ICS 11.120.01
Pharmaceutics in general
Standards in This Category
SM EN 1041+A1:2015
Information Provided by the Medical Device Manufacturer
This document establishes a framework for the provision of essential information by equipment manufacturers to end-users, ensuring clarity and safety in product usage. It specifies the requirements
SM SR EN 980:2010
Simboluri utilizate pentru etichetarea dispozitivelor medicale
This specification establishes a standardized set of graphical symbols designated for use on the labels of medical devices. These visual indicators serve to convey critical information regarding
SMV EN 980:2009
Simboluri utilizate pentru etichetarea dispozitivelor medicale
This document outlines a standardized set of graphical symbols specifically designed for use on medical device labeling. It establishes a consistent visual language to ensure that critical
MSZ EN 14375:2004
MSZT
Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing
This standard establishes comprehensive requirements and testing methodologies specifically designed for child-resistant packaging used in pharmaceutical products. It outlines precise criteria to
T/CNPPA 3033-2026
TUANTI
Technical requirement for ready to sterilize rubber closures
This document outlines the specialized technical requirements specifically designed for rubber seals intended for sterilization processes. It establishes precise criteria regarding material
T/CNPPA 3013-2026
TUANTI
Guidance for good manufacturing practice for pharmaceutical rubber closures
This technical specification establishes a comprehensive framework for managing production quality within the pharmaceutical rubber sealing component manufacturing sector. It provides detailed
T/CNPPA 3034-2026
TUANTI
Guidance of the performance testing for the transport packages of pharmaceutical products
This document establishes a comprehensive framework for evaluating the performance of pharmaceutical packaging during transportation. It outlines specific test methodologies designed to assess how
T/CNPPA 3015-2026
TUANTI
On-site audit guide for suppliers of pharmaceutical rubber seals
This document establishes a systematic framework for conducting on-site audits of suppliers providing rubber sealing components intended for pharmaceutical applications. The guidelines define
IRAM 9800-6:2023
IRAM
Good pharmacy practice. Medical devices dispensing management in health establishments.
IRAM 9801:2022
IRAM
Good pharmacy practice. Vocabulary
IRAM 37628:2021
IRAM
Medicinal plants. Peperina mint, Minthostachys verticillata (Griseb.) Epling - Lamiaceae and its comparison with Peperina chilena or False peperina mint, Clinopodium nepeta (L.) Kuntze – Lamiaceae.
IRAM 37631:2021
IRAM
Medicinal plants. Cáñamo, Cannabis sativa L. (Cannabaceae). Requirements.
IRAM 37638:2022
IRAM
Medicinal plants. Ambay, amb-ahú, amba’y, palo de lija, Cecropia pachystachya Trécul (Urticaceae). Requirements
IRAM 37637:2022
IRAM
Medicinal plants. Ginko, Ginko biloba L. (Ginkgoaceae). Requirements
MSZ EN 12442-2:2001
MSZT
Animal tissues and their derivatives utilized in the manufacture of medical devices. Part 2: Controls on sourcing, collection and handling
This document establishes specific regulatory requirements concerning the utilization of animal tissues and their derivatives within the context of medical device manufacturing. It focuses
MSZ EN 12442-1:2001
MSZT
Animal tissues and their derivatives utilized in the manufacture of medical devices. Part 1: Analysis and management of risk
This document establishes a comprehensive framework for managing risks associated with the use of animal-derived tissues and their derivatives in the manufacturing of medical devices. It focuses
MSZ EN 12442-3:2001
MSZT
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
This standard establishes a framework for validating the processes involved in removing and/or inactivating viruses and transmissible agents within animal-derived materials and their derivatives used
TZS 2797:2022
TBS
Sterilized sodium chloride intravenous infusion
TZS 2798:2022
TBS
Sterilized sodium chloride and dextrose intravenous infusion
TZS 2796:2022
TBS