1.3 30 m³ eto gas sterilizer Composition

Газовый стерилизатор это объемом 30 м³ состоит из корпуса стерилизатора, вспомогательного оборудования (устройства нагрева и термоциклирования, устройства вакуумной экстракции, устройства дозирования и испарения, устройства увлажнения, устройства герметизации, устройства обработки остаточного газа) и устройства контроля и управления.

1.4 Classification

Based on the size of the eto gas sterilizer, there are two types: Class A and Class B.

  • Class A eto gas sterilizer — User-programmable sterilizer with a sterilization chamber volume > 1 m³, suitable for sterilizing in the medical device manufacturing industry.
  • Class Beto gas sterilizer — A sterilizer with one or more preset sterilization cycles and size limitations, with a sterilization chamber volume ? 1 m³, suitable for sterilizing clinical medical devices.

1.5 Model Difference Table

Table 1: Models and Basic Parameters of Ethylene Oxide Sterilizers

Serial No.МодельInternal Chamber Dimensions (L×W×H) (mm) ±1%Nominal Volume (m³)
Мощность (кВт)Weight (kg)Power Supply
1БКС-11400*700*10001m³161000380V/50Hz
2БКС-21650*1000*12002m³162000380V/50Hz
3БКС-31400*1350*17003,0 м³163000380V/50Hz
4БКС-4,52000*1350*17004,5 м³274000380V/50Hz
5БКС-52250*1350*17005m³274500380V/50Hz
6БКС-62700*1350*17006m³275000380V/50Hz
7БКС-83500*1350*17008m³276000380V/50Hz
8БКС-104500*1350*170010m³437000380V/50Hz
9БКС-155500*1350*200015m³569000380V/50Hz
10БКС-207500*1350*200020 м³8112000380V/50Hz
11БКС-269600*1350*200026 м³8114000380V/50Hz
12БКС-2812500*1350*170028 м³9014000380V/50Hz
13БКС-3011300*1350*200030 м³9017000380V/50Hz
14БКС-30-25600*2700*200030 м³-29016000380V/50Hz
15БКС-3513000*1350*200035 м³10023000380V/50Hz
16БКС-35-26000*2700*220035 м³-210022000380V/50Hz
17БКС-40-26650*2700*220040 м³-210023000380V/50Hz
18БКС-4812850*1400*270048 мграни10028000380V/50Hz
19БКС-5213900*1400*270052 мграни15028000380V/50Hz
20БКС-55-27500*2700*270055 м³-215027000380V/50Hz
21БКС-57-29650*2700*220057 м³-215028000380V/50Hz
22БКС-63-28650*2700*270063 м³-215029000380V/50Hz
23БКС-70-29700*2700*270070 м³-215532000380V/50Hz
24БКС-78-210750*2700*270078 м³-216535000380V/50Hz
25БКС-86-211800*2700*270086 м³-216538000380V/50Hz
26БКС-101-217050*2700*2200101 м³-220045000380V/50Hz
27БКС-120-220200*2700*2200120m³-220049000380V/50Hz

Sterilization Cycle and Automatic Control

2.10.7.1

The 30 m³ eto gas sterilizer should be equipped with an automatic controller that can automatically control the sterilization cycle.

2.10.7.2 Class A eto gas sterilizer:

  • The automatic controller should be able to program preset conditions for each stage of the sterilization cycle.
  • During the sterilization cycle, it must not change the preset variables.

2.10.7.3 Class B eto gas sterilizer:

  • The manufacturer applies the automatic controller to program the preset conditions for each stage of the sterilization cycle.
  • The manufacturer should provide methods to shorten the sterilization time for verification purposes, which can only be performed using a special key, password, or tool. Once the sterilization time is shortened, there should be a fault indication at the end of the operating cycle.

2.10.7.4

The controller should only be accessible using a special key, password, or tool. Additionally: a) For Class A sterilizers, access to the controller and setting of operational cycle variables should require a special key, password, or tool.
b) For Class B sterilizers, only the manufacturer can program new operational cycles.

2.10.7.5

During maintenance, testing, or emergencies, the program of the automatic controller should be operable manually. The manual device used should differ from the special key, password, or tool specified in section 2.10.7.4. When manual operation is performed due to maintenance, testing, or emergencies, the automatic program should stop automatically. The manual operation system should not pose a safety threat, allowing only one stage to be selected sequentially at a time.

2.10.7.6

Upon successful completion of each specified sterilization cycle, the automatic controller should indicate that the cycle is complete.

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