Infoteenus
11 TERVISEHOOLDUS
Uued standardid
ISO/TS 7552-1:2024
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNA
Käsitlusala:
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, RNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of RNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory-developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-1.
This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
This document is applicable to molecular in vitro diagnostic examinations including laboratory-developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-1.
This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Alusdokumendid:
ISO 15883-3:2024
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
Käsitlusala:
This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
Alusdokumendid:
Asendab:
ISO 15883-3:2006
EVS-EN IEC 80601-2-49:2019+A1:2024
Elektrilised meditsiiniseadmed. Osa 2-49: Erinõuded multifunktsionaalse patsiendimonitori esmasele ohutusele ja olulistele toimimisnäitajatele
Käsitlusala:
This part of the 80601 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS.
NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT.
This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG, invasive pressure and pulse oximetry. The particular standards related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards also apply.
EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12 also applies.
EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT where ISO 80601-2-72 also applies.
EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also applies.
EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 60601-2-16 also applies.
This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.
The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS.
NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT.
This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG, invasive pressure and pulse oximetry. The particular standards related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards also apply.
EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12 also applies.
EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT where ISO 80601-2-72 also applies.
EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also applies.
EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 60601-2-16 also applies.
This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.
Alusdokumendid:
IEC 80601-2-49:2018; EN IEC 80601-2-49:2019; IEC 80601-2-49:2018/AMD1:2024; EN IEC 80601-2-49:2019/A1:2024
EVS-EN 556-2:2024
Meditsiiniseadmete steriliseerimine. Nõuded meditsiiniseadmetele, mis peavad kandma märgistust "STERIILNE". Osa 2: Nõuded aseptiliselt töödeldud meditsiiniseadmetele
Käsitlusala:
This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
Alusdokumendid:
EN 556-2:2024
Asendab:
EVS-EN 556-2:2015
ISO 11979-2:2024
Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
Käsitlusala:
This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).
Alusdokumendid:
Asendab:
ISO 11979-2:2014
ISO 15883-2:2024
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
Käsitlusala:
This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.
NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.
NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
Alusdokumendid:
Asendab:
ISO 15883-2:2006
ISO/TR 11797:2024
Ophthalmic optics – Spectacle lenses – Power and prism measurements
Käsitlusala:
This document describes the methods currently used in applying tolerances to the focal powers of spectacle lenses and methods that can be considered for adoption in the future; it also describes methods of measuring the prism imbalance (relative prism error) between the lenses of a mounted pair. The results of a 2014 survey of manufacturing capability for lens power and a 2018 international web survey are discussed, as are possible new methods for applying tolerances to the focal power of spectacle lenses.
Alusdokumendid:
IEC 63240-1:2024
Active assisted living (AAL) reference architecture and architecture model - Part 1: Reference architecture
Käsitlusala:
IEC 63240-1:2024 is available as IEC 63240-1:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 63240-1:2024 specifies the AAL reference architecture. This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components. This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience) and sets up a process to identify the needs on the body area network (BAN), edge and cloud computing in the architecture perspective.
IEC 63240-1:2024 cancels and replaces the first edition published in 2020. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) clarifying the Introduction;
b) new terms and definitions have been added in 3.1;
c) adaption of terms according to the IEV in the whole document;
d) reference to ethical considerations of AI when applied in the AAL context has been added in Clause 5;
e) clarifying the description of AAL reference architecture in 6.3.1;
f) process to identify the needs on BAN, edge and cloud computing in the architecture perspective has been added in 6.3.2 and 6.3.3;
g) new figures have been added in 6.3.2 and 6.3.3;
h) reference to standards inventory has been added in 7.1;
i) clarification of 7.5;
j) Annex A has been added;
k) updated bibliography.
IEC 63240-1:2024 cancels and replaces the first edition published in 2020. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) clarifying the Introduction;
b) new terms and definitions have been added in 3.1;
c) adaption of terms according to the IEV in the whole document;
d) reference to ethical considerations of AI when applied in the AAL context has been added in Clause 5;
e) clarifying the description of AAL reference architecture in 6.3.1;
f) process to identify the needs on BAN, edge and cloud computing in the architecture perspective has been added in 6.3.2 and 6.3.3;
g) new figures have been added in 6.3.2 and 6.3.3;
h) reference to standards inventory has been added in 7.1;
i) clarification of 7.5;
j) Annex A has been added;
k) updated bibliography.
Alusdokumendid:
Asendab:
IEC 63240-1:2020
ISO 16971-1:2024
Ophthalmic instruments — Optical coherence tomographs — Part 1: Optical coherence tomographs for the posterior segment of the human eye
Käsitlusala:
This document is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.
This document specifies characteristics and minimum requirements for OCT instruments and systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document.
NOTE In this document the term OCT refers to ophthalmic applications.
This document specifies characteristics and minimum requirements for OCT instruments and systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document.
NOTE In this document the term OCT refers to ophthalmic applications.
Alusdokumendid:
Asendab:
ISO 16971:2015
ISO/TS 7552-3:2024
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC staining
Käsitlusala:
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers, and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers, and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Alusdokumendid:
ISO/TS 7552-2:2024
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNA
Käsitlusala:
This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, DNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2.
This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom or the pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.
This document does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2.
This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom or the pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).
NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
Alusdokumendid:
Asendatud standardid
EVS-EN 556-2:2015
Meditsiiniseadmete steriliseerimine. Nõuded meditsiiniseadmetele vastavuseks märgistusele "Steriilne". Osa 2: Nõuded aseptiliselt töödeldud meditsiiniseadmetele
Käsitlusala:
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
Alusdokumendid:
EN 556-2:2015
Asendatud:
EVS-EN 556-2:2024
ISO 15883-2:2006
Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
Käsitlusala:
Alusdokumendid:
Asendatud:
ISO 15883-2:2024
ISO 15883-3:2006
Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
Käsitlusala:
ISO 15883-3:2006 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle.
ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.
ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.
Alusdokumendid:
Asendatud:
ISO 15883-3:2024
ISO 16971:2015
Ophthalmic instruments -- Optical coherence tomograph for the posterior segment of the human eye
Käsitlusala:
ISO 16971:2015 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.
ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.
ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.
ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.
ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.
Alusdokumendid:
Asendatud:
ISO 16971-1:2024
IEC 63240-1:2020
Active assisted living (AAL) reference architecture and architecture model - Part 1: Reference architecture
Käsitlusala:
IEC 63240-1:2020 specifies the AAL reference architecture.
This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components.
This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).
This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components.
This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).
Alusdokumendid:
Asendatud:
IEC 63240-1:2024
ISO 11979-2:2014
Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
Käsitlusala:
ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ?IOL' used throughout ISO 11979-2:2014 also includes phakic intraocular lenses (PIOL).
Alusdokumendid:
Asendatud:
ISO 11979-2:2024
Kavandid
prEN ISO 17966
Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/DIS 17966:2024)
Käsitlusala:
This document specifies requirements and associated test methods for assistive products
for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document)
and which are considered to be medical devices, intended by the manufacturer to alleviate or
compensate for disability.
NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others.
The work environment and safety aspects for assistants are also included. It specifies safety and
performance requirements that apply during normal use and foreseeable misuse and failure. It also
specifies methods of measurement of the forces necessary to operate controls and specifies limits on
the forces needed for some operations.
This document specifies requirements and test methods for assistive products within the
following divisions of ISO 9999:
09 12 03 Commode chairs;
09 12 06 Toilets;
09 12 09 Toilet seats;
09 12 10 Toilet splash guards;
09 12 12 Raised toilet seats mounted on frame;
09 12 15 Toilet seats inserts;
09 12 18 Raised toilet seats fixed to toilet;
09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
09 12 25 Toilet arm supports and toilet back supports, free standing;
09 12 36 Douches and air dryers for attachment to a toilet;
09 33 04 Bath boards
09 33 05 Bath seats
09 33 07 Shower chairs with and without wheels
09 33 08 Back supports for bath or shower
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are
covered by EN 12221-1 and EN 12221-2.
09 33 15 Wash basins
NOTE: General requirements for wash basins are covered by EN 14688.
09 33 18 Bidets
09 33 21 Bathtubs
09 33 36 Assistive products for drying oneself
18 15 06 Height adjustable plinths and brackets;
18 18 03 Handrails and support rails;
18 18 06 Fixed grab bars and handgrips;
18 18 10 Removable grab rails and handgrips;
18 18 11 Hinged rails and arm supports;
This document does not encompass requirements regarding:
— safe mounting in building structures;
— fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation
to excretion-disposal and -wrapping systems;
— 12 36 15 bathtub hoists that are covered by ISO 10535;
— 09 33 21 Bathtubs
— stability and friction issues in relation to slippery surfaces due to soap;
— products that have been customised or custom-made for an individual user.
NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022
for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document)
and which are considered to be medical devices, intended by the manufacturer to alleviate or
compensate for disability.
NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others.
The work environment and safety aspects for assistants are also included. It specifies safety and
performance requirements that apply during normal use and foreseeable misuse and failure. It also
specifies methods of measurement of the forces necessary to operate controls and specifies limits on
the forces needed for some operations.
This document specifies requirements and test methods for assistive products within the
following divisions of ISO 9999:
09 12 03 Commode chairs;
09 12 06 Toilets;
09 12 09 Toilet seats;
09 12 10 Toilet splash guards;
09 12 12 Raised toilet seats mounted on frame;
09 12 15 Toilet seats inserts;
09 12 18 Raised toilet seats fixed to toilet;
09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
09 12 25 Toilet arm supports and toilet back supports, free standing;
09 12 36 Douches and air dryers for attachment to a toilet;
09 33 04 Bath boards
09 33 05 Bath seats
09 33 07 Shower chairs with and without wheels
09 33 08 Back supports for bath or shower
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are
covered by EN 12221-1 and EN 12221-2.
09 33 15 Wash basins
NOTE: General requirements for wash basins are covered by EN 14688.
09 33 18 Bidets
09 33 21 Bathtubs
09 33 36 Assistive products for drying oneself
18 15 06 Height adjustable plinths and brackets;
18 18 03 Handrails and support rails;
18 18 06 Fixed grab bars and handgrips;
18 18 10 Removable grab rails and handgrips;
18 18 11 Hinged rails and arm supports;
This document does not encompass requirements regarding:
— safe mounting in building structures;
— fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation
to excretion-disposal and -wrapping systems;
— 12 36 15 bathtub hoists that are covered by ISO 10535;
— 09 33 21 Bathtubs
— stability and friction issues in relation to slippery surfaces due to soap;
— products that have been customised or custom-made for an individual user.
NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022
Alusdokumendid:
ISO/DIS 17966; prEN ISO 17966
prEN ISO 10451
Dentistry - Contents of technical file for dental implant systems (ISO/DIS 10451:2024)
Käsitlusala:
This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that may include:
— implant body,
— implant abutment,
— abutment screw,
— implant connecting part
— implant connecting part screw
— prosthetic screw,
— implant cover screw,
— transmucosal healing component.
This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
The following devices are not included within the scope of this document:
— Dental implant incorporating animal or human components or bioactive characteristics,
— Custom-made devices that have no pre-fabricated connection,
— Implantable materials for bone filling and augmentation in oral and maxillofacial surgery,
— Membrane materials for guided tissue regeneration in oral and maxillofacial surgery,
— Specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 gives the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 gives the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3 Custom made devices are defined in the following document IMDRF/PMD WG/N49 - Definitions for Personalized Medical Devices.
— implant body,
— implant abutment,
— abutment screw,
— implant connecting part
— implant connecting part screw
— prosthetic screw,
— implant cover screw,
— transmucosal healing component.
This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
The following devices are not included within the scope of this document:
— Dental implant incorporating animal or human components or bioactive characteristics,
— Custom-made devices that have no pre-fabricated connection,
— Implantable materials for bone filling and augmentation in oral and maxillofacial surgery,
— Membrane materials for guided tissue regeneration in oral and maxillofacial surgery,
— Specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 gives the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 gives the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3 Custom made devices are defined in the following document IMDRF/PMD WG/N49 - Definitions for Personalized Medical Devices.
Alusdokumendid:
ISO/DIS 10451; prEN ISO 10451