30 m2 eto氣體滅菌器

1.3 30 m³ eto gas sterilizer Composition

30 m³ヱ油氣體滅菌器由滅菌器外殼、輔助設備（加熱和熱循環裝置、真空抽吸裝置、加藥和汽化裝置、加濕裝置、密封裝置、殘餘氣體處理裝置）和監測控制裝置組成。

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.	型	Internal Chamber Dimensions (L×W×H) (mm) ±1%	Nominal Volume (m³)	功率（kW）	Weight (kg)	Power Supply
1	BCS-1型	1400 * 700 * 1000	1立方米	16	1000	380V/50Hz
2	BCS-2型	1650 * 1000 * 1200	2立方米	16	2000	380V/50Hz
3	BCS-3型	1400 * 1350 * 1700	3.0立方米	16	3000	380V/50Hz
4	BCS-4.5	2000 * 1350 * 1700	4.5立方米	27	4000	380V/50Hz
5	BCS-5系列	2250 * 1350 * 1700	5立方米	27	4500	380V/50Hz
6	BCS-6系列	2700 * 1350 * 1700	6立方米	27	5000	380V/50Hz
7	BCS-8型	3500 * 1350 * 1700	8立方米	27	6000	380V/50Hz
8	BCS-10型	4500 * 1350 * 1700	10立方米	43	7000	380V/50Hz
9	BCS-15系列	5500 * 1350 * 2000	15立方米	56	9000	380V/50Hz
10	BCS-20系列	7500 * 1350 * 2000	20立方米	81	12000	380V/50Hz
11	BCS-26型	9600 * 1350 * 2000	26立方米	81	14000	380V/50Hz
12	BCS-28型	12500 * 1350 * 1700	28立方米	90	14000	380V/50Hz
13	BCS-30型	11300 * 1350 * 2000	30立方米	90	17000	380V/50Hz
14	BCS-30-2型	5600 * 2700 * 2000	30立方米-2	90	16000	380V/50Hz
15	BCS-35型	13000 * 1350 * 2000	35立方米	100	23000	380V/50Hz
16	BCS-35-2型	6000 * 2700 * 2200	35立方米-2	100	22000	380V/50Hz
17	BCS-40-2型	6650 * 2700 * 2200	40立方米-2	100	23000	380V/50Hz
18	BCS-48型	12850 * 1400 * 2700	48立方米	100	28000	380V/50Hz
19	BCS-52型	13900 * 1400 * 2700	52立方米	150	28000	380V/50Hz
20	BCS-55-2型	7500 * 2700 * 2700	55立方米-2	150	27000	380V/50Hz
21	BCS-57-2	9650 * 2700 * 2200	57立方米-2	150	28000	380V/50Hz
22	BCS-63-2	8650 * 2700 * 2700	63立方米-2	150	29000	380V/50Hz
23	BCS-70-2型	9700 * 2700 * 2700	70立方米 -2	155	32000	380V/50Hz
24	BCS-78-2	10750 * 2700 * 2700	78立方米-2	165	35000	380V/50Hz
25	BCS-86-2型	11800 * 2700 * 2700	86立方米-2	165	38000	380V/50Hz
26	BCS-101-2	17050 * 2700 * 2200	101立方米-2	200	45000	380V/50Hz
27	BCS-120-2型	20200 * 2700 * 2200	120m³-2	200	49000	380V/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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