Document Center List of Standards on Pharmaceutics In General
ICS Code 11.120.01
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-E1073 - Standard Test Method for Obtaining a Pharmacological Profile with Mice (Withdrawn 2010)
- ASTM-E1302 - Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
- ASTM-E1391 - Standard Guide for Collection, Storage, Characterization, and Manipulation of Sediments for Toxicological Testing and for Selection of Samplers Used to Collect Benthic Invertebrates
- ASTM-E1483 - Standard Test Method for Assessing Developmental Toxicity in Rats and Rabbits (Withdrawn 2010)
- ASTM-E2363 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
- ASTM-E2474 - Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
- ASTM-E2475 - Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
- ASTM-E2537 - Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
- ASTM-E2891 - Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
- ASTM-E2968 - Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
- ASTM-F619 - Standard Practice for Extraction of Medical Plastics
- ASTM-F624 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
- ASTM-F639 - Standard Specification for Polyethylene Plastics for Medical Applications
- ASTM-F640 - Standard Test Methods for Determining Radiopacity for Medical Use
- ASTM-F702 - Standard Specification for Polysulfone Resin for Medical Applications
- ASTM-F997 - Standard Specification for Polycarbonate Resin for Medical Applications
BSI:
- BIP-3083 - Graphical symbols for use in the labelling of medical devices CD-ROM
- BS-EN-1041 - Information supplied by the manufacturer of medical devices
- BS-EN-12442-1 - Animal tissues and their derivatives utilized in the manufacture of medical devices. Analysis and management of risk
- BS-EN-12442-2 - Animal tissues and their derivatives utilized in the manufacture of medical devices
- BS-EN-12442-3 - Part 3: Validation of the Elimination &/or Inactivation of Viruses & Transmissible Agents,
- BS-EN-14375 - Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing
- BS-EN-30993-3 - Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
- BS-EN-980 - Symbols for use in the labelling of medical devices
- BS-ISO-20417 - Medical devices. Information to be supplied by the manufacturer
Other SDOs:
- DIN-EN-14375 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing; German version EN 14375:2016
- DIN-EN-980 - Symbols for use in the labelling of medical devices; German version EN 980:2008
- DIN-EN-ISO-14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- EN-1041 - Information supplied by the manufacturer of medical devices
- EN-14375 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
- EN-15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
- EN-980 - Symbols for use in the labelling of medical devices - Replaced by EN-ISO-15223-1
- SIS-CEN/CLC/TR-14060 - Medical device traceability enabled by unique device identification (UDI)
- SIS-CEN-ISO/TR-20416 - Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
- SIS-CEN-ISO/TR-24971 - Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
- SIS-EN-ISO-15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
- SS-EN-1041 - Information supplied by the manufacturer of medical devices
- SS-EN-12442-1 - Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk
- SS-EN-12442-2 - Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling
- SS-EN-12442-3 - Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents
- SS-EN-14375 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
- SS-EN-15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
- SS-EN-1895 - Adhesives for paper and board, packaging and disposable sanitary products - 180° - "T" peel test for a flexible-to-flexible assembly
- SS-EN-980 - Symbols for use in the labelling of medical devices
- SS-EN-ISO-11138-7 - Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
- SS-EN-ISO-13408-1 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
- SS-EN-ISO-13408-2 - Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
- SS-EN-ISO-13408-3 - Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
- SS-EN-ISO-13408-4 - Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
- SS-EN-ISO-13408-5 - Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
- SS-EN-ISO-13408-6 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
- SS-EN-ISO-14161 - Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results (ISO 14161:2009)
- SS-EN-ISO-14375 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
- SS-EN-ISO-14730 - Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
- SS-EN-ISO-15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
- SS-EN-ISO-15225 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
- UNE-EN-ISO-15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- UNE-EN-ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- UNE-EN-ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling