed downwards from the top onto the reel, generally right to the core so that the layers of wound paper are separated one after the other and fall off; machines with a driven and movable circular knife that cuts the wound layers of the horizontal reel successively, beginning from the top down to the core, with the cut layers of wound paper falling off one after the other. This European Standard also applies to the integrated conveyor belts and the integrated pivoting platform. This European Standard also covers the guard rails at the interface of the reel splitter and a pulper that is charged with an integrated conveyor belt of the reel splitter. NOTE Pulpers are dealt with in EN 1034-4. This European Standard is not applicable to reel splitters which are manufactured before the date of publication of this EN.

Safety of machinery - Safety requirements for the design and construction of paper making and finishing machines - Part 14: Reel splitter

JB/T 20126-2009 超声提取设备.术语和超声性能试验方法

本标准规定了超声提取设备的术语和定义，以及超声性能试验方法。 本标准适用于采用压电型夹心换能器的超声提取设备。

Ultrasonic extraction machinery terms and test methods for ultrasonic properties

EN 12717:2001+A1:2009 机床安全性.打孔机

This standard specifies the technical safety requirements and measures to be adopted by persons undertaking the design, construction and supply (including installation and dismantling, with arrangements for transport and maintenance) of stationary drilling machines (see 3.1). This standard covers both manual and automatic drilling machines. These include but are not limited to: pedestal drilling machines (see figure A.1); radial arm drilling machines (see figure A.2); coordinate table drilling machines (see figure A.3); horizontal spindle drilling machines (see figure A.4); multi-spindle drilling machines (see figure A.5) turret type drilling machines with manual control of turret index. This standard takes account of intended use including reasonably foreseeable misuse, maintenance, cleaning, and setting operations. It presumes access to the machine from all directions. It describes means to reduce risks to operators and other exposed persons. This standard also applies to workpiece transfer devices when they form an integral part of the machine. This standard deals with significant hazards relevant to drilling machines when they are used as intended and under the conditions foreseen by the manufacturer (see clause 4). Hazards arising from other metal working processes (e. g. milling, grinding, turning, forming, EDM, laser processing) are covered by other standards (see Bibliography). Automatic drilling machines with automatic tool changing capabilities are not covered by this standard (see prEN 12417:1996). This standard is not applicable to drilling machines, which were manufactured before the date of publication by CEN of this standard.

Safety of machine tools - Drilling machines

EN 13736:2003+A1:2009 机床的安全性.气动压力机

This European Standard specifies technical safety requirements and protective measures to be adopted by persons undertaking the design as defined in 3.11 of EN 292-1:1991, manufacture and supply of pneumatic presses the intended use of which is the cold working of metal or material partly of metal as defined in 3.3 and hereafter referred as machines. This standard also applies to machines which are integrated into an automatic production line where the hazards and risk arising are comparable to those of machines working separately. This standard also covers pneumatic presses: whose primary intended use is the cold working of metal, which are to be used in the same way to work other sheet materials (e. g. cardboard, plastic, rubber, leather) and metal powder; with an intermediate pneumatic/hydraulic intensifier. The requirements in this standard take account of intended use, as defined in 3.12 of EN 292-1:1991. This standard presumes access to the press from all directions, deals with the hazards described in clause 4, and specifies the safety measures for both the operator and other exposed persons. This standard also applies to ancillary devices which are an integral part of the press. This standard also applies to machines which are integrated into an automatic production line where the hazards and risk arising are comparable to those of machines working separately. This standard does not cover machines whose principal designed purpose is: a) sheet metal cutting by guillotine; b) bending or folding by pneumatic press brakes or folding machines; c) spot welding; d) tube bending; e) straightening; f) drop stamping; g) working by pneumatic hammer; h) compaction of metal powder. Special pneumatic machines for assemblying or calibrating are not covered but this standard may be used as a basis for there machines. This standard does not cover the safety requirements related to the use of PES or PPS. They will be dealt with at its next revision. This standard is not applicable to machines which are manufactured before the date of publication of this document by CEN.

Safety of machine tools - Pneumatic presses