Quality assurance
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
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)
UL \ EN 61010-1
UL \ EN 61010-2-040
EN 61326-1
ANSI C63.4
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
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
IEC \ EN 62304 Medical Device Software - Software life cycle processes
FDA QSR 21 CFR part 11
2012/19/EU WEEE and EU 2017/2102 Restriction of the use of certain hazardous substances (RoHS Directive)