1.3 30 m³ eto gas sterilizer Composition

30 m³ eto ग्यास स्टेरिलाइजरले स्टेरिलाइजर हाउसिंग, सहायक उपकरण (तातो र थर्मल साइकल चलाउने उपकरण, भ्याकुम निकासी उपकरण, खुराक र वाष्पीकरण उपकरण, आर्द्रीकरण उपकरण, सील उपकरण, अवशिष्ट ग्यास प्रशोधन उपकरण), र निगरानी र नियन्त्रण उपकरण समावेश गर्दछ।

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.मोडेलInternal Chamber Dimensions (L×W×H) (mm) ±1%Nominal Volume (m³)
पावर (kW)Weight (kg)Power Supply
BCS-11400*700*10001m³१६1000380V/50Hz
BCS-21650*1000*12002m³१६2000380V/50Hz
BCS-31400*1350*17003.0m³१६3000380V/50Hz
BCS-4.52000*1350*17004.5m³२७4000380V/50Hz
BCS-52250*1350*17005m³२७4500380V/50Hz
BCS-62700*1350*17006m³२७5000380V/50Hz
7BCS-83500*1350*17008m³२७6000380V/50Hz
8BCS-104500*1350*170010m³४३7000380V/50Hz
9BCS-155500*1350*200015m³५६9000380V/50Hz
१०BCS-207500*1350*200020m³८१12000380V/50Hz
11BCS-269600*1350*200026m³८१14000380V/50Hz
१२BCS-2812500*1350*170028m³९०14000380V/50Hz
13BCS-3011300*1350*200030m³९०17000380V/50Hz
14BCS-30-25600*2700*200030m³-2९०16000380V/50Hz
१५BCS-3513000*1350*200035m³१००23000380V/50Hz
१६BCS-35-26000*2700*220035m³-2१००22000380V/50Hz
17BCS-40-26650*2700*220040m³-2१००23000380V/50Hz
१८BCS-4812850*1400*270048m³१००28000380V/50Hz
19BCS-5213900*1400*270052m³१५०28000380V/50Hz
२०BCS-55-27500*2700*270055m³-2१५०27000380V/50Hz
21BCS-57-29650*2700*220057m³-2१५०28000380V/50Hz
22BCS-63-28650*2700*270063m³-2१५०29000380V/50Hz
23BCS-70-29700*2700*270070m³-2१५५32000380V/50Hz
२४BCS-78-210750*2700*270078m³-2१६५35000380V/50Hz
25BCS-86-211800*2700*270086m³-2१६५38000380V/50Hz
26BCS-101-217050*2700*2200101m³-2२००45000380V/50Hz
२७BCS-120-220200*2700*2200120m³-2२००49000380V/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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