Our company provides internationally approved and accredited testing, inspection and inspection services to the following standards.
TS EN 556-1 Sterilization of medical devices - Specification for medical devices to be marked as “sterile - - Part 1: Specifications of finally sterilized medical devices
TS EN ISO 17664 Sterilization of medical devices - Information provided by the manufacturer for the processing of re-sterilizable devices
TS EN 556-1 Sterilization of medical devices - Specification for medical devices to be marked "sterile" - Part 1: Specifications for sterile medical devices
TS EN ISO 11137-3 Sterilization of sanitary products - Radiation - Part 3: Guidelines on dosimetric issues
TS EN ISO 18472 Sterilization of health products - Biological and chemical indicators - Test equipment
TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked "sterile" - Part 1: Specifications for sterile medical devices
TS EN ISO 17665-1 Sterilization of healthcare products - Moist heat - Part 1: Specifications for the development, validation and routine control of the sterilization process for medical devices
TS EN 556-1 / AC Sterilization of medical devices - Specification for medical devices to be marked as “sterile - - Part 1: Specifications of finally sterilized medical devices
TS EN ISO 14937 Sterilization of sanitary materials - General requirements for the specification of a sterilizer and the development, validation and routine control of a sterilization process for medical devices
TS EN ISO 14161 Sterilization of health care products - Bionic indicators - Guide for use selection and interpretation of results
TS EN ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Sterilization tests for the validity of a sterilization process
TS EN ISO 17665-1 Sterilization of sanitary products - Humid heat - Part 1 - Requirements for the development, validation and routine control of a sterilization process for medical devices
TSE CEN ISO / TS 17665-2 Sterilization of sanitary products - Damp heat - part 2: Application guide for ISO 17665-1
TS EN ISO 14937 Sterilization of health care products - General rules for the properties of the sterilizing agent and development, validation and routine control of the sterilization process for medical devices
TS EN ISO 25424 Sterilization of medical devices - Low temperature vapor and formaldehyde - Rules for the development, validation and routine control of the sterilization process of medical devices "
TS EN ISO 13408-4 Recommendation Health care products produced under aseptic conditions - Part 4 site cleaning conditions
TS EN ISO 13408-5 Recommendation Health care products produced under aseptic conditions - Part 5 sterilization of floors
TS EN ISO 13408-6 / A1 Recommendation 6-Isolator systems for health care products manufactured under aseptic conditions
TS EN ISO 20857 Sterilization of sanitary materials - Features for the development, verification and routine control of the sterilization process for dry heat-medical devices
TSE ISO / TS 11139 Sterilization of health care products - Terms and definitions
TSE CEN ISO / TS 13004 Sterilization of health care products - Radiation - verification of selected sterilization dose: VDmaxSD Method
TS EN ISO 11135 Sterilization of sanitary materials - Ethylene oxide - Requirements for the development, validation and routine control of the sterilization process of medical devices
TSE ISO / TS 11139 Sterilization of sanitary materials - Terms and definitions
TS EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on the product (ISO 11737-1: 2006)
Sterilization of medical devices - Microbiological methods - Part 11737: Determination of the population of microorganisms on the product (ISO 1-1: 11737 / Correction 1: 2006) TS EN ISO 1-2007 / AC
Sterilization of medical devices - Microbiological methods - Part 11737: Sterility tests for the description, validation and maintenance of a sterilization process (ISO 2-2: 11737)
tst EN ISO 11135 Sterilization of health products - Ethylene oxide - Requirements for the development, validation and routine control of the sterilization process of medical devices (ISO 11135: 2014)
TS EN ISO 11140-1 Sterilization of healthcare equipment - Chemical indicators - Part 1: General properties
TS EN 556-2 Sterilization of medical devices - Specification for medical devices to be marked “STERILE - - Part 2: Characteristics of aseptically processed medical devices
TS EN ISO 13408-1 Health care products manufactured under aseptic conditions - Part 1: General specifications (including ISO 13408-1: 2008, Amd 1: 2013)
TS EN ISO 13408-7 Aseptic health care products - Part 7: Alternative procedures for medical devices and combined products
TS EN ISO 11137-2 Sterilization of sanitary materials - Radiation - Part 2: Determination of sterilization dose
TS EN ISO 11137-1 Sterilization of sanitary materials - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices (including ISO 11137-1: 2006, Amd 1: 2013)
tst 13318Efficient services - Medical waste disposal devices - Rules
TS EN ISO 15882 Sterilization of sanitary materials - Chemical indicators - Guidance for selection, use and evaluation of results (ISO 15882: 2008)
TS ISO / TS 17665-3 Sterilization of health care products - Humid heat - Part 3: Guidance on the inclusion of a medical device in a product family and on the process category of steam sterilization
tst ISO / TS 17665-3 Sterilization of health care products - Humid heat ölSection 3: Guidelines for the inclusion of a medical device in a product family and for the process category of steam sterilization
tst EN ISO 11137-1 Sterilization of sanitary materials - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices (including ISO 11137-1: 2006, Amd 1: 2013)
tst EN ISO 11137-2 Sterilization of sanitary materials - Radiation - Part 2: Determination of sterilization dose
TS EN ISO 11140-3 Sterilization of sanitary products - Chemical indicators - Part 3: Class 2 indicator systems used in the Bowie and dick type vapor permeability test
TS EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on the product
TS EN ISO 11737-1 / AC Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on the product
TS EN ISO 14161 Sterilization of sanitary materials - Biological indicators - Guidance for selection, use and interpretation of results
TS EN ISO 18472 Sterilization of sanitary materials - Biological and chemical indicators - Test equipment