11.120 - Pharmaceutics
ICS 11.120 Details
Pharmaceutics
Pharmazie
Pharmacie
Farmacija
General Information
Frequently Asked Questions
ICS 11.120 is a classification code in the International Classification for Standards (ICS) system. It covers "Pharmaceutics". 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 464 standards classified under ICS 11.120 (Pharmaceutics). 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 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
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
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 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 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 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
This document specifies the minimum requirements and test methods for Isatis indigotica root derived from the plant Isatis indigotica Fort. It is applicable to Isatis indigotica roots that are sold as Chinese material medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard14 pagesEnglish languagesale 15% off
This document provides requirements and recommendations related to the concepts required to associate pharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical product identifiers and the related elements are intended to represent pharmaceutical products as defined within a medicinal product by a medicines regulatory authority. While the ISO standards on IDMP can be applied to off-label usage of medicinal products, such applications are currently outside of the scope of this document.
Reference to ISO 11238, ISO 11239, ISO 11240, ISO 11615, HL7 V3 messaging standards (HL7 Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured Product Labelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context of this document.
- Technical specification75 pagesEnglish languagee-Library read for1 day
This document provides requirements on identification and labelling of medicinal products from the point of manufacturing of packaged medicinal product to the point of dispensing the product.
This document outlines commonly accepted international practices for automatic identification and data capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare facilities and all parties involved in labelling and distribution of packaged medicinal products. These users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio frequency identification (RFID); that technology is not addressed in this document except as for information.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for the determination of marker residues of nicarbazin (4,4-dinitrocarbanilide) in chicken tissue and eggs. This document is applicable to the determination of marker residues of nicarbazin (4,4-dinitrocarbanilide) in chicken tissue (including muscle, liver and kidney) and eggs.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the general requirements, content and writing requirements for the prescription of decoction pieces. It notably regulates the qualification of prescription writing, the prescription of precious medicines, the prescription of toxic and anaesthetic medicines, and institution-based prescriptions. This document applies to prescription writing, dispensing and storage.
- Technical specification14 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Ziziphus jujuba fruit. This document is applicable to Ziziphus jujuba fruit that is sold and used as herbal raw materials in the international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.
- Standard11 pagesEnglish languagesale 15% off
This document is applicable to type D and type SD hose assemblies with hoses made of elastomers and bonded plastics for the transport of gaseous, vaporous, liquid or powdery substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −30 °C to +100 °C, depending on the medium, and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Table 2 and Table 3). For hoses with a lining made of PTFE and derivatives, temperatures from −30 °C to +140 °C are permissible.
Hose assemblies in accordance with this document are classified into four types, A – D, A – SD. B – D, B – SD.
- Standard23 pagesEnglish languagee-Library read for1 day
This document specifies the general principles for the establishment of herbal reference substances, covering production, quality control, report, instruction and labelling, packaging, storage and transportation. This document applies to herbal reference substances that are sold and used as reference standards for the quality control of herbal medicines in international trade, including raw materials and finished products.
- Standard8 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem derived from the plant of Cistanche deserticola Y.C. Ma. It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the general technical requirements for the process of cultivation and collection of medicinal plants, including selection of site, seeds and other propagation materials, cultivation, harvest and collection, post-harvest processing, packaging and labelling, storage and transportation. This document applies to the cultivation, harvest and collection of medicinal plants used as the source for herbal medicines, including certain post-harvest operations. This document also provides practical record formats for the entire process.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the minimum quality and safety requirements for Crocus sativus stigma. It applies to Crocus sativus stigma that is sold and used as natural medicines in international trade, including in Chinese materia medica and decoction pieces.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the quality, safety requirements and test methods for Euodia fruit. It is applicable to Euodia fruit that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome. This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard10 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to the Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.
- Standard15 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Curcuma rhizome (Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome). It is applicable to the Curcuma rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant. This document does not apply to the processing methods and processed products of Curcuma rhizome.
- Standard18 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome. This document applies to Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome that is sold and used as natural medicines in international trade, including in Chinese materia medica, in its whole medicinal material, and in decoction pieces derived from these plants.
- Standard16 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Pueraria lobata root. This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
- Standard18 pagesEnglish languagesale 15% off
This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.
- Technical specification6 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.
- Standard17 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Aconitum carmichaelii parent root tuber. This document applies to Aconitum carmichaelii parent root tuber 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. Processing methods and processed products of Aconitum carmichaelii parent root tuber are excluded.
- Standard10 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Polygonum multiflorum root, which is derived from the dried root of Polygonum multiflorum Thunb. (Fam. Polygonaceae). This document is applicable to raw and processed Polygonum multiflorum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard17 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard15 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for sporoderm-broken Ganoderma lucidum spore powder that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as natural medicine and raw material for health products in international trade.
- Technical specification17 pagesEnglish languagesale 15% off
This document specifies the methods for microscopic examination of medicinal herbs. It covers the equipment, sampling, preparation and observation methods. This document is applicable to medicinal herbs used in traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants. It is not applicable to medicinal materials derived from animals or minerals.
- Technical specification10 pagesEnglish languagesale 15% off
This document specifies the requirements and test methods of Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and seedlings. This document is applicable to Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and Glycyrrhiza uralensis seedlings that are sold for the production of Glycyrrhiza uralensis and Glycyrrhiza glabra root as natural medicines in international trade including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Dioscorea opposita rhizome (dried rhizome of Dioscorea opposita Thunb.). It is applicable to Dioscorea opposita rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard10 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Polygala tenuifolia and Polygala sibirica root. It applies to Polygala tenuifolia and Polygala sibirica root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Cinnamomum cassia branch derived from Cinnamomum cassia Presl. This document is applicable to Cinnamomum cassia branch that is sold as natural medicines in international trade including Chinese materia medica (whole medicinal materials) and decoction pieces derived from Cinnamomum cassia Presl.
- Standard15 pagesEnglish languagesale 15% off
This document provides a reference of single herbal medicines in order of their priority in the development of international standards. This document also provides a reference of the principles and the methodology for the priority evaluation of single herbal medicines. In addition to text written in the official ISO languages (English, French, Russian), this document gives text in Chinese. This text is published under the responsibility of the Member Body for China (SAC) and is given for information only. Only the text given in the official languages can be considered as ISO text.
- Technical report97 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Carthamus tinctorius flower that is derived from Carthamus tinctorius Linné. It is applicable to Carthamus tinctorius flower that is sold and used as Chinese materia medica.
- Standard16 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Glycyrrhiza root and rhizome that is derived from the root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L. (Fam. Fabaceae). This document applies to Glycyrrhiza root and rhizome 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.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the application of simplified accelerated stress simulation methods for stress tests of finished products, used in and as Traditional Chinese medicine (TCM). Testing for stability or degradation under the influence of daylight or sunlight is outside the scope of this document.
- Standard23 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark. It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces. It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.
- Standard16 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is derived from Atractylodes macrocephala Koidz. It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard12 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Curcuma longa rhizome. This document applies to the production and sale of cultivated Curcuma longa rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Gardenia jasminoides fruit, which is derived from the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae). This document is applicable to Gardenia jasminoides fruit that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Angelica dahurica root [the dried root of Angelica dahurica (Fish.ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav.]. This document applies to Angelica dahurica root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard12 pagesEnglish languagesale 15% off
This document specifies general requirements for ultrafine powder of herbs to ensure their quality and safety. This document applies to ultrafine powder of herbs that are sold and used as natural medicines in international trade, including finished products derived from this powder.
- Standard6 pagesEnglish languagesale 15% off
This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.
- Standard47 pagesEnglish languagee-Library read for1 day