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.
Technical standards

Europe
EN 285 for Large Autoclaves
EN 13060 for small Autoclaves
ISO 14937:2009 Sterilization of healthcare products - For Plazmax H2O2 sterilizer
ISO 17665-1 Sterilization Of Healthcare Products - Moist Heat

USA
ST8 Hospital Sterilizers
ST55 Small Sterilizers
ST79:2017 - Steam Sterilization and Sterility Assurance in Healthcare Facilities

Pressure vessel standards

ASME Code Section I & Section VII. Div. I
PED 97/23 EC and 2014/68/EU
Chinese Regulations- Special Equipment Licensing Office
Canadian Registration Number (CRN)

Electrical safety and EMC standards

UL \ EN 61010-1
UL \ EN 61010-2-040
EN 61326-1
ANSI C63.4

Quality standards

ISO 13485: Quality Management System – Medical devices
Medical Device Single Audit Program- companion document (MDSAP)

  • Australian Therapeutic Goods (Medical Devices) Regulations 2002
  • Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013, 67/2009, 56/2001, 23/2012)
  • Japanese QMS Ordinance (MHLW MO 169)
  • Canadian MDR (CMDR) SOR/98-282 (2018), consolidated
  • FDA QSR 21 CFR part 820 & part 11
Medical Device Directive 93/42/EEC as amended by 2007/47/EC
EN ISO 14971: Medical devices — Application of risk management to medical devices
ISO 9001: Quality Management System
ISO 14001: Environmental management system
ISO 17025: General requirements for the competence of testing and calibration laboratories

 

Software standards

IEC \ EN 62304 Medical Device Software - Software life cycle processes
FDA QSR 21 CFR part 11

Other guidelines

2012/19/EU WEEE and EU 2017/2102 Restriction of the use of certain hazardous substances (RoHS Directive)