Sterilizer Quality Assurance

Increasing the effectiveness of the sterilization process (used in autoclave sterilizers or plasma sterilizers) involves a high quality manufacturer autoclave/sterilizer, proper decontamination of loads, regular use of chemical and biological indicators, ongoing sterilizer maintenance, record keeping (documentation), staff training and proper instrument preparation practices. These factors are so crucial for efficient and effective sterilization that they have become standardized.

Quality assurance

Tuttnauer does not only comply with the strictest international standards and directives. As a member of the European Committee for Standardization, we actively develop and define them.
International autoclave standards

EN 285 for Large Autoclaves
EN 13060 for small Autoclaves

ST8 Hospital Sterilizers
ST55 - Small Sterilizers

Directives Guidelines

Medical Device Directive - MDD 93/42
Pressure Equipment Directives - 97/23
2012/19 EU WEE & 2011/65/EU RoHS Directives
FDA Clearance

Safety and EMC standards

EN 61010-2-040
EN 61326-1:2013

Pressure vessel construction standards

ASME Code Section I & Section VII. Div. I
PED 97/23 EC and 2014/68/EU

Good practice standards

ISO 13683
ISO 11134
ST46. ST42

Quality standards

ISO 9001:2015
ISO 13485:2016
21 CFR 820
Canadian MDR (CMDR)
ATG (Medical Devices)
Brazilian Good Manufacturing Practices
Japanese QMS Ordinance