1.3 30 m³ eto gas sterilizer Composition

Eto plinski sterilizator od 30 m³ sastoji se od kućišta sterilizatora, pomoćne opreme (uređaj za grijanje i toplinski ciklus, uređaj za vakuumsku ekstrakciju, uređaj za doziranje i isparavanje, uređaj za ovlaživanje, uređaj za brtvljenje, uređaj za preradu zaostalog plina) te uređaj za nadzor i kontrolu.

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