iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.

11.120 - Pharmaceutics

ICS 11.120 Details

Pharmaceutics

Pharmazie

Pharmacie

Farmacija

General Information

Parent
11 - HEALTH CARE TECHNOLOGY
Sub-Items
11.120.01 - Pharmaceutics in general
11.120.10 - Medicaments
11.120.20 - Wound dressings and compresses
11.120.99 - Other standards related to pharmaceutics

e-Library Subscription

Create subscription and get permanent access to documents within 11.120 - Pharmaceutics

Type
Monthly Subscription
for
seat
×
$ 231.06
$ 231.06

Currently subscription includes documents marked with .We are working on making all documents available within the subscription.

Standardization Organization
Technical Committee
Directive
Mandate
50
ISO
ISO 9299:2024(Main)
Traditional Chinese medicine — Curcuma longa rhizome

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.

  • Standard
    15 pages
    English language
    sale 15% off
ISO
ISO 13619:2024(Main)
Traditional Chinese medicine — Gardenia jasminoides fruit

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.

  • Standard
    13 pages
    English language
    sale 15% off
ISO
ISO 5076:2024(Main)
Traditional Chinese medicine — Angelica dahurica root

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.

  • Standard
    12 pages
    English language
    sale 15% off
ISO
ISO 6904:2024(Main)
Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs

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.

  • Standard
    6 pages
    English language
    sale 15% off
SIST
SIST EN 17854:2024(Main)
Antimicrobial wound dressings - Requirements and test method
EN 17854:2024

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.

  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 17854:2024(Main)
Antimicrobial wound dressings - Requirements and test method
SIST EN 17854:2024

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.

  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO 8071:2024(Main)
Traditional Chinese medicine — Ligusticum chuanxiong rhizome

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.

  • Standard
    14 pages
    English language
    sale 15% off
ISO
ISO/TR 18986:2024(Main)
Traditional Chinese medicine — Report on the global industry and standardization development of Panax ginseng

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 report
    32 pages
    English language
    sale 15% off
SIST
SIST EN 13726:2024(Main)
Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility
EN 13726:2023

This document specifies test methods for the evaluation of aspects of absorption of wound dressings,
test methods for the evaluation of moisture vapour transmission rate of permeable film wound and
fixation dressings, and test methods to assess waterproofness and extensibility.

  • Standard
    70 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO 9319:2024(Main)
Traditional Chinese medicine — Poria cocos sclerotium

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.

  • Standard
    13 pages
    English language
    sale 15% off
ISO
ISO 9109:2024(Main)
Traditional Chinese medicine — Rehmannia glutinosa root

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.

  • Standard
    20 pages
    English language
    sale 15% off
ISO
ISO 20759:2023(Main)
Traditional Chinese medicine — Artemisia argyi leaf

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.

  • Standard
    15 pages
    English language
    sale 15% off
ISO
ISO 9306:2023(Main)
Traditional Chinese medicine — Ephedra sinica, Ephedra intermedia and Ephedra equisetina herbaceous stem

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.

  • Standard
    15 pages
    English language
    sale 15% off
ISO
ISO 7450:2023(Main)
Traditional Chinese medicine — Pinellia ternata tuber

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.

  • Standard
    16 pages
    English language
    sale 15% off
CEN
EN 13726:2023(Main)
Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility
SIST EN 13726:2024

This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.

  • Standard
    70 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO 5228:2023(Main)
Traditional Chinese medicine — Rheum palmatum, Rheum tanguticum and Rheum officinale root and rhizome

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.

  • Standard
    21 pages
    English language
    sale 15% off
ISO
ISO 7177:2023(Main)
Traditional Chinese medicine — Coptis chinensis and Coptis japonica rhizome

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.

  • Standard
    14 pages
    English language
    sale 15% off
ISO
ISO 4564:2023(Main)
Traditional Chinese medicine — Scutellaria baicalensis root

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.

  • Standard
    12 pages
    English language
    sale 15% off
SIST
SIST EN ISO 14375:2023(Main)
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
EN ISO 14375:2023

There are no changes to the content of the EN 14375 document.
This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST-TS CEN ISO/TS 17251:2023(Main)
Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023)
CEN ISO/TS 17251:2023

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 specification
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 14375:2023(Main)
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
SIST EN ISO 14375:2023

This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO/TS 13126:2023(Main)
Traditional Chinese medicine — Determination of ochratoxin A in natural products by liquid chromatography coupled with fluorescence detector

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 specification
    8 pages
    English language
    sale 15% off
ISO
ISO 23416:2023(Main)
General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles

This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.

  • Standard
    16 pages
    English language
    sale 15% off
SIST
SIST EN ISO 11615:2018/A1:2023(Amendment)
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)
EN ISO 11615:2017/A1:2022
  • Amendment
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO 19609-4:2022(Main)
Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 4: Testing for preservatives and unwanted compounds

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.

  • Standard
    22 pages
    English language
    sale 15% off
ISO
ISO 4754:2022(Main)
Traditional Chinese medicine — Fermented Cordyceps powder

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.).

  • Standard
    16 pages
    English language
    sale 15% off
ISO
ISO 19609-3:2022(Main)
Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 3: Testing for contaminants

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.

  • Standard
    11 pages
    English language
    sale 15% off
ISO
IWA 37-3:2022(Main)
Safety, security and sustainability of cannabis facilities and operations — Part 3: Good production practices (GPP)

This document specifies requirements and recommendations for organizations directly or indirectly involved in the cannabis supply chain, to enable them to: — plan, implement, operate, maintain and update a good production practice programme for providing products that are safe, according to their intended use; — demonstrate compliance with applicable statutory and regulatory requirements; — evaluate and assess mutually agreed customer requirements and demonstrate conformity to them; — effectively communicate with interested parties and demonstrate conformity to relevant interested parties; — demonstrate conformity to stated policies in a cannabis quality programme (CQP) for product safety, product quality, product security and facility safety; — support the evaluation of quality programmes by external organizations or to permit self-assessment or self-declaration of adherence to some or all of the guidance contained in this document. All requirements in this document are generic and intended to be applicable to all organizations in the cannabis supply chain, regardless of size and/or complexity. Organizations that are directly or indirectly involved include (but are not limited to) growers/cultivators, harvesters, primary processors, producers of cannabis, manufacturers of cannabis derivatives, cannabis edibles and/or cannabis products, testing providers, retailers and organizations providing transportation, storage and distribution services, suppliers of equipment, packaging materials and other contact materials. This document intended to enable any organization, including small and/or less developed organizations, to implement externally developed elements in its CQP. NOTE 1 Organizations in the cannabis supply chain are diverse in nature and not all the requirements specified in this document apply to each establishment or process. Justifications for exclusions or the use of alternative measures can be documented by a risk assessment/hazard analysis or other appropriate means. This document provides guidance related to the following categories of cannabis, cannabis derivatives and cannabis products: — cannabis plant seeds; — cannabis plants; — fresh cannabis; — dried cannabis; — cannabis derivatives; — cannabis topicals; — inhalable cannabis. NOTE 2 Annex B provides additional guidance on applying GPP to cannabis edibles with respect to requirements and recommendations in existing food safety standards. Where buildings or premises combine cultivation and processing of cannabis plants, including ancillary activities, along with other operational activities, the requirements and recommendations in this document apply only to that portion of the facility. NOTE 3 Where joint use activities are present in a common building, specific statutory and regulatory requirements can apply for each category. This document does not address the following: — requirements related to research and development activities for finished products; — general fire prevention or building construction features that are normally a function of local building and fire codes where applicable; — premises used exclusively for operational activities, such as office space, call centres and retail outlets, used for the distribution, marketing, or sale of cannabis; NOTE 4 Shipping and receiving of products from the production facility for further distribution are not considered as a retail outlet. — the safe consumption or use of the cannabis or cannabis products produced by organizations applying these good production practices; — occupational health and safety requirements governing cannabis workers and personnel except as identified in A.8.4 and A.8.6; — the protection of the environment; — security of the supply chain monitoring system, including cybersecurity and notifications; NOTE 5 Security and monitoring of the supply chain are dealt with specifically in IWA 37-2. — outdoor cultivation of cannabis and industrial hemp; — gr

  • Standardization document
    66 pages
    English language
    sale 15% off
ISO
ISO 24166-2:2022(Main)
Snap-on bottles for metering pumps — Part 2: Moulded glass

This document specifies the shape, dimensions, fill capacities and performance requirements of moulded glass bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document also provides requirements for packaging of the moulded glass bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

  • Standard
    17 pages
    English language
    sale 15% off
ISO
ISO 24166-3:2022(Main)
Snap-on bottles for metering pumps — Part 3: Plastic

This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. The document provides requirements for packaging of the plastic bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

  • Standard
    18 pages
    English language
    sale 15% off
ISO
ISO 24166-1:2022(Main)
Snap-on bottles for metering pumps — Part 1: Tubular glass

This document specifies the shape, dimensions, fill capacities and performance requirements of tubular glass vials for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document provides also requirements for packaging of the tubular glass vials and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber containers made of tubular glass and intended to be used for packaging, storage or transportation of products intended for medicinal use.

  • Standard
    20 pages
    English language
    sale 15% off
ISO
ISO 23964:2022(Main)
Traditional Chinese medicine — Saposhnikovia divaricata root and rhizome

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.

  • Standard
    18 pages
    English language
    sale 15% off
ISO
ISO 23963-2:2022(Main)
Traditional Chinese medicine — Requirements for process traceability system of Chinese materia medica and decoction pieces — Part 2: Electronic labelling

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.

  • Standard
    6 pages
    English language
    sale 15% off
ISO
ISO 23963-1:2022(Main)
Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components

This document specifies the requirements for process traceability systems in Chinese materia medica and decoction pieces, including checkpoints of traceability information about the planting or breeding and circulation of Chinese materia medica, and the manufacturing, processing and use of entities of decoction pieces.

  • Standard
    9 pages
    English language
    sale 15% off
ISO
ISO 4154:2022(Main)
Traditional Chinese medicine — Sinomenium acutum stem

This document specifies the minimum quality and safety requirements of Sinomenium acutum stem [the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.]. This document applies to Sinomenium acutum stem 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.

  • Standard
    10 pages
    English language
    sale 15% off
ISO
ISO 22586:2022(Main)
Traditional Chinese medicine — Paeonia lactiflora root — White peony root

This document specifies the minimum requirements and test methods for white peony root derived from the plant of Paeonia lactiflora Pallas. It is applicable to white peony root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. It is not applicable to red peony root.

  • Standard
    13 pages
    English language
    sale 15% off
ISO
ISO 22585:2022(Main)
Traditional Chinese medicine — Codonopsis pilosula root

This document specifies the minimum requirements and test methods for Codonopsis pilosula root derived from the plant of Codonopsis pilosula (Franch.) Nannf. It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

  • Standard
    14 pages
    English language
    sale 15% off
ISO
ISO 23965:2022(Main)
Traditional Chinese medicine — Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root

This document specifies minimum requirements and test methods for Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root. This document applies to Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

  • Standard
    20 pages
    English language
    sale 15% off
ISO
ISO 23956:2022(Main)
Traditional Chinese medicine — Determination of benzopyrene in processed natural products

This document specifies the method for the determination of benzopyrene content in processed natural products. It is applicable to processed natural products such as processed Rehmannia root, processed Cyperus rhizome, processed ginseng and processed mume fruit. It is not applicable to the analysis of minerals used in traditional Chinese medicine.

  • Standard
    10 pages
    English language
    sale 15% off
ISO
ISO 23419:2021(Main)
Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

  • Standard
    17 pages
    English language
    sale 15% off
  • Standard
    17 pages
    English language
    sale 15% off
SIST
SIST-TS CEN/ISO TS 22703:2021(Main)
Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021)
CEN ISO/TS 22703:2021

This document specifies the requirements for medication safety alert systems and the topics which are
relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs)
whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;
— requirements for choosing a knowledge base for medication safety alert systems;
— requirements for the proper functionality of CDSSs as related to medication safety alert systems;
— requirements for medication safety alert display;
— requirements for quality measurements to improve the effectiveness of medication safety alerts.
The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.

  • Technical specification
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO 23972:2021(Main)
Traditional Chinese medicine — Zingiber officinale rhizome

This document specifies the quality and safety requirements of Zingiber officinale rhizome derived from the plant Zingiber officinale Roscoe, including the minimum requirements and test methods. This document applies to Zingiber officinale 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. It is not applicable to Zingiber officinale rhizome sold and used as food or spices.

  • Standard
    15 pages
    English language
    sale 15% off
  • Standard
    15 pages
    English language
    sale 15% off
ISO
ISO 22467:2021(Main)
Traditional Chinese medicine — Determination of microorganisms in natural products

This document specifies test methods to determine microorganisms in natural products. It is applicable only to natural products used in traditional Chinese medicine, including raw materials, herbal pieces and preparations.

  • Standard
    40 pages
    English language
    sale 15% off
  • Standard
    40 pages
    English language
    sale 15% off
ISO
ISO 23959:2021(Main)
Traditional Chinese medicine — Glehnia littoralis root

This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived from the plant Glehnia littoralis Fr Schmidt ex Miq. This document applies to Glehnia littoralis 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 plant.

  • Standard
    14 pages
    English language
    sale 15% off
  • Standard
    14 pages
    English language
    sale 15% off
ISO
ISO 23723:2021(Main)
Traditional Chinese medicine — General requirements for herbal raw material and materia medica

This document specifies the general requirements and test methods for herbal raw material and materia medica. This document provides minimum requirements for those herbal materials that are not covered by individual standards.

  • Standard
    100 pages
    English language
    sale 15% off
  • Standard
    100 pages
    English language
    sale 15% off
ISO
ISO 23962:2021(Main)
Traditional Chinese medicine — Processed Aconitum carmichaelii lateral root

This document specifies minimum requirements and test methods for processed Aconitum carmichaelii lateral root (lateral root of Aconitum carmichaelii Debx.). This document applies to processed Aconitum carmichaelii lateral root 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 of Aconitum carmichaelii lateral root are excluded.

  • Standard
    16 pages
    English language
    sale 15% off
  • Standard
    16 pages
    English language
    sale 15% off
SIST
SIST EN ISO 22413:2021(Main)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
EN ISO 22413:2021

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
ISO
ISO 23190:2021(Main)
Traditional Chinese medicine — Determination of aristolochic acids in natural products by high-performance liquid chromatography (HPLC)

This document specifies a method for using high-performance liquid chromatography (HPLC) to determine the presence of aristolochic acid I in natural products.

  • Standard
    11 pages
    English language
    sale 15% off
  • Standard
    11 pages
    English language
    sale 15% off
CEN
EN ISO 21976:2020(Main)
Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
SIST EN ISO 21976:2020

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST-TP CEN/TR 17612:2021(Main)
Algae and algae products - Specifications for pharmaceutical sector applications
CEN/TR 17612:2021

This Technical Reports describes quality designations and indications for algae and directly derived products from algae production required for or by pharma producers and industry. It does not apply to Food and Feed sectors.
Note: This TRs does not provide instructions on existing handling of technical requirements in existing legislations.

  • Technical report
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day
50