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Norms & Guidelines

Note: When you click on any of the links, you will leave the Kaye website and thus, our jurisdiction/responsibility. All listed guidelines/standards/ organizations do not claim to be exhaustive. We regularly update this page to stay as current as possible with the constantly changing standards and regulations.

Guidelines & Standards

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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

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