| Standard/ Guideline |
Name |
| Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities |
AAMI ST79 |
| Sterilization of health care productsRadiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits |
AAMI TIR35:2016/(R)2021 |
| Sterilization of health care products - Radiation - Guidance on sterilization of human tissue-based products |
AAMI TIR37: 2013 |
| Sterilization of health care products-Radiation |
AAMI TIR40:2018 |
| Guidelines on the Calibration of Temperature and/or Humidity Controlled Enclosures |
AFNOR NF X 15-140 |
| Dry heat (heated air) sterilizers |
ANSI/AAMI ST50:2004/(R)2018 |
| Table-top steam sterilizers |
ANSI/AAMI ST55:2016/(R)2023 |
| Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
ANSI/AAMI ST79 |
| Hospital steam sterilizers |
ANSI/AAMI ST8:2013/(R)2018 |
| Sterilization of health care products - Radiation |
ANSI/AAMI/ISO 11137-03: 2017 |
| Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
ANSI/AAMI/ISO 11138-5:2017/(R)2024 |
| Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD |
ANSI/AAMI/ISO 13004:2022 |
| Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
ANSI/AAMI/ISO 14937:2009/(R)2013 |
| Sterilization of health care products -Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices |
ANSI/AAMI/ISO 11135:2014 |
| Sterilization of health care products - Moist Heat |
ANSI/AAMI/ISO TIR17665-2:2009/(R)2016 |
| Sterilization of health care products - Chemical indicators |
CAN/CSA-ISO 11140-3 |
| Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
CSA ISO 11139 |
| Sterilization of health care products - Microbiological methods |
CSA ISO 11737-1 |
| Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010, IDT) |
CSA ISO 20857 |
| Sterilization of health care products - Moist heat |
CSA Z17665-1 |
| Electrical laboratory devices - Heating ovens and incubators |
DIN 12880 |
| Requirements for the validation of cleaning and disinfection processes |
DIN 58341 |
| Sterilization of health care products - Radiation - Confirmation of selected sterilization dose: Method |
DIN CEN ISO/TS 13004 |
| Biotechnology - Performance criteria for steam sterilizers and autoclaves |
DIN EN 12347 |
| Temperature recorders for the transport, storage and distribution of temperature |
DIN EN 12830 |
| Sterilization - Steam sterilizers - Large sterilizers |
DIN EN 13060 |
| Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
DIN EN 14180 |
| Controlled environment storage cabinet for processed thermolabile endoscopes |
DIN EN 16442 |
| Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing |
DIN EN 17180 |
| Sterilization - Steam sterilizers - Large sterilizers |
DIN EN 285 |
| Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization |
DIN EN 550 |
| Sterilization of medical devices - Validation and routine control of sterilization by moist heat |
DIN EN 554 (replaced by DIN ISO 17665) |
| Sterilization of medical devices |
DIN EN 556 |
| Environmental testing |
DIN EN 60068 |
| Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers |
DIN EN 867-5 |
| General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
DIN EN ISO 14937 |
| Sterilization of health-care products - Ethylene oxide; Requirements for the development, validation and routine control of a sterilization process for medical devices |
DIN EN ISO 11135 |
| Sterilization of health care products - Biological indicators |
DIN EN ISO 11138 |
| Sterilization of health care products - Chemical indicators |
DIN EN ISO 11140 |
| Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
DIN EN ISO 15882 |
| Washer-disinfector; Performance requirements and test method criteria for demonstrating cleaning efficacy. |
DIN EN ISO 15883 |
| Sterilization of health care products - Biological and chemical indicators - Test equipment |
DIN EN ISO 18472 |
| Specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices |
DIN EN ISO 20857 |
| Sterilizers for medical purposes - Small steam sterilizers |
DIN EN ISO 13060 |
| Calibration of Climatic Chambers |
DKD-R 5-7 |
| Manufacture of Sterile Medicinal Products |
EU GMP Annex 01 |
| Manufacture of Biological Medicinal Products for Human Use |
EU GMP Annex 02 |
| Manufacture of Radiopharmaceuticals |
EU GMP Annex 03 |
| Computerised Systems |
EU GMP Annex 11 |
| Qualification and Validation |
EU GMP Annex 15 |
| Pharmaceutical Quality System |
EU GMP Chapter 1 |
| Premises and Equipment |
EU GMP Chapter 3 |
| Production |
EU GMP Chapter 5 |
| Quality Control |
EU GMP Chapter 6 |
| Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs |
FDA 21 CFR part 210 |
| Current Good Manufacturing Practice for Finished Pharmaceuticals |
FDA 21 CFR part 211 |
| Regulations on electronic records and electronic signatures |
FDA 21 CFR part11 |
| FDA Guide to Inspections of Lyophilization of Parenteral |
FDA Inspection Guide |
| FDA Guide to Inspections of Sterile Drug Substance Manufacturers |
FDA Inspection Guide |
| FDA Guide to Inspections of Pharmaceutical Quality Control Labs |
FDA Inspection Guide |
| FDA Guide to Inspections of Foreign Medical Device Manufacturers |
FDA Inspection Guide |
| FDA Guide to Inspections of Foreign Pharmaceutical Manufacturers |
FDA Inspection Guide |
| FDA Inspection Technical Guide Water for Pharmaceutical Use |
FDA Inspection Guide |
| FDA Instection Technical Guide Expiration Dating and Stability Testing for Human Drug Products |
FDA Inspection Guide |
| Validation and periodic testing of the various sterilization processes used in hospitals, laboratories and other healthcare facilities |
HTM 2010 |
| Stability testing of active pharmaceutical ingredients and finished pharmaceutical products |
ICH Guideline - Annex10 |
| Targeted Revisions of the ICH Stability Guideline Series |
ICH Guideline - Q1/Q5C EWG |
| Pharmaceutical Quality System |
ICH Guideline - Q10 |
| Stability testing of Biotechnological / Biological products |
ICH Guideline - Q1A |
| Stability testing of New Drug Substances and Products |
ICH Guideline - Q5C |
| Quality Risk Management |
ICH Guideline - Q9 |
| Stability Testing of new drug substances and products |
ICH Q1A (R2) |
| Environmental testing |
IEC 60068 |
| Thermocouples |
IEC 60584-1 |
| Industrial Platinum Resistance Thermometers |
IEC 60751 |
| ILAC Guidelines for Measurement Uncertainty in Testing |
ILAC G17 |
| Measurement management systems — Requirements for measurement processes and measuring equipmen |
ISO 10012 |
| Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization |
ISO 11134 |
| Sterilization of health care products - Radiation |
ISO 11137 |
| Sterilization of health care products - General requirements for characterization of a sterilizing agent and for the development, validation and routine control of a sterilization process |
ISO 14937 |
| Sterilization of health care products - Moist heat |
ISO 17665 |
| Testing and calibration laboratories |
ISO/IEC 17025 |
| Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO/WD 22441 |
| Controlled Temperature Chamber Mapping and Monitoring |
ISPE Good Practice Guide |
| Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control |
PDA Technical Report No. 01 |
| Validation of Dry Heat Processes Used for Depyrogenation and Sterilization |
PDA Technical Report No. 03 |
| Design Concepts For the Validation of a Water for Injection System |
PDA Technical Report No. 04 |
| Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat |
PDA Technical Report No. 30 |
| Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products |
PDA Technical Report No. 34 |
| Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification |
PDA Technical Report No. 48 |
| Implementation of Quality Risk Management For Pharmaceutical and Biotechnology Manufacturing Operations |
PDA Technical Report No. 54 |
| Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid/ Dosage Forms |
PDA Technical Report No. 60 |
| Data Integrity Management System for Pharmaceutical Laboratorie |
PDA Technical Report No. 80 |
| Guide to Good Manufacturing Practice for Medicinal Products |
PIC/S (PE 009-17) |
| Chapters on Good Storage and Distribution Practices |
USP (1079) Series |
| Monitoring Devices—Time, Temperature, and Humidity |
USP〈1118〉 |
| WHO Guidelines on quality and risk management |
WHO Guidelines |
Validación Térmica & Monitoreo ambiental">
