Infoteenus
11 TERVISEHOOLDUS
Uued standardid
EVS-EN ISO 9693:2026
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems (ISO 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 9693:2026; EN ISO 9693:2026
Asendab: EVS-EN ISO 9693:2019
ISO 9693:2026
Dentistry — Compatibility testing for metal-ceramic and ceramic-ceramic systems
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:
Asendab: ISO 9693:2019
ISO/TS 25144-1:2026
Traditional Chinese medicine — Vocabulary for device — Part 1: moxibustion device
Käsitlusala: This document provides vocabularies and definitions for moxibustion devices.
This document is not applicable to moxibustion-like devices whose heat source is not combustion, e.g. electric moxibustion devices.
This document is not applicable to moxibustion-like devices whose heat source is not combustion, e.g. electric moxibustion devices.
Alusdokumendid:
ISO 21314:2026
Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome
Käsitlusala: This document specifies the requirements and test methods for Salvia miltiorrhiza root and rhizome, which are derived from the Salvia miltiorrhiza Bge. plant.
It is applicable to Salvia miltiorrhiza root and rhizome that are sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.
It is applicable to Salvia miltiorrhiza root and rhizome that are sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.
Alusdokumendid:
Asendab: ISO 21314:2019
ISO 21756:2026
Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome aqueous extract granules
Käsitlusala: This document specifies the technical requirements for the quality and safety of industrial manufacturing procedures and quality of Salvia miltiorrhiza root and rhizome aqueous extract granules. It is applicable to Salvia miltiorrhiza root and rhizome aqueous extract granules that are sold and used in international trade.
Alusdokumendid:
ISO 24902:2026
Traditional Chinese medicine — Zanthoxylum nitidum root
Käsitlusala: This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root.
This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Alusdokumendid:
ISO 10993-3:2026
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
Käsitlusala: This document specifies strategies for risk estimation and evaluation of biological harms with respect to:
genotoxicity;
carcinogenicity;
reproductive toxicity; and
developmental toxicity.
This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.
genotoxicity;
carcinogenicity;
reproductive toxicity; and
developmental toxicity.
This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.
Alusdokumendid:
ISO 8980-3:2022/Amd 1:2026
Ophthalmic optics — Uncut finished spectacle lenses — Part 3: Transmittance specifications and test methods — Amendment 1
Käsitlusala: Amendment to ISO 8980-3:2022
Alusdokumendid:
ISO 18977:2026
Traditional Chinese medicine — Requirements for herbal dispensing services
Käsitlusala: This document specifies the safety and quality requirements for herbal dispensing services. It is applicable to facilities related to large-scale herbal dispensaries, in-house hospital dispensaries and medium to large commercial dispensaries.
It does not apply to dispensing services in medical clinics where herbal preparations are dispensed to patients by or under the supervision of the prescribing practitioners. The specifications regarding tools and equipment used in these services are excluded.
It does not apply to dispensing services in medical clinics where herbal preparations are dispensed to patients by or under the supervision of the prescribing practitioners. The specifications regarding tools and equipment used in these services are excluded.
Alusdokumendid:
ISO 17191:2026
Urine-absorbing products for incontinence — Measurement of airborne respirable polyacrylate superabsorbent materials — Determination of dust in collection cassettes by sodium atomic absorption spectrometry
Käsitlusala: This document specifies a method for the determination of polyacrylate (PA) superabsorbent materials in airborne dust by measurement of sodium (Na) by atomic absorption spectrometry (AAS).
This method is applicable to the determination of collected superabsorbent powder in the range between 0,2 µg and 60 µg (limit of detection near 0,2 µg) of superabsorbent powders.
It is applicable to polyacrylate superabsorbent materials, which occur in hygiene products including urine-absorbing aids for incontinent persons. The test methods are addressed to the material exclusively. They are not intended to be used, and are not applicable for use, with finished manufactured urine-absorbing aids.
This method is applicable to the determination of collected superabsorbent powder in the range between 0,2 µg and 60 µg (limit of detection near 0,2 µg) of superabsorbent powders.
It is applicable to polyacrylate superabsorbent materials, which occur in hygiene products including urine-absorbing aids for incontinent persons. The test methods are addressed to the material exclusively. They are not intended to be used, and are not applicable for use, with finished manufactured urine-absorbing aids.
Alusdokumendid:
Asendab: ISO 17191:2004
ISO 27186:2026
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
Käsitlusala: This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices that have electrogram sensing and pacing functions with or without defibrillation capability. This document includes requirements for the connector portion of an implantable lead and for the mating connector cavity attached to an implantable pulse generator. Key dimensions and performance requirements are specified together with appropriate test methods.
This document establishes two types of connector assembly with their configurations, which are not intended to be interchangeable:
a high-voltage connector: a connector that can have either
two low-voltage contacts combined with one or two high-voltage contacts, or
only two high-voltage contacts;
a “low-voltage only connector”: a connector that has either three or four low-voltage contacts.
This document specifies a dimensional lockout feature that prevents the low-voltage contacts of the lead connectors from contacting the high-voltage contacts of high-voltage connector cavities.
This document does not replace or provide alternatives for unipolar or bipolar connector International Standards that currently exist (such as ISO 11318[2] and ISO 5841-3[1]).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V or systems with an electric flow greater than 50 A.
This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing electrogram sensing or defibrillation functions.
This document does not specify all connector features and it does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
This document does not include requirements for accessories or adaptors used with four-pole connectors. Refer to Annex P for more information on connector-related products.
NOTE 1 The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
NOTE 2 Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
This document establishes two types of connector assembly with their configurations, which are not intended to be interchangeable:
a high-voltage connector: a connector that can have either
two low-voltage contacts combined with one or two high-voltage contacts, or
only two high-voltage contacts;
a “low-voltage only connector”: a connector that has either three or four low-voltage contacts.
This document specifies a dimensional lockout feature that prevents the low-voltage contacts of the lead connectors from contacting the high-voltage contacts of high-voltage connector cavities.
This document does not replace or provide alternatives for unipolar or bipolar connector International Standards that currently exist (such as ISO 11318[2] and ISO 5841-3[1]).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V or systems with an electric flow greater than 50 A.
This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing electrogram sensing or defibrillation functions.
This document does not specify all connector features and it does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
This document does not include requirements for accessories or adaptors used with four-pole connectors. Refer to Annex P for more information on connector-related products.
NOTE 1 The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
NOTE 2 Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
Alusdokumendid:
Asendab: ISO 27186:2020
ISO 22532:2026
Health informatics — Identification of medicinal products — Core vocabulary
Käsitlusala: This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.
Alusdokumendid:
ISO 8961:2026
Traditional Chinese medicine — Areca catechu seed
Käsitlusala: This document specifies the minimum requirements and test methods for Areca catechu seed.
This document applies to Areca catechu seed that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document does not apply to processed decoction pieces of Areca catechu seed.
This document applies to Areca catechu seed that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document does not apply to processed decoction pieces of Areca catechu seed.
Alusdokumendid:
ISO 7835:2026
Traditional Chinese medicine — Schisandra chinensis fruit
Käsitlusala: This document specifies the minimum requirements and test methods for Schisandra chinensis fruit which is derived from Schisandra chinensis (Turcz.) Baill.
It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international trade, including Chinese materia medica.
It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international trade, including Chinese materia medica.
Alusdokumendid:
EVS-EN ISO 5361:2023+A1:2026
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11 + ISO 5361:2023/Amd 1:2026)
Käsitlusala: This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1 There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1 There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
Alusdokumendid: ISO 5361:2023; EN ISO 5361:2023; ISO 5361:2023/Amd 1:2026; EN ISO 5361:2023/A1:2026
Asendatud standardid
ISO 10993-3:2014
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Käsitlusala: ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
Alusdokumendid:
Asendatud: ISO 10993-3:2026
ISO 17191:2004
Urine-absorbing aids for incontinence -- Measurement of airborne respirable polyacrylate superabsorbent materials -- Determination of dust in collection cassettes by sodium atomic absorption spectrometry
Käsitlusala: ISO 17191:2004 specifies a method for the determination of polyacrylate (PA) superabsorbent powders in airborne dust by measurement of sodium (Na) by atomic absorption spectrometry (AAS). PA dust samples are collected in polystyrene acrylonitrile air-monitoring cassettes with polytetrafluoroethylene filters and porous plastic backing pads.
This method is applicable to the determination of collected superabsorbent powder in the range between 0,2 micrograms and 60 micrograms (limit of detection near 0,2 micrograms) of superabsorbent powders.
This method is applicable to the determination of collected superabsorbent powder in the range between 0,2 micrograms and 60 micrograms (limit of detection near 0,2 micrograms) of superabsorbent powders.
Alusdokumendid:
Asendatud: ISO 17191:2026
ISO/TR 10993-33:2015
Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO 10993-3
Käsitlusala: There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this ISO/TR 10993-33: 2015 is to provide background information to facilitate the selection of tests and guidance on the performance of tests.
Alusdokumendid:
Asendatud: ISO 10993-3:2026
EVS-EN ISO 9693:2019
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems (ISO 9693:2019)
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 9693:2019; EN ISO 9693:2019
Asendatud: EVS-EN ISO 9693:2026
ISO 21314:2019
Traditional Chinese medicine -- Salvia miltiorrhiza root and rhizome
Käsitlusala: This document specifies the minimum requirements and test methods for Salvia miltiorrhiza root and rhizome, which is derived from the Salvia miltiorrhiza Bge. plant.
It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.
It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.
Alusdokumendid:
Asendatud: ISO 21314:2026
ISO 9693:2019
Dentistry -- Compatibility testing for metal-ceramic and ceramic-ceramic systems
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:
Asendatud: ISO 9693:2026
ISO 27186:2020
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
Käsitlusala: This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.
NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.
This document does not specify all connector features.
This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.
This document does not specify all connector features.
This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
Alusdokumendid:
Asendatud: ISO 27186:2026
Kavandid
prEN ISO 19223-1
Lung ventilators and related equipment - Vocabulary and semantics - Part 1: Lung ventilators (ISO/DIS 19223-1:2026)
Käsitlusala: This document defines terms for fields of respiratory care involving artificial ventilation, such as intensive care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation.
This document is applicable:
— in lung ventilator and breathing-therapy equipment device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical systems,
— in medical electrical equipment and medical electrical system instructions for use and accompanying information,
— for medical electrical equipment and medical electrical systems interoperability, and
— in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system.
NOTE
This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
This document does not specify terms specific to high-frequency ventilation or jet ventilation, which are defined in ISO 19223-2:2025 [2], terms specific to breathing-therapy equipment, which are defined in ISO 19223-3:2025 [3], or to physiologic closed-loop ventilation, negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.
This document is structured based on the guidance and requirements specified in ISO 704:2022 [4] and ISO 10241-1:2011 [5].
This document is applicable:
— in lung ventilator and breathing-therapy equipment device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical systems,
— in medical electrical equipment and medical electrical system instructions for use and accompanying information,
— for medical electrical equipment and medical electrical systems interoperability, and
— in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system.
NOTE
This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
This document does not specify terms specific to high-frequency ventilation or jet ventilation, which are defined in ISO 19223-2:2025 [2], terms specific to breathing-therapy equipment, which are defined in ISO 19223-3:2025 [3], or to physiologic closed-loop ventilation, negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.
This document is structured based on the guidance and requirements specified in ISO 704:2022 [4] and ISO 10241-1:2011 [5].
Alusdokumendid: ISO/DIS 19223-1; prEN ISO 19223-1
prEN ISO 7396-1
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO/FDIS 7396-1:2026)
Käsitlusala: This document specifies requirements for design, installation, function, performance, testing, commissioning and documentation of medical gas pipeline systems used in healthcare facilities for the following:
— argon;
— pharmacopeial oxygen;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixtures;
— helium/oxygen mixtures;
— gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;
— air for driving surgical tools;
— nitrogen;
— vacuum.
NOTE 1 A rationale for this is contained in Annex I.2
NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396-2[6].
This document includes requirements for supply systems, medical gas pipeline distribution systems, control system(s), monitoring and alarm systems and non-interchangeability between different gas/vacuum systems.
This document specifies safety requirements for medical gas pipeline systems used in healthcare facilities.
It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:
a) acute care healthcare facilities;
b) internal patient continuing care healthcare facilities;
c) long-term care facilities;
d) community-based providers;
e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors’ offices).
This document may also be used as reference for medical gas pipeline systems intended to be installed in places other than healthcare facilities.
This document applies to the following different types of oxygen supply systems:
— supply systems in which all sources of supply deliver oxygen produced off-site;
— supply systems in which some or all sources of supply deliver oxygen produced on-site; in this case the concentration of the oxygen may vary, depending on the pharmacopeial specification selected by the healthcare facility
Oxygen concentrators for domiciliary use are excluded from the scope of this document. This document also applies to:
— extensions of existing pipeline distribution systems;
— modifications of existing pipeline distribution systems;
— modifications or replacement of supply systems or sources of supply.
This document does not apply to vacuum systems intended to be used in dentistry (A rationale is discussed in Annex I.2)
This document does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.
This document does not apply to cryogenic pipeline systems conveying liquified gases.
— argon;
— pharmacopeial oxygen;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixtures;
— helium/oxygen mixtures;
— gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;
— air for driving surgical tools;
— nitrogen;
— vacuum.
NOTE 1 A rationale for this is contained in Annex I.2
NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396-2[6].
This document includes requirements for supply systems, medical gas pipeline distribution systems, control system(s), monitoring and alarm systems and non-interchangeability between different gas/vacuum systems.
This document specifies safety requirements for medical gas pipeline systems used in healthcare facilities.
It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:
a) acute care healthcare facilities;
b) internal patient continuing care healthcare facilities;
c) long-term care facilities;
d) community-based providers;
e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors’ offices).
This document may also be used as reference for medical gas pipeline systems intended to be installed in places other than healthcare facilities.
This document applies to the following different types of oxygen supply systems:
— supply systems in which all sources of supply deliver oxygen produced off-site;
— supply systems in which some or all sources of supply deliver oxygen produced on-site; in this case the concentration of the oxygen may vary, depending on the pharmacopeial specification selected by the healthcare facility
Oxygen concentrators for domiciliary use are excluded from the scope of this document. This document also applies to:
— extensions of existing pipeline distribution systems;
— modifications of existing pipeline distribution systems;
— modifications or replacement of supply systems or sources of supply.
This document does not apply to vacuum systems intended to be used in dentistry (A rationale is discussed in Annex I.2)
This document does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.
This document does not apply to cryogenic pipeline systems conveying liquified gases.
Alusdokumendid: ISO/FDIS 7396-1; prEN ISO 7396-1
prEN 18368
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of virucidal activity on nonporous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2)
Käsitlusala: This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water.
This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the Medical Device Regulation [1] or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods.
This document is applicable for four methods of application of products for wiping and/or mopping:
a) soaking any non-specified wipe or mop with product;
b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop;
c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation;
d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops.
In all types of application the water control has to be conducted with the standard wipe (5.3.2.17 a), because it is process or method control. The contact time for the water control is no longer than 5 min.
This document does not apply to products that are sprayed on or used for flooding of surfaces, without wiping or mopping during the contact time. In this case, the methods of phase 2/ step 2 without mechanical action apply.
The test-surface (5.3.2.16) was selected as a standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface.
This document is applicable to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
— in hospitals, in community medical facilities and in dental institutions;
— in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
NOTE This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the Medical Device Regulation [1] or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods.
This document is applicable for four methods of application of products for wiping and/or mopping:
a) soaking any non-specified wipe or mop with product;
b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop;
c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation;
d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops.
In all types of application the water control has to be conducted with the standard wipe (5.3.2.17 a), because it is process or method control. The contact time for the water control is no longer than 5 min.
This document does not apply to products that are sprayed on or used for flooding of surfaces, without wiping or mopping during the contact time. In this case, the methods of phase 2/ step 2 without mechanical action apply.
The test-surface (5.3.2.16) was selected as a standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface.
This document is applicable to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
— in hospitals, in community medical facilities and in dental institutions;
— in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
NOTE This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Alusdokumendid: prEN 18368
prEN ISO 14729
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO/DIS 14729:2026)
Käsitlusala: This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen.
This International Standard is not applicable to the hygienic management of trial lenses.
NOTE
General disinfection product standards are not applicable to contact lens care products, e.g. EN 1040:1997 and EN 1275:1997.
This International Standard is not applicable to the hygienic management of trial lenses.
NOTE
General disinfection product standards are not applicable to contact lens care products, e.g. EN 1040:1997 and EN 1275:1997.
Alusdokumendid: ISO/DIS 14729; prEN ISO 14729