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Floor-Standing Autoclave Sterilizer Machine Following cGMP Regulations
Technical Standard :
- GB150.1~GB150.4-2011 Steel Pressure Vessel
- GB/T 191-2008 Pictorial Markings for Handling of Packages
- GB4793.1-2007 Measurement, Control and Lab Safety Requirements of Electrical Equipment,
- Part 1: General Requirement
- GB9969.1-1998 General Principles for Preparation of Instructions for Use of Industrial Products
- GB/T14710-2009 The Environmental Requirements and Test Methods for
- Medical Electrical Equipment
- GB18278-2000 Sterilization of Health Care Products--Requirements for Validation and Routine Control--Industrial Moist Heat Sterilization
- JB/T4711-2003 Coating, Shipping and Packing of Pressure Vessel
- YY0076-1992 metal Parts Classification Technology Conditions of Coating
- YY0085.1-1992 Pulse Vacuum Pressure Steam Sterilizer
- SFDA 2010 version GMP
- Chinese Pharmacopoeia 2010
- Supervision Regulation on Safety Technology for Fixed Type Pressure Vessel
- ISPE, Volume 4, Water and Steam System, Edition 1, Jan.2001
Quality Standards:
- cGMP
- ISO 9001:2008 - Quality Management Systems
- ISO 13485:2012 Quality Management System – Medical Devices
Specification:
| Model | MDB-1.0 | |
| Door numberFloor - Standing Medical Autoclave Sterilizer Machine , Sterilizing Hospital Equipment |
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