The Classic Prestige autoclave sterilizer has been designed to comply in part or full with the following standards:

FDA - 510K # K962903
Both of these units 210006 & 210007 have the FDA 510K clearance & approval.

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For the approval listed on the FDA web site, click here FDA

UL 544 - (USA) Underwriters Laboratory covering electrical and product safety.

CSA Class 8721 01 - (Canada) Canadian Standards Association covering electrical and product safety.

To all our Canadian customers:

The 210006 is approved for use in Canada and carries a CSA mark as well as a TSSA for the pressure vessel.

Please provide this information to any local inspectors who may be asking.

The CSA Certificate is attached.

The TSSA approval refers to the TSSA reference BPV-D-07-0642 and states that our pressure vessel design has been registered under CRN:OH12089.5, dated 26 Feb 2008

ESCHLE - (UK) Electrical Safety Code for Hospital Laboratory Equipment.

BS 3970 Part 4 - British Standard for autoclaves. Pressure vessel complies.

IEC 601 - Electrical and product safety standard.

DIN 58946 - Part 8. Type testing for microbiological performance.

Prestige Classic 210006

Prestige Classic 210007

• Extended life green gasket.
  
  
• Mechanical interlock system prevents lid from being removed while pressure remains in the chamber.
  
  
• Gasket offset device prevents pressure build up if lid is not correctly fitted.
  
  
• At only 9.9 pounds net weight with chamber size of approximately 8" x  9", the 2100 is ideal for most sterilization applications.
  
  
• For the assurance of quality each autoclave is computer tested and issued with a test certificate showing the temperature time cycle.
  
  
• Application Specific Integrated Circuit (ASIC) is used to improve performance and reliability.
  
  
• Simple 1-step operation starts the fully automatic cycle.
  
  
• Light sequence indicators show "power to the unit"-"cycle in progress"-"sterilization cycle complete".
  
  
• Electronic detectors turn off power if there is insufficient water charge.