1.

Product Name
产品名称

(indicating the codes of classifiers)
(表示分类器的代码）

Quantity with unit of measure
有计量单位的数量

Supply of steam steriliser with clean steam generator, performance of FAT/SAT acceptance tests, installation, commissioning, qualification works with provision of IQ/OQ protocols, commissioning of the equipment and briefing of the Consignee's employees.
提供带有清洁蒸汽发生器的蒸汽灭菌器、进行 FAT/SAT 验收测试、安装、试运行、提供 IQ/OQ 协议的鉴定工作、设备试运行以及向收货人的员工介绍情况。

BCZ code UF202100146
BCZ 编码 UF202100146

Classifier Codes:
分类器代码：

OKPD 32.50.12.000 - Sterilizers for surgical or laboratory use
OKPD 32.50.12.000 - 外科或实验室用灭菌器

OKVED 2: 32.50 - Medical instruments and equipment production
OKVED 2: 32.50 - 医疗器械和设备生产

1 pc.
1 件

2.

Place and conditions of equipment delivery
设备交付地点和条件

Delivery of the Equipment shall be made in one batch by the Supplier's forces and means by delivery of the Equipment to the Buyer's (Consignee's) warehouse within 150 (one hundred and fifty) calendar days from the date of prepayment receipt. Early delivery of the Equipment is allowed with the consent of the Buyer.
设备的交付应在收到预付款之日起150（一百五十）个日历日内，通过供应商的力量和方式，将设备一次性交付至买方（收货人）的仓库。经买方同意，允许提前交付设备。

Location of the Buyer's (Consignee's) warehouse: 105 Novorossiyskaya St., Ufa, 450014.
买方（收货人）仓库地址：乌法市 Novorossiyskaya 街 105 号，邮编 450014。

Place of the Works: Branch of NPO Microgen JSC in Ufa ‘Immunopreparat’, located at the address: 105 Novorossiyskaya St., Ufa, 450014, Laboratory and Production Building No. 4.
工作地点NPO Microgen JSC乌法分公司 "Immunopreparat"，地址：乌法市Novorossiyskaya大街105号，450014，4号实验室和生产大楼：地址：乌法市Novorossiyskaya大街105号，邮编：450014，4号实验室和生产大楼。

Shop of antiflu vaccines.
抗流感疫苗商店。

The Supplier, within 15 (fifteen) working days prior to the beginning of FAT testing, shall notify the Buyer in writing about the readiness of the Goods for FAT testing. In the notice the Supplier specifies the time and place of FAT tests. In this case FAT tests shall be conducted not later than 100 (one hundred) calendar days from the date of prepayment receipt.
供应商应在FAT测试开始前15（十五）个工作日内，以书面形式通知买方货物是否准备好进行FAT测试。供应商应在通知中明确 FAT 测试的时间和地点。在这种情况下，FAT 测试应在收到预付款之日起 100（一百）个日历日内进行。

Costs related to the visit of the Purchaser's specialists for FAT tests shall be borne by the Purchaser.
买方专家来访进行 FAT 测试的相关费用应由买方承担。

After the Equipment is handed over to the Buyer, the Supplier undertakes to perform installation, commissioning, SAT acceptance tests, qualification, commissioning, and instruction of the Consignee's employees.
设备移交买方后，供应商承诺进行安装、调试、SAT 验收测试、资格认证、试运行以及对收货人员工的指导。

Within 30 (thirty) calendar days from the date of receipt of the Equipment, the Buyer shall notify the Supplier in writing of its readiness to perform the Works.
自收到设备之日起 30（三十）个日历日内，买方应书面通知供应方其已做好实施工程的准备。

In the notice the Purchaser shall specify the time and place of the Works. The Supplier shall bear the costs associated with the visit of the Supplier's specialists to carry out the Work.
买方应在通知中明确工程的时间和地点。供应商应承担其专家到场实施工程的相关费用。

The Supplier shall report to the Purchaser's (Consignee's) site to carry out the Works no later than ten (10) calendar days after receipt of the Purchaser's notification that the site is ready for the Works.
供应商应在收到买方关于工地已准备就绪的通知后不迟于十（10）个日历日前往买方（收货人）工地实施工程。

Prior to commencement of the Works, the Supplier shall open the packaging and the Buyer shall perform internal acceptance of the Equipment in terms of quantity and completeness.
在工程开始之前，供应商应打开包装，买方应对设备的数量和完整性进行内部验收。

Immediately prior to commencement of the Works, the Purchaser shall hand over the Equipment to the Supplier under an Acceptance Certificate drawn up in accordance with the sample agreed by the Parties. The risk of accidental (loss of) or damage to the Equipment shall be transferred to the Supplier from the moment of signing of the said Acceptance Certificate by the Parties. The Supplier bears the risk of accidental loss (loss) or damage of the Equipment until the moment of signing by the Buyer (Consignee) of the Work Acceptance Certificate. The date of commencement of the Work is the date of signing of the Work Acceptance Certificate.
在工程开工前，买方应立即根据按照双方同意的样本起草的验收证书将设备移交给供应方。自双方签署上述验收证书之时起，设备意外（丢失）或损坏的风险应转移至供应方。在买方（收货人）签署工程验收证书之前，设备意外丢失（遗失）或损坏的风险由供应商承担。工作开始日期为签署工作验收证书的日期。

Term of Work performance - 20 (twenty) calendar days from the date of signing by the Parties of the Acceptance Certificate of Equipment handover to the Supplier for Work performance.
履约期限--自双方签署向供应商移交设备的验收证书之日起 20（二十）个日历日。

Sterilizer is designed for sterilization in stationary conditions by saturated steam under pressure of glassware, equipment, solutions, preparation of technological clothing.
灭菌器设计用于在固定条件下通过压力下的饱和蒸汽对玻璃器皿、设备、溶液和技术服装进行灭菌。

Door opening in the loading zone - right, in the unloading zone - left.
装货区的门开向右，卸货区的门开向左。

Built-in vacuum pump with vacuum value of 95%, not less than 0,08 MPa - availability.
内置真空泵，真空度为 95%，不小于 0.08 兆帕 - 可用性。

Control of sterilization process efficiency is carried out by automatic control system and control of cycle parameters (temperature, pressure, time, date) with recording on a paper carrier (check tape).
灭菌过程效率的控制是通过自动控制系统和循环参数（温度、压力、时间、日期）的控制进行的，并记录在纸载体（检查带）上。

Built-in sterilization programs:
内置消毒程序

Sterilization of textiles and utensils
纺织品和用具的消毒

Sterilization of tools and equipment
工具和设备的消毒

Sterilization of rubber products
橡胶制品消毒

Sterilization of aggressive solutions
侵蚀性溶液的消毒

Program with free parameters
带有自由参数的程序

Steam jacket for quick sterilization and avoiding excessive condensation
蒸汽夹套可快速灭菌并避免过度冷凝

The sterilization cart must be able to withstand a load of up to 250 kg
消毒车必须能承受高达 250 公斤的负载

4

Technical and quality characteristics of the goods
货物的技术和质量特性

Type of sterilizer (two-door) pass-through. Type of door - safe. Number of doors - 2 pcs.
消毒柜类型（双门）通过式。门的类型 - 安全。门的数量 - 2 个。

Both sides of the steriliser shall be equipped with the following instruments as well as indication devices:
灭菌器的两侧应配备以下仪器和指示装置：

a) a device showing the pressure in the sterilisation chamber;
a) 显示消毒室压力的装置；

b) visual indicator ‘Doors closed’;
b) 视觉指示器 "门已关闭"；

c) visual indicator ‘Work in progress’;
c) 视觉指示器 "工作进行中"；

d) visual indicator ‘Cycle completed’;
d) 视觉指示器 "循环已完成"；

e) visual indicator ‘Fault’
e) 视觉指示器 "故障

All control valves on the pipework shall be permanently labelled to indicate their functional purpose in accordance with GOST IEC 61010-2-041.
根据 GOST IEC 61010-2-041 标准，管道上的所有控制阀都必须贴上永久性标签，以标明其功能用途。

Rectangular, horizontally arranged sterilisation chamber (available)
水平布置的矩形灭菌室（可提供）

Height with supports, not more than - 2270 mm.
带支架高度不超过 - 2270 毫米。

Steriliser depth, mm, not more than 2062 mm.
灭菌器深度，毫米，不超过 2062 毫米。

Width of the steriliser, mm, not more than 1792 mm.
消毒柜宽度（毫米），不超过 1792 毫米。

Chamber volume, litres, not less than 2040
箱体容积，升，不小于 2040

Chamber depth, mm, not less than 1700 mm
腔室深度，毫米，不小于 1700 毫米

Chamber width, mm, not less than 1000 mm
腔室宽度，毫米，不小于 1000 毫米

Chamber height, mm, not less than 1200 mm
腔室高度，毫米，不小于 1200 毫米

The steriliser must be operated from three-phase AC mains:
灭菌器必须由三相交流电源供电：

- voltage 380 V ± 10 %
- 电压 380 V ± 10 %

- frequency (50 ± 0.4) Hz
- 频率 (50 ± 0.4) 赫兹

Power consumption, kW, not more than 5
功率消耗，千瓦，不超过 5

Working pressure 0,25 MPa
工作压力 0.25 兆帕

Vacuum not less than 0,08 MPa
真空度不低于 0.08 兆帕

Weight, kg, not more than 2400
重量（千克），不超过 2400

Heating of external surfaces of the equipment during operation not more than 55 °C
运行期间设备外表面的加热温度不超过 55 °C

Cleaning of external surfaces with disinfectant solutions (solutions of hydrogen peroxide, quaternary ammonium compounds, etc.).
用消毒溶液（过氧化氢溶液、季铵化合物溶液等）清洗外表面。

External surfaces of the equipment should be resistant to treatment with disinfectant solutions (solutions of hydrogen peroxide, quaternary ammonium compounds, etc.).
设备的外表面应能耐受消毒溶液（过氧化氢溶液、季铵化合物溶液等）的处理。

The inner surface shall be made of stainless steel 03Х17Н14М3 or equivalent
内表面应由不锈钢 03Х17Н14М3 或同等材料制成

Equivalence parameters: chemical composition, mechanical, physical and technological properties, density, hardness and applicability should meet the requirements of GOST 5632-2014, ‘Interstate standard alloyed stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Marks’.
等效参数：化学成分、机械、物理和技术性能、密度、硬度和适用性应符合 GOST 5632-2014 "国家间标准合金不锈钢和耐腐蚀、耐热和耐热合金 "的要求。标记"。

C

Cr

Fe

Mn

Mo

Ni

P

S

Si

≤0,03

16.8-18.3

basic

1.0-2.0

2.2-2.8

13.5-15.0

≤0.03

≤0.02

≤0.4

Roughness Ra 0.6(8th class)
粗糙度 Ra 0.6（8 级）

Facing and supports shall be made of stainless steel 08Х18Н10 or equivalent.
面层和支架应由 08Х18Н10 不锈钢或同等材料制成。

Parameters of steel equivalence: chemical composition, mechanical, physical and technological properties, density, hardness and applicability shall comply with the requirements of GOST 5632-2014 Stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Grades.’
钢材等效参数：化学成分、机械、物理和技术性能、密度、硬度和适用性应符合 GOST 5632-2014 《不锈钢和合金的耐腐蚀性、耐热性和耐热性》的要求。等级。

Electropolished.
电抛光

Sterilization cart should be made of stainless steel 08Х18Н10 or equivalent -1 pcs.
消毒车应由不锈钢 08Х18Н10 或同等材料制成-1 件。

Parameters of steel equivalence: chemical composition, mechanical, physical and technological properties, density, hardness and applicability should meet the requirements of GOST 5632-2014 “Alloyed stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Grades”
钢材等效参数：化学成分、机械、物理和技术性能、密度、硬度和适用性应符合 GOST 5632-2014 "合金不锈钢和耐腐蚀、耐热和耐热合金 "的要求。等级 "的要求。

The sterilization cart must be able to withstand a load of up to 250 kg
消毒车必须能承受高达 250 公斤的负载

Loading cart shall be made of stainless steel 08Х18Н10 or equivalent - 4 pcs.
装载车应由 08Х18Н10 不锈钢或同等材料制成 - 4 件。

Parameters of steel equivalence: chemical composition, mechanical, physical and technological properties, density, hardness and applicability should meet the requirements of GOST 5632-2014 “Alloyed stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Grades”
钢材等效参数：化学成分、机械、物理和技术性能、密度、硬度和适用性应符合 GOST 5632-2014 "合金不锈钢和耐腐蚀、耐热和耐热合金 "的要求。等级 "的要求。

Sterilization baskets shall be made of stainless steel 08Х18Н10 or equivalent - 8 pcs.
灭菌筐应由不锈钢 08Х18Н10 或同等材料制成 - 8 个。

Parameters of steel equivalence: chemical composition, mechanical, physical and technological properties, density, hardness and applicability should meet the requirements of GOST 5632-2014 “Alloyed stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Grades”
钢材等效参数：化学成分、机械、物理和技术性能、密度、硬度和适用性应符合 GOST 5632-2014 "合金不锈钢和耐腐蚀、耐热和耐热合金 "的要求。等级 "的要求。

Air oil-free compressor - 1 pc.
无油空气压缩机 - 1 台

Receiver volume 50 liters.
接收器容积 50 升。

Capacity, not less than 11 m3/h.
容量不小于 11 立方米/小时。

Power, not less than 1.6 kW.
功率不小于 1.6 千瓦。

Separate door seals - available
单独的门封 - 可提供

Fractional vacuum evacuation of air from the chamber - available.
可从真空室中抽走部分空气。

Compressed air supply interruption protection - available.
可提供压缩空气供应中断保护。

Inability to open the door in the presence of vacuum or pressure in the chamber - present. Blocking of simultaneous opening and opening from the clean side without sterilization - present.
在腔室存在真空或压力的情况下无法打开门 - 存在。在未消毒的情况下，同时打开和从清洁侧打开门受阻 - 存在。

Possibility of diagnostics of units and assemblies in manual mode without connection of additional equipment - availability.
可在不连接额外设备的情况下，以手动模式对设备和组件进行诊断 - 可用性。

Integrated system for automatic installation and removal of the door seal - available.
可提供自动安装和拆卸门封的集成系统。

Steam jacket, which allows a quick access to the sterilization mode and avoids excessive condensation - available.
蒸汽夹套，可快速进入灭菌模式并避免过度冷凝。

Microprocessor control - availability.
微处理器控制 - 可用性。

- availability of a list of error messages in case of malfunction or deviation.
- 在出现故障或偏差时，提供错误信息列表。

- system of access by user with division of access rights.
- 按用户划分访问权限的访问系统。

- emergency stop buttons on both sides.
- 两侧有紧急停止按钮。

- audible alarm.
- 声音警报。

Built-in dot matrix printer (recorder) or built-in thermal printer - availability.
内置点阵打印机（记录仪）或内置热敏打印机 - 可用性。

Russian language display on the loading side - available
加载侧的俄语显示屏 - 可用

Pneumatic control valves - availability.
气动控制阀 - 可用性。

The type of pipe joint connection is Clamp.
管接头的连接方式为卡箍式。

Availability of visual control of pressure in the chamber and jacket by means of pressure gauges on the front panel - availability.
可通过前面板上的压力表对腔室和夹套内的压力进行可视化控制 - 可用性。

Door gasket sealing with compressed air - available.
可用压缩空气密封门垫圈。

Electric door drive - available, with the possibility of manual door opening.
电动门驱动 - 可用，也可手动开门。

Built-in sterilization programs:
内置消毒程序

Sterilization of textiles and utensils - availability.
纺织品和用具的消毒 - 可用性。

Sterilization of tools and equipment - available.
工具和设备消毒 - 可用。

Sterilization of rubber products - available.
橡胶制品灭菌 - 可用。

Sterilization of solutions - available.
溶液灭菌 - 可用。

Program with free parameters - available.
带有自由参数的程序 - 可用。

Test programmes, not less than 2 pcs:
测试程序，不少于 2 个：

‘Bovi-Dick test’ - availability.
博维-迪克试验"--可用性。

‘Test for tightness’ - available.
密封性测试"--可用。

Sterilization dwell time - from 1 to 9999 seconds
灭菌停留时间 - 1 至 9999 秒

Possible sterilization temperature range - from 110⁰С to 134⁰С
可能的消毒温度范围 - 从 110 ⁰ С 到 134 ⁰ С

Validation port - availability
验证端口 - 可用性

Additional sealing flange around the perimeter of the steriliser, isolating the clean and sterile area - available.
灭菌器周边有额外的密封法兰，可隔离清洁区和无菌区。

Door opening hinges according to the project documentation - available.
根据项目文件提供开门铰链。

Built-in vacuum pump - 1pc.
内置真空泵 - 1 个。

Set of spare parts for the 2nd year - availability.
第二年的一套备件 - 可用性。

Thermal insulation material:
隔热材料：

A material that provides thermal insulation any surface of the steriliser that may become hotter than 55°C during normal operation shall be thermally insulated, except where this would impair the function and operation of the steriliser.
隔热材料 消毒柜在正常操作过程中温度可能超过 55°C 的任何表面均应隔热，除非这样做会损害消毒柜的功能和操作。

Processing of welded joints
焊点加工

The following surface defects are not allowed in welded joints:
焊接接头不允许有以下表面缺陷：

- cracks of all types and directions;
- 各种类型和方向的裂缝；

- fistulas;
- 瘘管

- undercuts;
- 暗切；

- heaps, burns and unmelted craters;
- 堆、灼烧和未融化的火山口；

- displacement and joint drift of the edges of the welded elements in excess of the norms stipulated by GOST R 52639-2012
- 焊接元件边缘的位移和连接漂移超过 GOST R 52639-2012 规定的标准

- non-compliance of the shape and dimensions of welds with the requirements of standards, specifications or design;
- 焊缝的形状和尺寸不符合标准、规范或设计要求；

- pores exceeding the norms stipulated by GOST R 52639-2012 (Table 15)
- 孔隙超过 GOST R 52639-2012 规定的标准（表 15）。

- flakiness of the surface and depth of depressions between the seam rolls, exceeding the tolerance for seam reinforcement in height;
- 接缝辊之间的表面剥落和凹陷深度超过接缝加固高度公差；

Internal:
内部

Flush stripping,
齐平剥离、

roughness Ra 0.6 (grade 8) by ultrasonic method according to ND.
粗糙度 Ra 0.6（8 级），采用超声波法，符合 ND 标准。

Exterior:
外观

Ra 0.6 (grade 8) roughness.
Ra 0.6（8 级）粗糙度。

Surface treatment
表面处理

Ricks, nicks, scratches, sinks and other defects are not allowed on the surface elements of the body. If their depth exceeds the minus limit deviations stipulated by the relevant standards and specifications.
车身表面部件不允许有划痕、刻痕、划痕、凹陷和其他缺陷。如果其深度超过相关标准和规范规定的负极限偏差。

Surfaces of parts shall be cleaned from metal splashes resulting from thermal (fire) cutting and welding. Burrs shall be removed and sharp edges of parts and assemblies shall be blunted.
部件表面须清除热（火）切割和焊接产生的金属飞溅物。必须清除毛刺，钝化部件和组件的锋利边缘。

Interior:
内饰

Risks, nicks, scratches, sinks and other defects are not allowed on the inner surface of the chamber if their depth exceeds the minus limit deviations stipulated in the relevant standards and specifications.
如果腔体内表面的风险、缺口、划痕、凹陷和其他缺陷的深度超过相关标准和规格规定的负极限偏差，则不允许出现这些缺陷。

Roughness of surfaces in contact with production waste should correspond to Ra 0.6 (8th class), not lower. Internal surfaces shall be treated by chemical passivation.
与生产废料接触的表面粗糙度应达到 Ra 0.6（8 级），不得低于此值。内表面应进行化学钝化处理。

External surface:
外表面：

Shall be easily cleanable. Roughness Ra 0.6 (grade 8)
应易于清洁。粗糙度 Ra 0.6（8 级）

Control of the central controller with the algorithm of work on the digital media USB-disk, CD-ROM) -1 pc.
通过数字媒体 USB-disk、CD-ROM）-1 pc 上的工作算法控制中央控制器。

Visualisation project of LCD touch screen with read/write algorithm on digital media (USB drive, CD-disk).
在数字媒体（USB 驱动器、光盘）上使用读/写算法的液晶触摸屏可视化项目。

Pure steam generator for the production of saturated water steam used for technological purposes in pharmaceutical production with a maximum capacity of 250±10% kg/hour. With two parallel boilers with a capacity of 0,140 m³.
纯蒸汽发生器用于生产饱和水蒸汽，最大容量为 250±10% 公斤/小时，用于制药行业的技术用途。配有两个容量为 0.140 立方米的并联锅炉。

Steam generator must ensure the quality of pure steam in accordance with the requirements of GOST 31598 2012 (purity, non-condensable gases, dryness, overheating).
蒸汽发生器必须确保纯蒸汽的质量符合 GOST 31598 2012 的要求（纯度、不凝性气体、干燥度、过热）。

Pressurised equipment used in the steam generator for targeted steam supply shall comply with the requirements of GOST 12.2.085 and GOST IEC 61010-2-041.
蒸汽发生器中用于定向供汽的加压设备应符合 GOST 12.2.085 和 GOST IEC 61010-2-041 的要求。

The feed water inlet must be designed to prevent backflow into the feed water supply system.
给水入口的设计必须防止回流到给水供应系统。

Maximum pure steam pressure 0.3 MPa.
最大纯蒸汽压力 0.3 兆帕。

Maximum temperature of pure steam up to 143°C
纯蒸汽最高温度可达 143°C

Nominal voltage 380V, AC three-phase current with frequency 50 Hz, power not more than 1.5 kW
额定电压 380 伏，交流三相电流，频率 50 赫兹，功率不超过 1.5 千瓦

Time of entering the mode not more than 30 min
进入模式的时间不超过 30 分钟

Connected energy carriers:
连接能源载体：

Compressed air pressure 0.4-1MPa.
压缩空气压力 0.4-1MPa。

Pressure of technical water for steam quenching 0.1 MPa.
用于蒸汽淬火的技术用水压力为 0.1 兆帕。

Technical steam pressure 0.5-0.9 MPa, temperature 159-180°C
技术蒸汽压力 0.5-0.9 兆帕，温度 159-180°C

Supply purified water pressure 0.1 MPa, temperature 20°C
供应纯净水压力 0.1 兆帕，温度 20°C

Material of boilers, pipelines and shut-off valves in contact with clean steam - stainless steel 12Х18Н10Т or equivalent.
与清洁蒸汽接触的锅炉、管道和截止阀的材料 - 12Х18Н10Т 不锈钢或同等材料。

Parameters of steel equivalence: chemical composition, mechanical, physical and technological properties, density, hardness and applicability should meet the requirements of GOST 5632-2014 Stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Grades.’
钢材等效参数：化学成分、机械、物理和工艺性能、密度、硬度和适用性应符合 GOST 5632-2014 《不锈钢和合金的耐腐蚀性、耐热性和耐热性》的要求。等级。

Material of facing panels and protective covers - stainless steel 08Х18Н10 or equivalent.
面板和保护罩的材料 - 08Х18Н10 不锈钢或同等材料。

Parameters of steel equivalence: chemical composition, mechanical, physical and technological properties, density, hardness and applicability should meet the requirements of GOST 5632-2014 Stainless steels and alloys corrosion-resistant, heat-resistant and heat-resistant. Grades.’
钢材等效参数：化学成分、机械、物理和工艺性能、密度、硬度和适用性应符合 GOST 5632-2014 《不锈钢和合金的耐腐蚀性、耐热性和耐热性》的要求。等级。

Overall dimensions not more than (DxWxH) 1650x1010x1904 mm.
总尺寸不超过（长x宽x高）1650x1010x1904 毫米。

Combined thermal insulation consisting of certified and hygienically tested thermal insulation materials such as heat-saving ceramic coating ‘TC Ceramic HB’ and foamed rubber material ‘K-Flex’.
组合隔热材料包括经过认证和卫生测试的隔热材料，如隔热陶瓷涂层 "TC Ceramic HB "和发泡橡胶材料 "K-Flex"。

Control panel with indication of all running processes and emergency stop button with lock.
控制面板可显示所有运行进程，并配有带锁的紧急停止按钮。

Presence of safety non-regulated valve with the limit of operation 0,31-0,33 MPa and steam generation capacity of 125 kW. Diameter of the throughput section 15 mm, connection thread ½ inch.
配有安全非调节阀，工作极限为 0.31-0.33 兆帕，蒸汽产生能力为 125 千瓦。通孔直径 15 毫米，连接螺纹 ½ 英寸。

Availability of electro-contact pressure gauges on the panel. Measuring limit from 0 to 4 MPa, pressure gauges with measuring limit from 0 to 4 MPa.
可在面板上安装电接点压力表。测量范围 0 至 4 MPa，压力表测量范围 0 至 4 MPa。

Presence of illuminated water indicators with a nominal pressure of 2.5 MPa. Availability of make-up pump.
标称压力为 2.5 兆帕的照明水指示器。备有补水泵。

Control and monitoring requirements
控制和监测要求

(requirements to have a system for displaying/recording parameters during equipment operation)
(要求在设备运行期间拥有显示/记录参数的系统）。

The system must display and record in the internal memory and on an electronic medium the temperature parameters and the time of the process. With printing via the branch network to the printer.
系统必须在内部存储器和电子媒介上显示并记录温度参数和加工时间。可通过分支网络打印到打印机。

Controlled parameters
受控参数

Energy supply requirements
能源供应要求

5

Product safety requirements
产品安全要求

5.1

The steriliser should be equipped with pressure relief valves
消毒柜应配备泄压阀

5.2

The steriliser must comply with the requirements:
消毒柜必须符合要求：

- Rules of Good Manufacturing Practice (approved by Order of the Ministry of Industry and Trade No. 916 of 14.06.2013).
- 良好生产规范规则》（由工业和贸易部 2013 年 6 月 14 日第 916 号令批准）。

- INTERNATIONAL STANDARD OF THE RUSSIAN FEDERATION ‘Steel welded vessels and apparatus. General specifications. General specifications. GOST R 34347-2017’. ‘Rules of device and safe operation of pressure vessels’.
- 俄罗斯联邦国际标准'钢制焊接容器和设备。一般规格。一般规格。GOST R 34347-2017'。压力容器的装置和安全操作规则》。

The steriliser shall comply with safety requirements according to GOST R 51838-2001
灭菌器应符合 GOST R 51838-2001 的安全要求

5.3

The steriliser must be operated from three-phase AC mains:
灭菌器必须由三相交流电源供电：

Voltage - 380 V ± 10 %; frequency - (50 ± 0.4) Hz.
电压 - 380 V ± 10 %；频率 - (50 ± 0.4) Hz。

5.4

The steriliser must have devices for reliable earthing.
消毒柜必须有可靠的接地装置。

5.5

Control, regulating and setting controls must be securely locked in position to prevent spontaneous or accidental switching on and off.
控制、调节和设置控制器必须牢牢锁定，以防止自发或意外开关。

5.6

Transient resistance between the protective earth clamp and the remote metal part connected to it, not more than 0.1 Ohm
保护接地夹和与其相连的远程金属部件之间的瞬态电阻，不大于 0.1 欧姆

5.7

Insulation resistance between the mains circuit and all metal parts accessible for contact, not less:
电源电路与所有可接触到的金属部件之间的绝缘电阻，不得小于此值：

- under normal conditions - 20 MOhms;
- 正常情况下 - 20 兆欧；

- after moisture resistance test - 2 MOhms;
- 防潮测试后 - 2 兆欧；

- after temperature resistance test - 5 MOhms;
- 温度电阻测试后 - 5 兆欧；

5.8

Electrical insulation class: F or lower.
电气绝缘等级：F 或更低。

5.9

Reports on all tests carried out must be provided.
必须提供所有测试报告。

5.10

The strength calculation of the steriliser and its components shall be performed in accordance with the current normative and technical documentation approved in accordance with the established procedure.
灭菌器及其部件的强度计算应根据现行的规范和技术文件进行，并按照既定程序批准。

5.11

In terms of chemical composition and mechanical properties, materials must meet the requirements of state standards, technical specifications and GOST R 52630-2012
在化学成分和机械性能方面，材料必须符合国家标准、技术规范和 GOST R 52630-2012 的要求

5.12

In the absence of accompanying certificates for materials, their tests should be carried out at the manufacturer of the apparatus in accordance with the requirements of standards or specifications for these materials and the requirements of GOST R 52630-2012. The test results shall be recorded in the product passport.
在没有随附材料证书的情况下，应由设备制造商根据这些材料的标准或规格要求以及 GOST R 52630-2012 的要求进行测试。测试结果应记录在产品手册中。

5.13

Welding materials used in the manufacture of the steriliser must meet the requirements of the relevant standards or TU and have certificates.
消毒柜制造中使用的焊接材料必须符合相关标准或 TU 的要求，并有证书。

5.14

Mechanical tests of weld metal or clad metal should be performed on tensile and impact bending on samples according to GOST 6996-66
应根据 GOST 6996-66 对焊接金属或堆焊金属样品进行拉伸和冲击弯曲机械测试

5.15

Installation of thermal insulation on the steriliser should be carried out after hydraulic and tightness tests.
消毒柜上隔热层的安装应在水压和密封性测试后进行。

5.16

To detect internal defects of welded joints should be used penetrating methods of non-destructive testing: ultrasonic according to GOST R ISO 5577-2009 or radiographic according to GOST 7512-82 in volumes not less than 25% of the length of the controlled weld.
要检测焊接接头的内部缺陷，应采用穿透式无损检测方法：根据 GOST R ISO 5577-2009 标准进行超声波检测，或根据 GOST 7512-82 标准进行射线检测，检测量不小于受控焊缝长度的 25%。

6.

Requirements for dimensions, packaging, shipment of equipment
对设备尺寸、包装和运输的要求

Packaging and marking of the Equipment must comply with the norms valid for this type of Equipment and fully ensure safety of the Equipment and protect it from damage during transportation by all types of transport, taking into account transshipments, overloading, as well as protect the Equipment from atmospheric effects during transportation and storage, according to storage conditions 5 (OZh4) for closed transport and 8 (OZh3) for open transport, GOST 15150-69 “Machines, devices and other technical products. Versions for different climatic regions. Categories, conditions of operation, storage and transportation in terms of exposure to climatic factors of the environment”.
设备的包装和标记必须符合对此类设备有效的规范，并充分确保设备的安全，保护其在各种运输方式的运输过程中不受损坏，同时考虑到转运、超载，以及保护设备在运输和储存过程中不受大气影响，符合封闭运输的储存条件 5 (OZh4) 和开放运输的储存条件 8 (OZh3)，GOST 15150-69 "机器、装置和其他技术产品"。适用于不同气候地区的版本。在暴露于环境气候因素方面的类别、运行条件、储存和运输"。

Each cargo place shall have marking in Russian language containing the name of the Equipment, name of the manufacturer, net and gross weight in kilograms, contract number and number of cargo (tare) place, name of the destination point, name and address of the Consignee, name of the Supplier, manipulation marks indicating the methods of handling the cargo during handling and storage in accordance with international standards.
每个货位都应有俄文标识，包括设备名称、制造商名称、以公斤为单位的净重和毛重、合同号和货位（皮重）号、目的地名称、收货人名称和地址、供应商名称，以及表明货物在装卸和储存期间按照国际标准处理方法的操作标记。

Labeling shall be clear and water resistant.
标签应清晰防水。

Each shipment shall be accompanied by a packing list with the following data:
每批货物均应附有一份装箱单，其中应包括以下数据：

- the number of pieces of Equipment or packages within the cargo space;
- 货舱内设备或包裹的数量；

- the net/gross weight of each load;
- 每件货物的净重/毛重；

- the name of the Equipment.
- 设备名称。

The Supplier shall be liable to the Purchaser for damage to the Equipment due to improper packaging, as well as for corrosion.
供应商应对因包装不当造成的设备损坏及腐蚀向买方承担责任。

7.

Requirements for the period and scope of quality warranty for the equipment
对设备质量保证期限和范围的要求

The warranty period for the Goods is not less than 24 (twenty-four) months from the date of signing by the parties of the Acceptance Certificate.
货物保修期不少于 24（二十四）个月，自双方签署验收证书之日起算。

If during the warranty period any defects, incompleteness of the Equipment are detected, the Supplier shall immediately, or within the period specified by the Buyer, at its own expense, eliminate all detected defects by means of correction or full or partial replacement, based on the Buyer's respective claims.
如果在保修期内发现设备存在任何缺陷或不完整，供应商应立即或在买方指定的期限内，根据买方各自的要求，自费通过纠正或全部或部分更换的方式消除所有发现的缺陷。

The quality of the Goods shall, among other things, be confirmed by test reports, which shall be drawn up based on the results of FAT and SAT acceptances, IQ/OQ qualification works of the Goods.
除其他外，货物的质量应通过测试报告来确认，测试报告应根据货物的 FAT 和 SAT 验收结果、IQ/OQ 质量鉴定工程的结果来编写。

∙FAT and SAT acceptance of the Goods shall be performed according to the protocols agreed and approved in advance.
∙货物的 FAT 和 SAT 验收应根据事先商定和批准的协议进行。

∙FAT acceptance of the Goods shall be performed at the site of the manufacturer's factory. The Supplier shall notify in advance, by letter, of the dates of manufacture and readiness for FAT acceptance prior to shipment of the equipment to the Buyer.
∙货物的FAT验收应在制造商的工厂现场进行。在设备发运给买方之前，供应商应以信函形式提前通知生产日期和FAT验收准备就绪的日期。

∙SAT acceptance is performed after commissioning.
∙SAT 验收在试运行后进行。

∙Initial Installation Qualification (IQ) with a protocol/report.
∙通过协议/报告进行初始安装鉴定 (IQ)。

∙ Initial qualification of operation (OQ) with drawing up a protocol/report.
∙ 通过起草协议/报告进行初始运行鉴定（OQ）。

∙The Parties agree that the proper quality of the Goods shall be considered confirmed only if the protocols of FAT and SAT acceptance, IQ/OQ qualification of the equipment show successful achievement of all declared parameters during their performance.
∙双方同意，只有当设备的 FAT 和 SAT 验收规程、IQ/OQ 鉴定表明在其性能期间成功地达到了所有宣布的参数时，货物的适当质量才应视为得到确认。

8.

  Other requirements to the goods
对货物的其他要求

Requirements to documents included the delivery set
对文件的要求包括交付集

Requirements to the documents included in the delivery set
对成套交付文件的要求

All documents listed below shall be provided in Russian language and shall be submitted in hard copy and electronically.
下列所有文件均应以俄文提供，并应提交打印文本和电子文本。

8.1. consignment note - 3 copies;
8.1. 托运单 - 3 份；

8.2. consignment note in the form of TORG-12 or UPD - 2 copies;
8.2. TORG-12 或 UPD 格式的托运单 - 一式 2 份；

8.3. invoice - 1 copy;
8.3. 发票 - 1 份；

8.4. invoice - 1 copy (not provided if VAT is not levied);
8.4. 发票 - 1 份（如果不征收增值税，则不提供）；

8.5. operating and maintenance manual of the steriliser;
灭菌器的操作和维护手册；

8.6. certificates of conformity for the Equipment, components and materials;
8.6. 设备、部件和材料的合格证书；

8.7. hygienic conclusion;
8.7. 卫生结论；

8.8. technical conclusion;
8.8. 技术结论；

ultrasonic defectoscopy protocols;
超声波缺陷镜检查方案；

8.9. drawing of the steriliser (previously agreed with the Buyer);
8.9. 灭菌器的图纸（事先与买方商定）；

8.10. installation diagram with necessary instructions;
8.10. 带有必要说明的安装图；

8.11. electrical connection diagram of devices and electrical equipment;
8.11. 装置和电气设备的电气连接图；

8.12. Certificate of test of mechanical properties of materials used for manufacturing of the steam steriliser;
8.12.蒸汽灭菌器制造材料的机械性能测试证书；

Certificate of chemical analysis of materials used for manufacturing of the steriliser;
消毒柜制造材料的化学分析证书；

8.13. Certificates of type approval of measuring instruments and registration in the State Register of Measuring Instruments of the Russian Federation for measuring instruments used for control and registration of technological parameters, including the controller. 8.14.
8.13.用于控制和登记技术参数的测量仪器，包括控制器，在俄罗斯联邦国家测量仪器登记册上的测量仪器型式批准证书和登记证书。8.14.

8.14. methods of verification of control and measuring and recording devices registered in the State Register of Measuring Instruments of the Russian Federation, installed on the steam steriliser;
8.14. 蒸汽灭菌器上安装的在俄罗斯联邦国家计量仪器登记册上登记的控制、测量和记录装置的核查方法；

8.15. passports for the steriliser and accessories, including the instrumentation;
8.15. 消毒柜和附件（包括仪器）的护照；

8.16. certificate of verification of measuring instruments. The residual period of verification
8.16. 计量器具检定证书。剩余检定周期

The residual verification period of the measuring instruments shall not be less than 75% of the established verification period at the moment of acceptance of the goods by the Customer.
测量仪器的剩余检定周期不得少于客户验收货物时规定检定周期的 75%。

8.17. factory test reports of the FAT Equipment;
8.17. FAT 设备的出厂测试报告；

as well as other documents stipulated by the Contract and the current legislation of the Russian Federation.
以及合同和俄罗斯联邦现行法律规定的其他文件。

current legislation of the Russian Federation.
俄罗斯联邦现行法律。

8.18. The passport for the steriliser shall be executed in accordance with the requirements of Federal norms and rules in the field of industrial safety ‘Rules of industrial safety when using equipment operating under overpressure’ (approved by the order of Rostechnadzor dated 15.12.2020 N 536).
8.18.灭菌器护照应按照联邦工业安全规范和规则 "使用超压设备时的工业安全规则"（经 Rostechnadzor 2020 年 12 月 15 日第 536 号命令批准）的要求执行。

Upon completion of the Works in full, provided that the result of the Works is satisfactory to the Purchaser, the Supplier shall provide the Purchaser (at the Purchaser's request) with the equipment acceptance certificates after individual testing, equipment acceptance certificates after comprehensive testing.
工程全部竣工后，只要工程结果令买方满意，供应商应（应买方要求）向买方提供单项测试后的设备验收证书和综合测试后的设备验收证书。