11 - HEALTH CARE TECHNOLOGY
ICS 11 Details
HEALTH CARE TECHNOLOGY
MEDIZINTECHNIK
TECHNOLOGIES DE LA SANTE
ZDRAVSTVENO VARSTVO
General Information
Frequently Asked Questions
ICS 11 is a classification code in the International Classification for Standards (ICS) system. It covers "HEALTH CARE TECHNOLOGY". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 11652 standards classified under ICS 11 (HEALTH CARE TECHNOLOGY). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies general requirements for the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
- Standard15 pagesEnglish languagesale 15% off
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.
- Standard53 pagesEnglish languagee-Library read for1 day
This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss. This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services. The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices. Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care. Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM. It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.
- Standard42 pagesEnglish languagesale 15% off
- Standard46 pagesFrench languagesale 15% off
This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies. This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring. This document applies to both preformed sterile barrier systems and sterile barrier systems. This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management. This document is intended to be used prior to process validation. NOTE ISO 11607-2 provides requirements for process specification and process validation.
- Standard27 pagesEnglish languagesale 15% off
- Standard31 pagesFrench languagesale 15% off
This document specifies general requirements for the basic safety and essential performance of transcutaneous electrical acupoint stimulators (TEAS) with a focus on devices intended to stimulate acupoints on the human body. It applies to all types of TEAS specifically designed for acupoint-related therapeutic usage, only in the context of professional traditional Chinese medicine (TCM) healthcare services. It is not applicable to invasive electro-acupuncture stimulators for the application of electric currents via acupuncture needles inserted into the body.
- Standard9 pagesEnglish languagesale 15% off
This document specifies the general requirements for basic safety and essential performance of electric radial pulse tonometric devices. This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic data obtained from the use of such devices. This document applies to pressure-based radial pulse tonometric devices.
- Standard9 pagesEnglish languagesale 15% off
- Amendment10 pagesEnglish languagee-Library read for1 day
- Standard10 pagesFrench languagesale 15% off
- Standard19 pagesEnglish and French languagesale 15% off
IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. 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. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.
- Standard73 pagesEnglish languagesale 15% off
- Standard54 pagesEnglish languagesale 15% off
- Standard48 pagesEnglish and French languagesale 15% off
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.
- Draft30 pagesEnglish languagee-Library read for1 day
- Amendment40 pagesEnglish languagee-Library read for1 day
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.
- Standard53 pagesEnglish languagee-Library read for1 day
This document specifies the general requirements and test methods of Chuzhen instruments. It is only applicable to non-disposable Chuzhen instruments. It is not applicable for any disposable Chuzhen instruments or for those with electrical, heat-storing, or other special characteristics.
- Technical specification11 pagesEnglish languagesale 15% off
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements. This document is applicable to polymer-based crown and veneering materials for laboratory fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.
- Standard25 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
This document provides requirements and recommendations on the conditions (means of delivery) and minimum required information to deliver when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). The content of the eIFU is not in the scope of this standard, as it is covered by the documents in the ISO 18113 series.
- Standard6 pagesEnglish languagesale 15% off
This document defines terms for surgical instruments and their components.
- Standard51 pagesEnglish languagesale 15% off
This document specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices.
This document is applicable to dentifrices, including toothpastes, destined to be used by consumers on a daily basis with a toothbrush to promote oral hygiene.
This document does not apply to specific qualitative and quantitative requirements for freedom from biological and toxicological hazards. These are covered in ISO 7405 and ISO 10993-1.
- Standard30 pagesEnglish languagee-Library read for1 day
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.
- Standard18 pagesEnglish languagee-Library read for1 day
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
- Standard30 pagesEnglish languagee-Library read for1 day
This document describes a wear testing method of anatomic total shoulder-joint prostheses that specifies relative motion between the implant components and the pattern of the applied forces. This document includes the basic configuration of the simulator, sample number and alignment, test environment, speed and duration of testing, verification of inputs, measurement of kinematics and other details of the procedure and reporting. The primary outcome is the evaluation of wear performance of total anatomic shoulder-joint prostheses, which includes both qualitative and quantitative methods. The qualitative methods of wear evaluation are included in this document and the methods of quantitative wear measurement are covered in ISO 14243-2.
- Standard32 pagesEnglish languagesale 15% off
- Standard33 pagesFrench languagesale 15% off
This document specifies the material, performance requirements and labelling, and gives recommendations for shape and dimensions of glass cylinders used in cartridge-type needle-based injection systems (NIS) for medical use, according to ISO 11608-3. This document applies to the glass cylinders as supplied by the manufacturer.
- Standard10 pagesEnglish languagesale 15% off
This document specifies methods by which the measurement of irradiance (fluence) distribution is made and specifies parameters for the characterization of the spatial properties of laser irradiance (fluence) distribution functions at a given plane.
The methods given in this document are intended to be used for the testing and characterization of both continuous wave (cw) and pulsed laser beams used in optics and optical instruments.
This document provides definitions of terms and symbols to be used in referring to irradiance distribution, as well as requirements for its measurement. For pulsed lasers, the distribution of time-integrated irradiance (i.e. radiant exposure) is the quantity most often measured.
- Standard26 pagesEnglish languagee-Library read for1 day
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (e.g. headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.
- Standard18 pagesEnglish languagee-Library read for1 day
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard32 pagesEnglish languagee-Library read for1 day
This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.
- Draft35 pagesEnglish languagee-Library read for1 day
- Amendment40 pagesEnglish languagee-Library read for1 day
- Amendment10 pagesEnglish languagee-Library read for1 day
IEC 80601-2-52:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included in the scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable functions.
This document is applicable to either a BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM or both. The combination of BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM with a compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
This document does not apply to:
- MEDICAL BEDS for CHILDREN and ADULTS with atypical anatomies (ADULTS ranging outside the definition for ADULTS in 202.3.222) covered by IEC 80601-2-89;
- SPECIALITY MATTRESS covered by ISO 20342 series;
- devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table);
- all requirements for MEDICAL BEDS with special functionality.
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 BED and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
- Standard103 pagesEnglish languagee-Library read for1 day
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
- Standard30 pagesEnglish languagee-Library read for1 day
- Standard34 pagesEnglish languagesale 15% off
- Standard36 pagesFrench languagesale 15% off
- Standard34 pagesEnglish languagesale 15% off
- Standard36 pagesFrench languagesale 15% off
This document specifies the minimum requirements and test methods for Sophora tonkinensis root and rhizome. This document applies to Sophora tonkinensis root and rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard13 pagesEnglish languagesale 15% off
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.
- Standard12 pagesEnglish languagesale 15% off
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.
- Standard12 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.
- Standard31 pagesEnglish languagesale 15% off
- Standard32 pagesFrench languagesale 15% off
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.
- Standard16 pagesEnglish languagesale 15% off
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.
- Standard41 pagesEnglish languagesale 15% off
- Standard45 pagesFrench languagesale 15% off
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.
- Standard18 pagesEnglish languagee-Library read for1 day
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.
- Technical specification8 pagesEnglish languagesale 15% off
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.
- Standard15 pagesEnglish languagesale 15% off
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.
- Standard16 pagesEnglish languagesale 15% off
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.
- Standard10 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
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.
- Standard9 pagesEnglish languagesale 15% off
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.
- Standard107 pagesEnglish languagesale 15% off
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (e.g. headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.
- Standard18 pagesEnglish languagee-Library read for1 day
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.
- Standard16 pagesEnglish languagesale 15% off