1.3 30 m³ eto gas sterilizer Composition
Eto plynový sterilizátor s objemom 30 m³ sa skladá z krytu sterilizátora, pomocného zariadenia (zariadenie na ohrev a tepelné cyklovanie, zariadenie na vákuovú extrakciu, dávkovacie a odparovacie zariadenie, zvlhčovacie zariadenie, uzatváracie zariadenie, zariadenie na úpravu zvyškového plynu) a monitorovacie a kontrolné zariadenie.
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 | 1 m³ | 16 | 1000 | 380V/50Hz |
| 2 | BCS-2 | 1650*1000*1200 | 2 m³ | 16 | 2000 | 380V/50Hz |
| 3 | BCS-3 | 1400*1350*1700 | 3,0 m³ | 16 | 3000 | 380V/50Hz |
| 4 | BCS-4.5 | 2000*1350*1700 | 4,5 m³ | 27 | 4000 | 380V/50Hz |
| 5 | BCS-5 | 2250*1350*1700 | 5 m³ | 27 | 4500 | 380V/50Hz |
| 6 | BCS-6 | 2700*1350*1700 | 6 m³ | 27 | 5000 | 380V/50Hz |
| 7 | BCS-8 | 3500*1350*1700 | 8 m³ | 27 | 6000 | 380V/50Hz |
| 8 | BCS-10 | 4500*1350*1700 | 10 m³ | 43 | 7000 | 380V/50Hz |
| 9 | BCS-15 | 5500*1350*2000 | 15 m³ | 56 | 9000 | 380V/50Hz |
| 10 | BCS-20 | 7500*1350*2000 | 20 m³ | 81 | 12 000 | 380V/50Hz |
| 11 | BCS-26 | 9600*1350*2000 | 26 m³ | 81 | 14 000 | 380V/50Hz |
| 12 | BCS-28 | 12500*1350*1700 | 28 m³ | 90 | 14 000 | 380V/50Hz |
| 13 | BCS-30 | 11300*1350*2000 | 30 m³ | 90 | 17 000 | 380V/50Hz |
| 14 | BCS-30-2 | 5600*2700*2000 | 30m³-2 | 90 | 16 000 | 380V/50Hz |
| 15 | BCS-35 | 13000*1350*2000 | 35 m³ | 100 | 23 000 | 380V/50Hz |
| 16 | BCS-35-2 | 6000*2700*2200 | 35m³-2 | 100 | 22 000 | 380V/50Hz |
| 17 | BCS-40-2 | 6650*2700*2200 | 40m³-2 | 100 | 23 000 | 380V/50Hz |
| 18 | BCS-48 | 12850*1400*2700 | 48 m³ | 100 | 28 000 | 380V/50Hz |
| 19 | BCS-52 | 13900*1400*2700 | 52 m³ | 150 | 28 000 | 380V/50Hz |
| 20 | BCS-55-2 | 7500*2700*2700 | 55m³-2 | 150 | 27 000 | 380V/50Hz |
| 21 | BCS-57-2 | 9650*2700*2200 | 57m³-2 | 150 | 28 000 | 380V/50Hz |
| 22 | BCS-63-2 | 8650*2700*2700 | 63m³-2 | 150 | 29 000 | 380V/50Hz |
| 23 | BCS-70-2 | 9700*2700*2700 | 70m³-2 | 155 | 32 000 | 380V/50Hz |
| 24 | BCS-78-2 | 10750*2700*2700 | 78m³-2 | 165 | 35 000 | 380V/50Hz |
| 25 | BCS-86-2 | 11800*2700*2700 | 86m³-2 | 165 | 38 000 | 380V/50Hz |
| 26 | BCS-101-2 | 17050*2700*2200 | 101m³-2 | 200 | 45 000 | 380V/50Hz |
| 27 | BCS-120-2 | 20200*2700*2200 | 120m³-2 | 200 | 49 000 | 380V/50Hz |
Sterilizačný cyklus a automatické ovládanie
2.10.7.1
30 m³ eto plynový sterilizátor by mal byť vybavený automatickým ovládačom, ktorý dokáže automaticky riadiť sterilizačný cyklus.
2.10.7.2 Eto plynový sterilizátor triedy A:
- Automatický ovládač by mal byť schopný naprogramovať prednastavené podmienky pre každú fázu sterilizačného cyklu.
- Počas sterilizačného cyklu nesmie meniť prednastavené premenné.
2.10.7.3 Eto plynový sterilizátor triedy B:
- Výrobca používa automatický ovládač na naprogramovanie prednastavených podmienok pre každú fázu sterilizačného cyklu.
- 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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