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EVS-EN 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: Replacement:
This part of IEC 60601 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[1]1 and IEC 60601-2-76[2]).
This part of IEC 60601 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[1]1 and IEC 60601-2-76[2]).
Base documents: IEC 60601-2-91:2026; EN IEC 60601-2-91:2026
EVS-EN ISO 80601-2-13:2022/A1:2026
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2022/Amd1:2026)
Scope: Amendment to EN ISO 80601-2-13:2022
Base documents: ISO 80601-2-13:2022/Amd 1:2026; EN ISO 80601-2-13:2022/A1:2026
EVS-EN ISO 22532:2026
Health informatics - Identification of medicinal products - Core vocabulary (ISO 22532:2026)
Scope: This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.
Base documents: ISO 22532:2026; EN ISO 22532:2026
EVS-EN ISO 8980-3:2022/A1:2026
Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods - Amendment 1 (ISO 8980 3:2022/Amd 1:2026)
Scope: Amendment to EN ISO 8980-3:2022
Base documents: ISO 8980-3:2022/Amd 1:2026; EN ISO 8980-3:2022/A1:2026
ISO 24900:2026
Traditional Chinese medicine — Sophora tonkinensis root and rhizome
Scope: This document specifies the minimum requirements and test methods for Sophora tonkinensis root and rhizome.
This document applies to Sophora tonkinensis root and rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document applies to Sophora tonkinensis root and rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Base documents:
ISO 80601-2-13:2022/Amd 1:2026
Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 1
Scope: Amendment to ISO 80601-2-13:2022
Base documents:
Replaced standards
Drafts
EN ISO 15002:2024/prA1
Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)
Scope: Amendment to EN ISO 15002:2024
Base documents: ISO 15002:2023/DAmd 1; EN ISO 15002:2024/prA1
EN ISO 5367:2023/prA1:2026
Anaesthetic and respiratory equipment - Breathing sets and connectors - Amendment 1: Additional requirements for connectors for accessory access connection port (ISO 5367:2023/DAmd1:2026)
Scope: Additional requirements for connectors for accessory access connection port
Base documents: ISO 5367:2023/DAmd 1; EN ISO 5367:2023/prA1:2026
prEN ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137‑2:2026)
Scope: ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Base documents: ISO/DIS 11137-2; prEN ISO 11137-2
prEN ISO 19980
Ophthalmic instruments - Corneal topographers (ISO/DIS 19980:2026)
Scope: This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs.
This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care.
This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye.
NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface.
This document is not applicable to ophthalmic instruments classified as ophthalmometers.
This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care.
This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye.
NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface.
This document is not applicable to ophthalmic instruments classified as ophthalmometers.
Base documents: ISO/DIS 19980; prEN ISO 19980
prEN ISO 9360-2
Heat and moisture exchangers, and breathing system filters for respired gases - Part 2: Measurement of moisture loss (ISO/DIS 9360-2:2026)
Scope: This document specifies requirements for the measurement of moisture loss from heat and moisture exchangers (HMEs), including those incorporating breathing system filters (HMEFs), intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml.
Breathing system filters (BSF) are also included in scope, as these devices do some amount of moisture to inspired gases.
This document also includes requirements for the measurement of moisture loss from HMEs for use with tracheostomized patients that do not have a machine port and having minimum tidal volumes of 250 mL.
Active HMEs are excluded from this document, the requirements for active HMEs are included in ISO 80601-2-74:2026 [1].
NOTE 1 Wherever the term “device” is used in this document, it may either refer to HME, HMEF or BSF.
*** Add rationale why 250ml lower limit***
NOTE 2 HMEs, HMEFs that do not have a machine port for connection to a breathing tube are intended for patients who are spontaneously breathing via a tracheostomy and do not require mechanical ventilation.
Breathing system filters (BSF) are also included in scope, as these devices do some amount of moisture to inspired gases.
This document also includes requirements for the measurement of moisture loss from HMEs for use with tracheostomized patients that do not have a machine port and having minimum tidal volumes of 250 mL.
Active HMEs are excluded from this document, the requirements for active HMEs are included in ISO 80601-2-74:2026 [1].
NOTE 1 Wherever the term “device” is used in this document, it may either refer to HME, HMEF or BSF.
*** Add rationale why 250ml lower limit***
NOTE 2 HMEs, HMEFs that do not have a machine port for connection to a breathing tube are intended for patients who are spontaneously breathing via a tracheostomy and do not require mechanical ventilation.
Base documents: ISO/DIS 9360-2; prEN ISO 9360-2
prEN ISO 9360-1
Heat and moisture exchangers, and breathing system filters for respired gases - Part 1: Common requirements (ISO/DIS 9360-1:2026)
Scope: This document specifies the common requirements for heat and moisture exchangers (HME), breathing
system filters (BSF) and combined devices (HMEF) intended for anaesthetic and respiratory use. It addresses materials, design, performance, requirements for devices supplied sterile, marking, and information to be provided by the manufacturer.
NOTE 1 Wherever the term “device” is used in this document, it refers to an HME or, HMEF or BSF.
This document also applies to HMEs or HMEFs that do not have a machine port for connecting to a ventilator.
Requirements for active HMEs are located in ISO 80601-2-74 [1].
This document is not applicable to other types of filters:
— those designed to protect vacuum sources or gas sample lines;
— to filter compressed gases;
— to protect test equipment for physiological respiratory measurements;
— on inlet of resuscitation bags;
— port of nebulisers.
NOTE 2 A method for assessing moisture loss from an HME/HMEF is given in ISO 9360-2: 202X.
NOTE 3 A method for assessing filtration performance of BSF/HMEF is given in ISO 9360-3:202X.
Filters used for filtering anaesthetic gases from the respiratory gas are not within scope of this document.
NOTE 4 Requirements for Active HMEs are included in ISO 80601-2-74 [1].
system filters (BSF) and combined devices (HMEF) intended for anaesthetic and respiratory use. It addresses materials, design, performance, requirements for devices supplied sterile, marking, and information to be provided by the manufacturer.
NOTE 1 Wherever the term “device” is used in this document, it refers to an HME or, HMEF or BSF.
This document also applies to HMEs or HMEFs that do not have a machine port for connecting to a ventilator.
Requirements for active HMEs are located in ISO 80601-2-74 [1].
This document is not applicable to other types of filters:
— those designed to protect vacuum sources or gas sample lines;
— to filter compressed gases;
— to protect test equipment for physiological respiratory measurements;
— on inlet of resuscitation bags;
— port of nebulisers.
NOTE 2 A method for assessing moisture loss from an HME/HMEF is given in ISO 9360-2: 202X.
NOTE 3 A method for assessing filtration performance of BSF/HMEF is given in ISO 9360-3:202X.
Filters used for filtering anaesthetic gases from the respiratory gas are not within scope of this document.
NOTE 4 Requirements for Active HMEs are included in ISO 80601-2-74 [1].
Base documents: ISO/DIS 9360-1; prEN ISO 9360-1