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EVS-EN ISO 11137-1:2026
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)
Scope:
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
Base documents: ISO 11137-1:2025; EN ISO 11137-1
EVS-EN ISO 3630-8:2026
Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator (ISO 3630-8:2026)
Scope: This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.
Base documents: ISO 3630-8:2026; EN ISO 3630-8:2026
EVS-EN ISO 3964-1:2026
Dentistry - Coupling dimensions for handpiece connectors - Part 1: Mechanical properties (ISO 3964-1:2026)
Scope: This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s).
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.
Base documents: ISO 3964-1:2026; EN ISO 3964-1:2026
ISO 8980-4:2026
Ophthalmic optics — Uncut finished spectacle lenses — Part 4: Specifications and test methods for the properties of anti-reflective coatings and hydrophobic coatings
Scope: This document specifies optical and non-optical requirements and the test methods for anti-reflective and hydrophobic properties of coatings on spectacle lenses.
This document does not apply to the following topics:
requirements and test methods incorporated in other ISO 8980 series standards;
the colour of the reflected light.
This document does not apply to the following topics:
requirements and test methods incorporated in other ISO 8980 series standards;
the colour of the reflected light.
Base documents:
Replaces: ISO 8980-4:2006
ISO 15194:2026
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
Scope: This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
Base documents:
Replaces: ISO 15194:2009
ISO 15193:2026
In vitro diagnostic medical devices — Requirements for reference measurement procedures
Scope: This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
Base documents:
Replaces: ISO 15193:2009
ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Scope: This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
This document does not apply to MLMD employing large language models (LLM) or generative AI.
Base documents:
ISO 7554-3:2026
Surgical instruments — Terms, measuring methods and test methods — Part 3: Test methods
Scope: This document defines test methods for surgical standard instruments. This document does not cover instruments for use on the central nervous system and on the central cardiovascular system.
Base documents:
ISO TS 24971-2:2026
Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence
Scope:
ISO TS 24971-2:2026 This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
Base documents:
ISO 7554-2:2026
Surgical instruments — Terms, measuring methods and test methods — Part 2: Methods for determination of basic measures
Scope: This document specifies methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system.
NOTE Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy.
NOTE Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy.
Base documents:
IEC 60601-2-91:2026
Medical electrical equipment - Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment
Scope: IEC 60601-2-91:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2 and IEC 60601-2-76).
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2 and IEC 60601-2-76).
Base documents:
Replaced standards
EVS-EN ISO 3964:2016
Dentistry - Coupling dimensions for handpiece connectors (ISO 3964:2016)
Scope: This International Standard describes the coupling between handpieces and motors connected to dental units.
This International Standard specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motors which supply the handpiece with water, air and light and rotation energy.
This International Standard specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motors which supply the handpiece with water, air and light and rotation energy.
Base documents: EN ISO 3964:2016; ISO 3964:2016
Replaced: EVS-EN ISO 3964-1:2026
EVS-EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
Scope: This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
Base documents: EN ISO 11137-1:2015; ISO 11137-1:2006; ISO 11137-1:2006/Amd 1
Replaced: EVS-EN ISO 11137-1:2026
ISO 8980-4:2006
Ophthalmic optics -- Uncut finished spectacle lenses -- Part 4: Specifications and test methods for anti-reflective coatings
Scope: ISO 8980-4:2006 specifies optical and non optical requirements, including durability, and test methods for anti-reflective coatings on spectacle lenses.
ISO 8980-4:2006 does not deal with the following topics:
transmittance and absorbtance;the colour of the reflected light.
ISO 8980-4:2006 does not deal with the following topics:
transmittance and absorbtance;the colour of the reflected light.
Base documents:
Replaced: ISO 8980-4:2026
ISO 15193:2009
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
Scope: ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.
Base documents:
Replaced: ISO 15193:2026
ISO 15194:2009
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation
Scope: ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
Base documents:
Replaced: ISO 15194:2026
EVS-EN ISO 11137-1:2015/A2:2019
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
Scope: Amendment for EN ISO 11137-1:2015
Base documents: ISO 11137-1:2006/Amd 2:2018; EN ISO 11137-1:2015/A2:2019
Replaced: EVS-EN ISO 11137-1:2026
EVS-EN ISO 3964:2016/A1:2019
Dentistry - Coupling dimensions for handpiece connectors - Amendment 1: Interface dimensions (ISO 3964:2016/Amd 1:2018)
Scope: Amendment for EN ISO 3964:2016
Base documents: ISO 3964:2016/Amd 1:2018; EN ISO 3964:2016/A1:2019
Replaced: EVS-EN ISO 3964-1:2026
Drafts
prEN ISO 22882
Castors and wheels - Requirements for swivel castors for hospital beds (ISO/DIS 22882:2026)
Scope: ISO 22882:2016 specifies the technical requirements, the appropriate dimensions and the requirements for the testing of swivel castors for hospital beds with a wheel diameter of 100 mm or more and which have a central locking device. Swivel castors may be used with the main principal dimensions.
Base documents: ISO/DIS 22882; prEN ISO 22882