11.120.10 - Medicaments
ICS 11.120.10 Details
Medicaments
Medikamente
Médicaments
Zdravila
General Information
Frequently Asked Questions
ICS 11.120.10 is a classification code in the International Classification for Standards (ICS) system. It covers "Medicaments". 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 156 standards classified under ICS 11.120.10 (Medicaments). 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.
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 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 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 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 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 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 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 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 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 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 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 the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum chuanxiong Hort.). This document applies to Ligusticum chuanxiong 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.
- Standard14 pagesEnglish languagesale 15% off
This document reports on the global industry and standardization development of Panax ginseng. It includes its origin and application history, medicinal value, geographical distribution, cultivation and processing methods, industry development, international trade, current status and development demands for standardization.
- Technical report32 pagesEnglish languagesale 15% off
This document specifies the quality, safety requirements and test methods for Poria cocos sclerotium that is derived from the fungus Poria cocos (Schw.) Wolf. It is applicable to Poria cocos sclerotium 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 requirements and test methods for dried Rehmannia glutinosa root that is derived from Rehmannia glutinosa Libosch. Fresh Rehmannia glutinosa Libosch. and processed Rehmannia glutinosa Libosch. are excluded. This document is applicable to Rehmannia glutinosa root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard20 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods of Artemisia argyi leaf for medicinal use. It is suitable for identification and quality control of this herbal medicine.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Ephedra herbaceous stem, which is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bge. (Fam. Ephedraceae). This document applies to Ephedra herbaceous stem 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.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Pinellia ternata tuber, including raw and processed Pinellia ternata tuber [dried tuber of Pinellia ternata (Thunb.) Breit.]. This document does not cover processing methods of Pinellia ternata tuber. This document is applicable to raw and processed Pinellia ternata tuber that are sold and used as natural medicines in international trade, including Chinese materiamedica (whole medicinal material) and decoction pieces derived from this plant.
- Standard16 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Rheum root and rhizome (the dried root and rhizome of Rheum palmatum Linne., Rheum tanguticum Maxim. ex Balf. and Rheum officinale Baill.). This document applies to Rheum 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 these plants. This document does not apply to the processing methods and processed products of Rheum root and rhizome.
- Standard21 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Coptis rhizome (the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.). This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processed Coptis rhizome, including products traditionally processed with different methods, or its processing methods.
- Standard14 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for root of Scutellaria baicalensis, which is derived from cultivated Scutellaria baicalensis Georgi. This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard12 pagesEnglish languagesale 15% off
This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.
- Technical specification23 pagesEnglish languagee-Library read for1 day
This document specifies the determination of ochratoxin A (OTA) in natural products by the liquid chromatography coupled with fluorescence detector (LC-FLD) method. It is applicable to the analysis of OTA in raw materials and manufactured products, including decoction pieces derived from plants and animals. It is suitable for samples during the processes of harvesting, transportation and storage, as well as domestic and foreign trade for quality classification.
- Technical specification8 pagesEnglish languagesale 15% off
- Amendment8 pagesEnglish languagee-Library read for1 day
This document specifies the testing of preservatives and unwanted compounds within a quality control framework for starting materials and finished products used in and as traditional Chinese medicine.
- Standard22 pagesEnglish languagesale 15% off
This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).
- Standard16 pagesEnglish languagesale 15% off
This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw materials and finished products used in traditional Chinese medicine.
- Standard11 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide is intended to provide guidance regarding the use of risk management in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating Process Analytical Technology (PAT). A consistent approach to the use of risk methodologies should be adopted to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate.
4.2 This guidance only covers those aspects of risk assessment related to “risk to product quality.” Other aspects (such as “risk to patient”) should be covered in the conventional manner.
SCOPE
1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Guide E2500 and ICH Q8.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Note that safety in this context refers to operational and operator safety, not to patient safety.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide11 pagesEnglish languagesale 15% off
- Guide11 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Saposhnikovia divaricata root and rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk. It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard18 pagesEnglish languagesale 15% off
This document specifies the content of electronic labelling in the form of QR codes on the outer packing of Chinese materia medica and decoction pieces. This document is applicable to the cultivation, production, sales, use units and consumers of Chinese materia medica and decoction pieces.
- Standard6 pagesEnglish languagesale 15% off