Infoteenus
11 TERVISEHOOLDUS
Uued standardid
ISO 6335-1:2026
Surgical instruments — Staplers — Part 1: Vocabulary
Käsitlusala:
This document defines terms related to staplers and their components.
This document only applies to instruments that use staples.
NOTE Commonly used forms of staples can be found in Figure 1.
This document only applies to instruments that use staples.
NOTE Commonly used forms of staples can be found in Figure 1.
Alusdokumendid:
EVS-EN IEC 60601-2-64:2026
Elektrilised meditsiiniseadmed. Osa 2-64: Erinõuded kergete ioonide kimbuga kiiritusraviseadmete esmasele ohutusele ja olulistele toimimisnäitajatele
Käsitlusala:
IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of patients. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
Alusdokumendid:
IEC 60601-2-64:2025; EN IEC 60601-2-64:2026
Asendab:
EVS-EN 60601-2-64:2015
EVS-EN IEC 80601-2-89:2026
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children
Käsitlusala:
IEC 80601-2-89:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm. If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply. This document does not apply to: • ADULT only beds covered by IEC 80601-2-52; • SPECIALITY MATTRESS covered by the ISO 20342 series; • incubators covered by IEC 60601-2-19; • devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table). If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
Alusdokumendid:
IEC 80601-2-89:2025; EN IEC 80601-2-89:2026
Asendab:
EVS-EN 50637:2017
CEN/CLC/ETSI/TR 101551:2026
Guidelines for public procurement of ICT products and services in the European Union: accessibility award criteria and conformity assessment
Käsitlusala:
This Technical Report (TR) provides guidance to contracting authorities on how to determine contract award criteria to meet the accessibility requirements of Directive (EU) 2019/882 (European Accessibility Act, EAA) and Directive (EU) 2016/2102 (Web Accessibility Directive, WAD); and on how to verify the conformance of publicly procured ICT products and services with these requirements. The present document describes how the accessibility requirements for the procured ICT should be specified, documented and assessed in the frame of the procurement process, under the EU Public Procurement Directives1. The different mechanisms for conformity assessment with the applicable accessibility requirements are explained. It is discussed how these mechanisms may be applied both in the pre-procurement research phase and when awarding a contract, as well as part of contract management in the post-award stage. This Technical Report also provides a useful guidance for bidders who prepare an offer for public procurement of ICT products and services, and others aiming to procure accessible ICT.
Alusdokumendid:
CEN/CLC/ETSI/TR 101551:2026
ISO/TS 5137:2026
Medical device maintenance management programme for healthcare delivery organizations (HDO)
Käsitlusala:
This document specifies requirements for the maintenance management programme of reusable medical devices that require maintenance under the supervision of healthcare delivery organizations (HDOs). This document neither provides guidance nor is applicable to modification of medical device. This document does not apply to manufacturers that install, test, maintain, and service their own medical device.
This document focuses on HDOs and biomedical engineering services (BES) responsibilities.
This document focuses on HDOs and biomedical engineering services (BES) responsibilities.
Alusdokumendid:
ISO 21370:2026
Traditional Chinese medicine — Dendrobium officinale stem
Käsitlusala:
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo.
It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Alusdokumendid:
Asendab:
ISO 21370:2019
ISO 6335-2:2026
Surgical instruments — Staplers — Part 2: General requirements
Käsitlusala:
This document specifies general requirements for staplers, including requirements for stapler classification, intended performance, design attributes, design evaluation, manufacturing, sterilization, packaging, information supplied by the manufacturer, and tests to demonstrate conformance with these requirements.
This document is applicable to single-use staplers and reusable staplers.
This document only applies to instruments that use staples.
This document is applicable to single-use staplers and reusable staplers.
This document only applies to instruments that use staples.
Alusdokumendid:
ISO 20342-4:2026
Assistive products for tissue integrity when lying down — Part 4: Test methods for durability
Käsitlusala:
This document specifies conditions and test methods for the durability of assistive products for tissue integrity (APTI) when lying down. These methods are additional to the ones in ISO 20342-1.
This document is applicable to both reactive and active APTIs, such as mattresses and overlays, and includes single-patient multiple-use products.
This document does not apply to single-use products.
NOTE This document is intended to help differentiate the durability characteristics between APTIs. It is not intended for determining overall performance or for ranking or scoring of such APTIs.
This document is applicable to both reactive and active APTIs, such as mattresses and overlays, and includes single-patient multiple-use products.
This document does not apply to single-use products.
NOTE This document is intended to help differentiate the durability characteristics between APTIs. It is not intended for determining overall performance or for ranking or scoring of such APTIs.
Alusdokumendid:
EVS-EN IEC 62083:2026
Meditsiiniseadme tarkvara. Nõuded kiiritusravi planeerimissüsteemide ohutusele
Käsitlusala:
This Standard, with the inclusion of type test (3.2.70) and site test (3.2.58), applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system (RTPS) (3.1.14) as well as communication of the radiotherapy treatment planning system (RTPS) (3.1.14) with other devices:
- used in medical practice;
- that imports data either through input by the operator (3.2.39) or from other devices;
- that outputs data to other devices; and
- that is intended to be
- for normal use (3.2.36) , under the authority of appropriately qualified person (3.1.12), by operator (3.2.39) having the required skills and training;
- used and maintained in accordance with the recommendations given in the instructions for use (3.2.23) , and
- used within the environmental conditions specified (3.2.61) in the technical description.
This standard applies to any software application that is used for the development, evaluation, or approval of a treatment plan (3.1.18) , whether stand-alone or part of another system.
Such software applications include prescribing systems, contouring systems, quality assurance (3.2.45) systems, plan analysis systems, or plan review systems.
- used in medical practice;
- that imports data either through input by the operator (3.2.39) or from other devices;
- that outputs data to other devices; and
- that is intended to be
- for normal use (3.2.36) , under the authority of appropriately qualified person (3.1.12), by operator (3.2.39) having the required skills and training;
- used and maintained in accordance with the recommendations given in the instructions for use (3.2.23) , and
- used within the environmental conditions specified (3.2.61) in the technical description.
This standard applies to any software application that is used for the development, evaluation, or approval of a treatment plan (3.1.18) , whether stand-alone or part of another system.
Such software applications include prescribing systems, contouring systems, quality assurance (3.2.45) systems, plan analysis systems, or plan review systems.
Alusdokumendid:
EN IEC 62083:2026; IEC 62083:2025
Asendab:
EVS-EN 62083:2010
EVS-EN IEC 61267:2026
Medical diagnostic x-ray equipment - Radiation conditions for use in the determination of characteristics
Käsitlusala:
This International Standard applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment (3.2.46), require well-defined X-ray radiation condition (3.1.6).
Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the radiation beam (3.2.32) (for example by rare earth filters).
X-ray radiation condition (3.1.6) for screen-film sensitometry are not covered in this standard.
NOTE: Screen-film sensitometry is the subject of the ISO 9236 series.
This standard deals with methods for generating X-ray beams characterized by X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment (3.2.46) .
Examples of such are X-ray beams emerging through the filtration from an X-ray source assembly (3.2.51) whereby the radiation field (3.2.34) includes only an insignificant amount of scattered radiation (3.2.38) . X-ray radiation condition (3.1.6) can also represent the more general case, where scattered radiation (3.2.38) emerges from an exit surface (3.1.4) of a patient (3.2.25) or a phantom (3.2.27).
Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the radiation beam (3.2.32) (for example by rare earth filters).
X-ray radiation condition (3.1.6) for screen-film sensitometry are not covered in this standard.
NOTE: Screen-film sensitometry is the subject of the ISO 9236 series.
This standard deals with methods for generating X-ray beams characterized by X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment (3.2.46) .
Examples of such are X-ray beams emerging through the filtration from an X-ray source assembly (3.2.51) whereby the radiation field (3.2.34) includes only an insignificant amount of scattered radiation (3.2.38) . X-ray radiation condition (3.1.6) can also represent the more general case, where scattered radiation (3.2.38) emerges from an exit surface (3.1.4) of a patient (3.2.25) or a phantom (3.2.27).
Alusdokumendid:
IEC 61267:2025; EN IEC 61267:2026
Asendab:
EVS-EN 61267:2006
ISO 24976:2026
Traditional Chinese medicine — Pueraria lobata root
Käsitlusala:
This document specifies the quality and safety requirements of Pueraria lobata root.
This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
Alusdokumendid:
ISO 15883-6:2026
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment
Käsitlusala:
This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.
This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.
The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.
This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.
Alusdokumendid:
Asendab:
ISO 15883-6:2011
ISO 18704:2026
Molecular in vitro diagnostic examinations — Requirements and recommendations for pre-examination processes for urine and other body fluids — Isolated cell-free DNA
Käsitlusala:
This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Alusdokumendid:
ISO 25003:2026
Traditional Chinese medicine — Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome
Käsitlusala:
This document specifies the quality and safety requirements of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome.
This document applies to Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome that is sold and used as natural medicines in international trade, including in Chinese materia medica, in its whole medicinal material, and in decoction pieces derived from these plants.
This document applies to Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome that is sold and used as natural medicines in international trade, including in Chinese materia medica, in its whole medicinal material, and in decoction pieces derived from these plants.
Alusdokumendid:
ISO/TS 21758:2026
Traditional Chinese medicine — General requirements of stick-type package for viscous extracts
Käsitlusala:
This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.
Alusdokumendid:
ISO/TS 7446:2026
Implementation guidance for biorisk management for laboratories and other related organizations
Käsitlusala:
This document provides supplemental information and guidance on how to implement the requirements listed in ISO 35001 [1]. This document does not add requirements to those in ISO 35001 [1].
Alusdokumendid:
Asendatud standardid
EVS-EN 60601-2-64:2015
Elektrilised meditsiiniseadmed. Osa 2-64: Erinõuded kergete ioonide kimbuga kiiritusraviseadmete esmasele ohutusele ja olulistele toimimisnäitajatele
Käsitlusala:
IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of ME equipment intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n.
Key words: nuclear medicine, radiation dosimetry.
Key words: nuclear medicine, radiation dosimetry.
Alusdokumendid:
IEC 60601-2-64:2014; EN 60601-2-64:2015
Asendatud:
EVS-EN IEC 60601-2-64:2026
ISO 15883-6:2011
Washer-disinfectors -- Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Käsitlusala:
ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
Alusdokumendid:
Asendatud:
ISO 15883-6:2026
EVS-EN 50637:2017
Elektrilised meditsiiniseadmed. Erinõuded meditsiiniliste lastevoodite esmasele ohutusele ja olulistele toimimisnäitajatele
Käsitlusala:
201.1 Scope, object and related standards
Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows:
201.1.1 * Scope
Replacement:
This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.
This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.
NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.
If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.
This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52).
This Standard does not apply to :
- incubators covered by EN 60601-2-19 ;
- beds for children, covered by EN 716-1 and EN 716-2 ;
- cribs and cradles covered by EN 1130 (all parts) ;
- bunk beds and high beds, covered by EN 747-1 and 747-2.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006.
NOTE 2 See also 4.2 of EN 60601-1:2006.
NOTE 3 Body length is measured from crown to sole.
Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows:
201.1.1 * Scope
Replacement:
This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.
This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.
NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.
If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.
This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52).
This Standard does not apply to :
- incubators covered by EN 60601-2-19 ;
- beds for children, covered by EN 716-1 and EN 716-2 ;
- cribs and cradles covered by EN 1130 (all parts) ;
- bunk beds and high beds, covered by EN 747-1 and 747-2.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006.
NOTE 2 See also 4.2 of EN 60601-1:2006.
NOTE 3 Body length is measured from crown to sole.
Alusdokumendid:
EN 50637:2017
Asendatud:
EVS-EN IEC 80601-2-89:2026
EVS-EN 61267:2006
Medical diagnostic X-ray equipment – Radiation conditions for use in the determination of characteristics
Käsitlusala:
This International Standard applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined radiation conditions. Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the radiation beam (for example by rare earth filters).
Alusdokumendid:
IEC 61267:2005; EN 61267:2006
Asendatud:
EVS-EN IEC 61267:2026
EVS-EN 62083:2010
Elektrilised meditsiiniseadmed. Nõuded kiiritusravi planeerimissüsteemide ohutusele
Käsitlusala:
This International Standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS) - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or directly from other devices; - that outputs data either in printed form for review or directly to other devices; - and which is intended to be - for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; - maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and - used within the environmental and electrical supply conditions SPECIFIED in the technical description.
Alusdokumendid:
IEC 62083:2009; EN 62083:2009
Asendatud:
EVS-EN IEC 62083:2026
ISO 21370:2019
Traditional Chinese medicine -- Dendrobium officinale stem
Käsitlusala:
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo.
It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Alusdokumendid:
Asendatud:
ISO 21370:2026
Kavandid
EN ISO 4135:2022/prA1
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)
Käsitlusala:
Amendment to EN ISO 4135:2022
Alusdokumendid:
EN ISO 4135:2022/prA1; ISO 4135:2022/DAM 1:2026
prEN ISO 23401-2
Dentistry - Denture lining materials - Part 2: Soft type materials for short-term use (ISO/DIS 23401-2:2026)
Käsitlusala:
This document specifies requirements for soft type denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis, and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer.
This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.
This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.
Alusdokumendid:
ISO/DIS 23401-2; prEN ISO 23401-2
prEN ISO 23401-3
Dentistry - Denture lining materials - Part 3: Soft type materials for long-term use (ISO/DIS 23401-3:2026)
Käsitlusala:
This document specifies requirements for soft type denture lining materials suitable for long-term use and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. These materials may also be used for maxillofacial prostheses.
This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.
This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.
Alusdokumendid:
ISO/DIS 23401-3; prEN ISO 23401-3
prEN ISO 17254
Dentistry - Coiled springs for use in orthodontics (ISO/DIS 17254:2026)
Käsitlusala:
This document is applicable to coil springs for use in orthodontic appliances. This document is not applicable to the devices that are composed by two or more coil springs.
This document gives details of methods to compare the physical and mechanical properties of coil springs, the test methods by which they can be determined, as well as packaging and labelling requirements.
This document gives details of methods to compare the physical and mechanical properties of coil springs, the test methods by which they can be determined, as well as packaging and labelling requirements.
Alusdokumendid:
ISO/DIS 17254; prEN ISO 17254
prEN ISO 9693
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems (ISO/FDIS 9693:2026)
Käsitlusala:
This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.
This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.
This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.
Alusdokumendid:
ISO/FDIS 9693; prEN ISO 9693
prEN ISO 19253
Sterilization of health care products - Moist heat - Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers (ISO/DIS 19253:2026)
Käsitlusala:
Specifies the requirements and the relevant tests for sterilizers intended to be used for the terminal sterilization of health care products (medical devices or medicinal products) presented as aqueous liquid in sealed containers. The container can be rigid, semi rigid or flexible. The sterilizing agent, moist heat, is created internally from the product, heating being achieved by use of saturated steam, mixtures of steam and a pressure ballasting non-condensing gas such as air or super-heated water in the sterilizer chamber. The sterilizers can be used in both a health care and industrial setting.
This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories.
NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards.
NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs.
Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.
This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories.
NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards.
NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs.
Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.
Alusdokumendid:
ISO/DIS 19253; prEN ISO 19253