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Biopharmaceuticals 1

Biopharmaceuticals 1, Total:498 items.

In the international standard classification, Biopharmaceuticals 1 involves: Vocabularies, Pharmaceutics, HEALTH CARE TECHNOLOGY, Environmental protection, Quality, Pesticides and other agrochemicals, Water quality, Veterinary medicine, Farming and forestry, Pipeline components and pipelines, Medical equipment, Microbiology, Animal feeding stuffs, Medical sciences and health care facilities in general, Test conditions and procedures in general, Company organization and management, Occupational safety. Industrial hygiene, Seals, glands, Fertilizers, Fuels, Products of the chemical industry, Soil quality. Pedology, Biology. Botany. Zoology, Wastes, Services, Air quality, Graphical symbols, Rubber and plastics products, Sterilization and disinfection, Applications of information technology, Energy and heat transfer engineering in general, Milk and milk products, Standardization. General rules.


American Society for Testing and Materials (ASTM), Biopharmaceuticals 1

  • ASTM E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
  • ASTM E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
  • ASTM E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
  • ASTM E3077-17 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
  • ASTM E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
  • ASTM E1567-93 Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
  • ASTM E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
  • ASTM E2500-07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E3077-17e1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
  • ASTM E3230-20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing
  • ASTM E1298-89(2000) Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
  • ASTM E1298-89(1994) Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
  • ASTM E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

ET-QSAE, Biopharmaceuticals 1

Shanghai Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB31/ 373-2010 Pollutant Discharge Standards for the Biopharmaceutical Industry
  • DB31/ 310005-2021 Emission Standards of Air Pollutants for the Pharmaceutical Industry

Zhejiang Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB33/ 923-2014 Pollutant Discharge Standards for Biopharmaceutical Industry
  • DB33/T 2110.1-2018 Experimental Animal Gerbil Part 1: Microbiological Control Levels and Monitoring
  • DB33/ 310005-2021 Emission Standards of Air Pollutants for the Pharmaceutical Industry

ISA - International Society of Automation, Biopharmaceuticals 1

Group Standards of the People's Republic of China, Biopharmaceuticals 1

  • T/CAB 2009-2017 Production of antibiotic-free mutton sheep and mutton quality requirements
  • T/APEP 1024-2022 Discharge Standards for Water Pollutants in Bioengineering Pharmaceutical Industry
  • T/ZJPA 001-2021 Technical consideration of environmental microbial database construction in pharmaceutical industry
  • T/SHMHZQ 022-2022 Technical specification for the production of pharmaceutical tablets
  • T/CI 010-2021 Planting regulation and residue limit of harmful substances of Wild tending of genuine medicinal plants
  • T/ZZB 0668-2018 Sanitary mechanical seals for food and pharmaceutical industries
  • T/CACM 1374.1-2021 General rules of technical regulations for standardized production of traditional Chinese medicinal materials
  • T/JXYXH 0003-2022 Specification for material release of drug?manufacturing?enterprise
  • T/HFZX 005-2022 Code for green design of biomedical products
  • T/APEP 1026-2022 Discharge Standards for Water Pollutants of Traditional Chinese Medicine Pharmaceutical Industry
  • T/SDAHA 001-2023 Isatidis extract for veterinary preparations
  • T/SDVDA 002-2022 Honeysuckle extract for veterinary preparations
  • T/SDAHA 002-2023 Isatis root extract for veterinary preparations
  • T/CSF 003-2018 Operating procedures for aerial pesticide application to prevent and control pests
  • T/QME 0011-2023 Evaluation criteria for scientific and technological achievements in the bio-pharmaceutical field
  • T/SDAHA 004-2023 Maxine root extract for veterinary preparations
  • T/SDAHA 003-2023 Qingwen detoxification extract for veterinary preparations
  • T/SHDSGY 184-2023 Biomedical product design and brand management standards
  • T/NAHIEM 50-2022 Pollution-frees vector control
  • T/ZAII 019-2019 Specification for informatization integration of pharmaceutical production quality control
  • T/ZAII 018-2019 Function framework for integrated management and control of pharmaceutical production
  • T/CIQA 58-2023
  • T/CRES 0013-2022 Code for design of dark-photo combined biohydrogen production device using biomass
  • T/CSTE 0012-2020 Inorganic modified biodegradable material and product Part 1: Pellet
  • T/SDVDA 001-2022 Herba Artemisiae and Radix Isatidis extract for veterinary preparations
  • T/HTCMA 00002-2021 Standard for biodegradable plastic packaging bags for drug dispensing

工业和信息化部, Biopharmaceuticals 1

  • JB/T 20206-2022 Biopharmaceutical reaction process temperature control device
  • HG/T 5925-2021 Biological agent nitrifying agent for water treatment
  • HG/T 5926-2021 Biological agent denitrification agent for water treatment

Korean Agency for Technology and Standards (KATS), Biopharmaceuticals 1

  • KS J 0020-2010(2021) Production system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0022-2010(2021) Laboratory control system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0017-2010(2021) Quality system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0015-2010(2021) Quality manual in biopharmaceutical production based on current Good Manufacturing Practice
  • KS J 0018-2010(2021) Materials system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0021-2010(2021) Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS J 0016-2010(2021) Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS P ISO 11418-1:2020 Containers and accessories for pharmaceutical preparations —Part 1: Drop-dispensing glass bottles
  • KS J 0015-2010 Quality manual in biopharmaceutical production based on current Good Manufacturing Practice
  • KS J 0020-2010 Production system policy in biopharmaceutical production based on Good Manufacturing Practice
  • KS P ISO 8871-4:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 4：Biological requirements and test methods
  • KS I ISO 9509-2008(2018) Water quality－Method for assessing the inhibition of nitrification of activated sludge micro organisms by chemicals and wastewaters
  • KS H ISO 3890-1:2006 Milk and milk products－Determination of residues of organochlorine compounds(pesticides)－Part 1：General considerations and extraction methods

Professional Standard - Environmental Protection, Biopharmaceuticals 1

  • HJ 1256-2022 Technical guidelines for self-monitoring of pollutant discharge units
  • HJ 1062-2019 Pollutant Discharge Permit Application and Issuance Technical Specifications Pharmaceutical Industry-Biological Pharmaceutical Products Manufacturing

农业农村部, Biopharmaceuticals 1

  • NY/T 2888.1-2016 Fungal microbial pesticide Trichoderma Part 1: Trichoderma mother drug
  • NY/T 3282.1-2018 Fungal microbial pesticide Metarhizium anisopliae Part 1: Metarhizium anisopliae mother drug
  • NY/T 3278.1-2018 Guidelines for environmental value-added testing of microbial pesticides Part 1: Soil
  • NY/T 3273-2018 Guidelines for Aquatic Organism Toxicity Testing of Refractory Pesticides
  • NY/T 1464.76-2018 Guidelines for Pesticide Field Efficacy Tests Part 76: Plant Growth Regulators Promote Peanut Growth
  • NY/T 1464.62-2016 Guidelines for Pesticide Field Efficacy Tests Part 62: Plant Growth Regulators Promote Watermelon Growth
  • NY/T 3280.1-2018 Viral Microbial Pesticides: Helicoverpa armigera nuclear polyhedrosis virus Part 1: Mother drug of Helicoverpa armigera nuclear polyhedrosis virus
  • NY/T 3152.1-2017 Test Guidelines for Environmental Risk Assessment of Microbial Pesticides Part 1: Bird Toxicity Test
  • NY/T 3090-2017 Test Guidelines for Chemical Pesticide Duckweed Growth Inhibition

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Biopharmaceuticals 1

  • GB 21907-2008 Discharge standard of water pollutants for pharmaceutical industry Bio-pharmaceutical category
  • GB/T 31720-2015 Insecticide resistance management for vector.General rules
  • GB/T 15692.8-1995 Terms of pharmaceutical machinery--Medicine detecting instrument
  • GB/T 26347-2010 Test methods of mosquito resistance to insecticides.Bioassay methods
  • GB 28670-2012 General rule of pharmaceutical machinery conforming to good manufacturing practice
  • GB 18068.1-2012 Health protection zone for non-metallic mineral products industry.Part 1:Cement industry
  • GB/T 27623.1-2011 Pharmacodynamic test technical specification for aquaculture antimicrobial agent.Part 1:Antibiotics susceptibility test of macro-broth dilution method
  • GB 37823-2019 Discharge Standards of Pollutants for Pesiticides Manufacture -----Sulfonylurea Family
  • GB/T 26350-2010 Test methods of fly resistance to insecticides.The bioassay methods for musca domestica

Jiangsu Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB32/ 3560-2019 Discharge limits of water and air pollutants in the biopharmaceutical industry
  • DB32/T 4555-2023 Technical specifications for preparation and quality control of biochemical drugs of animal origin
  • DB32/T 2913.1-2016 Laboratory Springer Spaniels Part 1: Genetics, Microbiology, and Parasite Control
  • DB32/ 4042-2021 Emission Standards of Air Pollutants for the Pharmaceutical Industry

US-HHS, Biopharmaceuticals 1

US-FCR, Biopharmaceuticals 1

RU-GOST R, Biopharmaceuticals 1

  • GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
  • GOST 28085-2013 Medicine remedies biological for veterinary use. Method of bacteriological control of sterility
  • GOST R 57679-2017 Medicines for medical applications. Investigation bioequivalence of medications
  • GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
  • GOST R 55291-2012 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis
  • GOST 31928-2013 Probiotics medicine remedies for veterinary use. Methods for determination of the probiotics microorganisms
  • GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations
  • GOST 28083-2012 Biological medicinal remedies lyophilized for veterinary use. Method of control of vacuum in ampules and bottles
  • GOST R 57146-2016 Medicines for medical applications. Studying for carcinogenicity of pharmaceuticals and excipients
  • GOST R ISO 22030-2009 Soil quality. Biological methods. Chronic phytotoxicity for higher plants
  • GOST R 52896-2017 Manufacturing of medicinal product. Manufacturing systems and equipment for the production of medicines. General requirements
  • GOST R 57298-2016 Radiopharmaceutical medicinal products. General requirements for organization of production of radiopharmaceuticals in medical organizations
  • GOST R 57129-2016 Medicines for medical applications. Part 1. Stability testing of new drug substances and products. General

Professional Standard - Commodity Inspection, Biopharmaceuticals 1

  • SN/T 1750-2006 Determination of antibiotics residues in animal derived food-MIA method
  • SN/T 1751.1-2006 Determination of quiniline residues in animal derived food--Part 1 :MIA method
  • SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
  • SN/T 2127-2008 Determination of β-lactam residues in foodstuffs of animal origin for import and export.MIA method
  • SN/T 2423-2010 Determination of thiamphenicol and florfenicol residues in animal derived food-MIA method
  • SN/T 0005-1996 General rules for drafting the standards of biological method for the deternination of pesticide,veterinary drug residues and biotoxins in commodities for export
  • SN/T 2552.1-2010 Microbiological examination method for milk and milk products hygiene.Part 1:Guidance on sampling
  • SN/T 2552.1-2018 Microbiological Examination Methods for Hygienic Microbiological Examination of Milk and Dairy Products for Export Part 1: Sampling Guidelines
  • SN/T 2374-2009 Protocol of inspection for biopesticides of Metarhizium and Beauveria
  • SN/T 2355-2009 General rules for the storage of commonly used drugs for sanitary treatment at frontier ports

Beijing Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB11/T 1764.9-2022 Water Quotas Part 9: Chemicals and Biological Products
  • DB11/T 1821-2021 Technical Guidelines for Environmental Impact Assessment of Construction Projects Manufacturing of Biopharmaceutical Products
  • DB11/T 675-2009 Cleaner Production Standards Processing of Chinese Herbal Pieces and Manufacturing of Chinese Patent Medicines
  • DB11/T 675-2014 Cleaner Production Evaluation Index System Pharmaceutical Manufacturing Industry

Professional Standard - Agriculture, Biopharmaceuticals 1

HU-MSZT, Biopharmaceuticals 1

Hubei Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB42/T 2083.1-2023 Technical Regulations for Biological Control of Main Pests and Diseases of Traditional Chinese Medicinal Plants Part 1: Coptis Rhizome

Shanxi Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB14/T 2548-2022 Quality Control Bioassay Laboratory Management Specifications for Pharmaceutical Enterprises

German Institute for Standardization, Biopharmaceuticals 1

  • DIN 26055-1:2010 Hose assemblies for use in the pharmaceutical and biotechnological industry with hoses of non-metallic materials - Part 1: Hoses made of PTFE and derivatives
  • DIN 58940-1:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
  • DIN EN 17702-1:2023 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling; German and English version prEN 17702-1:2023
  • DIN EN 17702-1:2023-04 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling; German and English version prEN 17702-1:2023 / Note: Date of issue 2023-03-17*Intended as replacement for DIN CEN/TS 17702-1 (2022-07).
  • DIN EN 17708:2023-05 Plant biostimulants - Preparation of sample for microbial analysis; German and English version prEN 17708:2023 / Note: Date of issue 2023-03-31*Intended as replacement for DIN CEN/TS 17708 (2022-07).
  • DIN CEN/TS 17708:2022-07 Plant biostimulants - Preparation of sample for microbial analysis; German version CEN/TS 17708:2022
  • DIN CEN/TS 17702-1:2022-07 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling; German version CEN/TS 17702-1:2022
  • DIN EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09
  • DIN EN ISO 6887-1/A1:2023-08 Microbiology of the food chain - Preparation of test samples, initial suspension and decimal dilutions for microbiological examination - Part 1: General rules for the preparation of the initial suspension and decimal dilutions - Amendment 1: Requiremen...
  • DIN EN ISO 6887-1:2017 Microbiology of the food chain - Preparation of test samples, initial suspension and decimal dilutions for microbiological examination - Part 1: General rules for the preparation of the initial suspension and decimal dilutions (ISO 6887-1:2017)
  • DIN EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English

CU-NC, Biopharmaceuticals 1

British Standards Institution (BSI), Biopharmaceuticals 1

  • BS EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods
  • 23/30463072 DC BS EN 17702-1. Plant biostimulants. Sampling and sample preparation - Part 1. Sampling
  • PD CEN/TS 17708:2022 Plant biostimulants. Preparation of sample for microbial analysis
  • BS ISO 19617:2018 Traditional Chinese medicine. General requirements for the manufacturing process of natural products
  • BS EN 12689:1998 Biotechnology - Guidance on assessment of the purity, biological activity and stability of micro-organism based products
  • PAS 157:2015 Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide
  • BS DD ISO/TS 22224:2009 Health informatics - Electronic reporting of adverse drug reactions
  • 21/30423827 DC BS EN 13631-1. Explosives for civil uses. Explosives - Part 1. Requirements

Association Francaise de Normalisation, Biopharmaceuticals 1

  • NF U43-215:1981 Agropharmaceutical products. Petroleum oils for the manufacture of agropharmaceutical products. Distillation.
  • NF U43-214:1990 Agropharmaceutical products. Heavy oils for the manufacture of agropharmaceutical products. Specifications.
  • NF X34-122/A1*NF EN ISO 14780/A1:2019 Solid biofuels - Sample preparation - Amendment 1
  • NF EN ISO 14780/A1:2019 Biocombustibles solides - Préparation des échantillons - Amendement 1
  • NF U43-216:1981 Agropharmaceutical products. Petroleum oils for the manufacture of agropharmaceutical products. Determination of non-sulphonated residue.
  • XP CEN/TS 17702-1:2022 Biostimulants des végétaux - Echantillonnage et préparation des échantillons - Partie 1 : échantillonnage
  • NF U43-015:1973 Phytopharmaceutical products. Metaldehyde for industrial use. Requirements.
  • XP U45-026*XP CEN/TS 17708:2022 Plant biostimulants - Preparation of sample for microbial analysis
  • NF X42-050:1988 BIOTECHNOLOGY. GUIDE OF GOOD PRACTICES FOR THE INDUSTRIAL PRODUCTION OF CHEMICALS FROM A CLASS A "GILSP" MICROORGANISM.
  • NF U43-001:1973 Phytopharmaceutical products. Lime for sulphating compounds. Requirements.
  • NF S93-102-1*NF EN ISO 8871-1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1 : Extractables in aqueous autoclavates
  • NF X42-312*NF EN 12689:1998 Biotechnology. Guidance on assessment of the purity, biological activity and stability of microorganism based products.
  • NF S93-102-4*NF EN ISO 8871-4:2006 Elastomeric parts for parenteral and for devices for pharmaceutical use - Part 4 : biological requirements and test methods

CZ-CSN, Biopharmaceuticals 1

  • CSN ON 65 5758-1966 Biological Testing of Pesticides. Determination of Biological Activity oí Seed Dressings.
  • CSN ON 65 5759-1966 Biological Testing of Pesticides. Determination of Aparicidal Actrvity of Pesticidal Sprays.
  • CSN ON 65 5755-1966 Biological Testing of Pesticides. Phytotoxicity Determination of Fungicides
  • CSN ON 65 5760-1966 Biological Testing of Pesticides. Determination of Activity of Insecticidal Sprays.

US-CFR-file, Biopharmaceuticals 1

  • CFR 21-600.2-2013 Food and Drugs. Part600:Biological products: general. Section600.2:Mailing addresses.
  • CFR 21-558.415-2014 Food and drugs. Part558:New animal drugs for use in animal feeds. Section558.415:Novobiocin.
  • CFR 21-600.90-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.90:Waivers.
  • CFR 21-520.622b-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.622b:Diethylcarbamazine citrate syrup.
  • CFR 21-600.2-2014 Food and drugs. Part600:Biological products:general. SubpartA:General provisions. Section600.2:Mailing addresses.
  • CFR 21-600.81-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.81:Distribution reports.
  • CFR 21-526.1590-2014 Food and drugs. Part526:Intramammary dosage form new animal drugs. Section526.1590:Novobiocin infusion.
  • CFR 21-558.430-2014 Food and drugs. Part558:New animal drugs for use in animal feeds. Section558.430:Nystatin.
  • CFR 21-106.55-2014 Food and Drugs. Part106:Infant formula quality control procedures (Eff. until 7-10-14). Section106.55:Controls to prevent adulteration from microorganisms.
  • CFR 21-1301.75-2014 Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.75:Physical security controls for practitioners.
  • CFR 21-600.80-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.80:Postmarketing reporting of adverse experiences.
  • CFR 21-1301.74-2014 Food and drugs. Part1301:Registration of manufacturers, distributors, and dispensers of controlled substances. Section1301.74:Other security controls for nonpractitioners; narcotic treatment programs and compounders for narcotic treatment programs.
  • CFR 21-316.22-2013 Food and drugs. Part316:Orphan drugs. Section316.22:Permanent-resident agent for foreign sponsor.

YU-JUS, Biopharmaceuticals 1

VN-TCVN, Biopharmaceuticals 1

  • TCVN 7304-1-2003 Biological preparation.Part 1: Microorganism for water closet treatment.Powder

国家质量监督检验检疫总局, Biopharmaceuticals 1

  • SN/T 4747.2-2017 Microbial inhibition method for determination of macrolide drug residues in imported and exported food animals
  • SN/T 4458-2016 Microbiological testing of exported Chinese medicinal materials

Hebei Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB13/T 5363-2021 Technical Guidelines for the Control of Volatile Organic Compounds and Odor Gas Pollution in Biological and Chemical Pharmaceutical Industries

Professional Standard - Machinery, Biopharmaceuticals 1

  • JB 20031-2004 Ultra-pure pyrogen-free steam generator
  • JB 20067-2005 General rule of pharmaceutical machinery conform to good manufacturing practice

Gansu Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB62/T 2572-2015 Clean production Chinese herbal medicine processing and Chinese patent medicine manufacturing

Yunnan Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB5308/T 40-2017 Evaluation Standards for Green Biopharmaceutical Enterprises
  • DB5301/T 52-2021 Discharge limits of water pollutants in traditional Chinese medicine pharmaceutical industry

International Organization for Standardization (ISO), Biopharmaceuticals 1

  • ISO 14780:2017/Amd 1:2019 Solid biofuels — Sample preparation — Amendment 1
  • ISO 22467:2021 Traditional Chinese medicine — Determination of microorganisms in natural products
  • ISO 24088-1:2022 Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea
  • ISO/CD 18209-1 Biotechnology — Biobanking of parasites — Part 1: Helminths
  • ISO/DIS 18209-1:2023 Biotechnology — Biobanking of parasites — Part 1: Helminths
  • ISO 19617:2018 Traditional Chinese medicine — General requirements for the manufacturing process of natural products
  • ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
  • ISO 14780:2017 Solid biofuels - Sample preparation
  • ISO 14698-2:2003/cor 1:2004 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data; Technical Corrigendum 1
  • ISO 3890-1:2009|IDF 75-1:2009 Milk and milk products — Determination of residues of organochlorine compounds (pesticides) — Part 1: General considerations and extraction methods
  • ISO 3890-1:2009 Milk and milk products - Determination of residues of organochlorine compounds (pesticides) - Part 1: General considerations and extraction methods
  • ISO 23191:2020 Traditional Chinese medicine — Determination of selected Aconitum alkaloids by high-performance liquid chromatography (HPLC)
  • ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

ES-UNE, Biopharmaceuticals 1

  • UNE-EN ISO 14780:2018/A1:2020 Solid biofuels - Sample preparation - Amendment 1 (ISO 14780:2017/Amd 1:2019)
  • UNE-CEN/TS 17702-1:2022 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling (Endorsed by Asociación Española de Normalización in May of 2022.)
  • UNE-CEN/TS 17708:2022 Plant biostimulants - Preparation of sample for microbial analysis (Endorsed by Asociación Española de Normalización in May of 2022.)

Guangdong Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB44/T 1652.1-2015 Code of Practice for Vector Prevention and Control Part 1: Rodent Control

Danish Standards Foundation, Biopharmaceuticals 1

  • DS/ISO 11418-1:2005 Containers and accessories for pharmaceutical preparations - Part 1: Drop-dispensing glass bottles
  • DS/CEN/TS 16178:2012 Sludge, treated biowaste and soil - Determination of pharmaceutical products
  • DS/ISO 11418-4:2005 Containers and accessories for pharmaceutical preparations - Part 4: Tablet glass bottles

GOSTR, Biopharmaceuticals 1

  • GOST R ISO 11418-1-2017 Containers and accessories for pharmaceutical preparations. Part 1. Drop-dispensing glass bottles
  • GOST R 57645-2017 Microbiological products. Insecticide plant pathogenic fungus medication. Specifications
  • GOST R ISO 11418-4-2017 Containers and accessories for pharmaceutical preparations. Part 4. Tablet glass bottles

KR-KS, Biopharmaceuticals 1

  • KS P ISO 11418-1-2020 Containers and accessories for pharmaceutical preparations —Part 1: Drop-dispensing glass bottles

Professional Standard - Chemical Industry, Biopharmaceuticals 1

中华人民共和国环境保护部, Biopharmaceuticals 1

  • GB 21906-2008 Discharge standard of water pollutants for pharmaceutical industry Chinese traditional medicine category

US-COE, Biopharmaceuticals 1

Professional Standard - Medicine, Biopharmaceuticals 1

  • YY/T 0188.6-1995 Operating methods for the tests and assays of drugs.Part 6:Biological assays of drugs

US-DOT, Biopharmaceuticals 1

GB-REG, Biopharmaceuticals 1

European Committee for Standardization (CEN), Biopharmaceuticals 1

  • EN 14780:2011 Solid biofuels - Sample preparation
  • FprCEN/TS 17702-1-2021 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling
  • prEN 17702-1 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling
  • CEN/TS 17702-1:2022 Plant biostimulants - Sampling and sample preparation - Part 1: Sampling
  • FprCEN/TS 17708-2021 Plant biostimulants - Preparation of sample for microbial analysis
  • EN ISO 17516:2014 Cosmetics - Microbiology - Microbiological limits
  • EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
  • EN ISO 6887-1:2017 Microbiology of the food chain - Preparation of test samples@ initial suspension and decimal dilutions for microbiological examination - Part 1: General rules for the preparation of the initial suspension and decimal dilutions
  • prEN 374-1-1992 Protective gloves against chemicals and micro-organisms; part 1: terminology and performance requirements
  • EN 12689:1998 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
  • EN ISO 6887-1:1999 Microbiology of Food and Animal Feeding Stuffs - Preparation of Test Samples, Initial Suspension and Decimal Dilutions for Microbiological Examination - Part 1: General Rules for the Preparation of the Initial Suspension and Decimal Dilutions ISO 6887-1:
  • EN ISO 14698-1:2003 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods ISO 14698-1:2003

Professional Standard - Petrochemical Industry, Biopharmaceuticals 1

U.S. Environmental Protection Agency (U.S. EPA), Biopharmaceuticals 1

AT-ON, Biopharmaceuticals 1

国家发展和改革委员会, Biopharmaceuticals 1

  • JB/T 20067-2005 Pharmaceutical machinery complies with the General Principles of Good Manufacturing Practice for Pharmaceutical Products

ZA-SANS, Biopharmaceuticals 1

  • SANS 5550:2009 Potency of antibiotics - Microbiological agar diffusion method of assay (two-point technique)
  • SANS 192:1978 Pesticides: Biological evaluation of the efficacy of molluscicides

Professional Standard - Military and Civilian Products, Biopharmaceuticals 1

  • WJ 2655.1-2005 Appraisement of security at the powder and explosive produces for weapon profession.Part 1: Rule

Japanese Industrial Standards Committee (JISC), Biopharmaceuticals 1

Sichuan Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB51/T 1663-2013 Technical regulations for biological identification of pesticide residues in mulberry leaves

Jilin Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB22/T 1862-2013 Hygienic protection norms for the application of antineoplastic drugs

未注明发布机构, Biopharmaceuticals 1

  • BS 3221-1:1985(2011) Medicine measures — Part 1 : Specification for medicine measures of 50 mL total graduated capacity

Association of German Mechanical Engineers, Biopharmaceuticals 1

  • VDI 4255 Blatt 1-2005 Bioaerosols and biological agents - Sources of emissions and control measures - Overview
  • VDI 4255 Blatt 1 Berichtigung-2016 Bioaerosols and biological agents - Sources of emissions and control measures - Overview - Corrigendum concerning standard VDI 4255 Part 1:2005-10
  • VDI 4255 Blatt 2-2009 Bioaerosols and biological agents - Emission sources and control measures in livestock operations - Overview

RO-ASRO, Biopharmaceuticals 1

Standard Association of Australia （SAA）, Biopharmaceuticals 1

  • AS 1807:2021 Separative devices — Biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators — Methods of test

Liaoning Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB21/T 2521-2015 Chemical Synthesis Pharmaceutical Safety Production Technical Regulations

Guangxi Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

Professional Standard - Hygiene , Biopharmaceuticals 1

  • WS/T 248-2005 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria

中华人民共和国卫生部、中国国家标准化管理委员会, Biopharmaceuticals 1

  • GB/T 18068.1-2012 Health protection zone for non-metallic mineral products industry - Part 1：Cement industry

Henan Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

Taiwan Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • CNS 14384-3-1999 Protective gloces against chemicals and micro-organisms - Part 3:Determination of resistance to permeation by chemicals
  • CNS 14384.3-1999 Protective gloces against chemicals and micro-organisms - Part 3:Determination of resistance to permeation by chemicals

Shandong Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB37/T 2602.1-2014 Technical Regulations for the Production of Chinese Medicinal Materials Part 1: Sophora flavescens

CEN - European Committee for Standardization, Biopharmaceuticals 1

International Dairy Federation (IDF), Biopharmaceuticals 1

  • IDF 75-1-2009 Milk and milk products - Determination of residues of organochlorine compounds (pesticides) - Part 1: General considerations and extraction methods

AENOR, Biopharmaceuticals 1

  • UNE-EN ISO 6887-1:2017 Microbiology of the food chain - Preparation of test samples, initial suspension and decimal dilutions for microbiological examination - Part 1: General rules for the preparation of the initial suspension and decimal dilutions (ISO 6887-1:2017)

Anhui Provincial Standard of the People's Republic of China, Biopharmaceuticals 1

  • DB34/ 310005-2021 Emission Standards of Air Pollutants for the Pharmaceutical Industry

Compressed Gas Association (U.S.), Biopharmaceuticals 1

  • CGA M-2-2013 GENERAL GUIDE FOR THE MANUFACTURE OF MEDICAL GASES CLASSIFIED AS DRUGS

National Metrological Technical Specifications of the People's Republic of China, Biopharmaceuticals 1

American National Standards Institute （ANSI), Biopharmaceuticals 1

IT-UNI, Biopharmaceuticals 1

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