1.3 30 m³ eto gas sterilizer Composition

м3 это газ стерилизатор стерилизатор корпус гыч, полыш оборудований гыч шога (шокшо да шокшо цикл ӱзгар, вакуумный лукмо ӱзгар, дозироватлымаш да испарительный ӱзгар, вӱдыжгӧ ӱзгар, герметизаций ӱзгар, кодшо газым обрабатыватлыше ӱзгар), мониторинг да управлений ӱзгар.

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.ModelInternal Chamber Dimensions (L×W×H) (mm) ±1%Nominal Volume (m³)
Power (kW)Weight (kg)Power Supply
1BCS-11400*700*10001м3161000380V/50Hz
2BCS-21650*1000*12002м3162000380V/50Hz
3BCS-31400*1350*17003.0м3163000380V/50Hz
4BCS-4.52000*1350*17004.5м3274000380V/50Hz
5BCS-52250*1350*17005м3274500380V/50Hz
6BCS-62700*1350*17006м3275000380V/50Hz
7BCS-83500*1350*17008м3276000380V/50Hz
8BCS-104500*1350*170010м3437000380V/50Hz
9BCS-155500*1350*200015м3569000380V/50Hz
10BCS-207500*1350*200020м38112000380V/50Hz
11BCS-269600*1350*200026м38114000380V/50Hz
12BCS-2812500*1350*170028м39014000380V/50Hz
13BCS-3011300*1350*200030м39017000380V/50Hz
14BCS-30-25600*2700*200030м3-29016000380V/50Hz
15BCS-3513000*1350*200035м310023000380V/50Hz
16BCS-35-26000*2700*220035м3-210022000380V/50Hz
17BCS-40-26650*2700*220040м3-210023000380V/50Hz
18BCS-4812850*1400*270048м310028000380V/50Hz
19BCS-5213900*1400*270052м315028000380V/50Hz
20BCS-55-27500*2700*270055м3-215027000380V/50Hz
21BCS-57-29650*2700*220057м3-215028000380V/50Hz
22BCS-63-28650*2700*270063м3-215029000380V/50Hz
23BCS-70-29700*2700*270070м3-215532000380V/50Hz
24BCS-78-210750*2700*270078м3-216535000380V/50Hz
25BCS-86-211800*2700*270086м3-216538000380V/50Hz
26BCS-101-217050*2700*2200101м3-220045000380V/50Hz
27BCS-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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