GDPR

projektai-lsd Lithuanian Standards Board
Portal for draft standards

Extended search

till

Results

Showing:
ISO/DIS 23565 Public enquiry
Comment end date 2026-07-31
Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cellular therapeutic products

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cellular therapeutic products. This includes equipment for processing cellular therapeutic products starting from cell isolation/selection, expansion, washing, volume reduction, final formulation and preparation prior to cryopreservation for storage of cellular therapeutic products. This document provides guidance on the design, use and maintenance of equipment and equipment systems to both equipment suppliers and equipment users including aspects such as the target parties, i.e. equipment supplier or equipment user, and the phase of the involved task, i.e. design, use, or maintenance. This document is applicable to any unit operation system, that is intended to be used, either alone or in combination, for the manufacture of cellular therapeutic products by meeting equipment user requirements. It is applicable to equipment used for the purpose of monitoring the equipment status. This document does not apply to: — processing equipment for cellular therapeutic products used at the point of care; — equipment used for analytical purposes; — biosafety cabinets, general cell culture equipment (such as CO2 incubators, etc.); — software to control multiple equipment systems or multiple unit operations.

Quick filters

Technical Committee
TK 1 Electronics (7) TK 4 Information technology (5) TK 5 Electrical engineering (43) TK 6 Fruit and vegetables products (1) TK 12 Motor - roads (3) TK 13 Agricultural engineering (6) TK 18 Telecommunications (13) TK 20 Toys, child use articles, sports and other recreational equipment (2) TK 21 Textiles and personal protective equipment (2) TK 22 Fire safety (3) TK 23 Ceramic tiles, masonry and natural stones (3) TK 28 Gas systems (2) TK 29 Water supply (2) TK 32 Health (10) TK 34 Metrology (2) TK 35 Safety of machinery (2) TK 36 Environmental protection (5) TK 38 Building constructions (27) TK 39 Protection (1) TK 40 Petroleuml, petroleum products, lubricants and alternative fuels (1) TK 41 Welding (6) TK 42 Packaging (2) TK 43 Railway traffic (3) TK 45 Electric power (12) TK 47 Information and documentation (1) TK 49 Metallic materials (4) TK 50 Heating and Ventilation Systems (1) TK 51 Food analysis- Horizontal methods (1) TK 52 Ophthalmic optics and lasers (2) TK 54 Assistive products for persons with disability (2) TK 57 Fertilizers (1) TK 59 Geotechnics (1) TK 60 Windows and doors (2) TK 63 Gas cylinders and cryogenic vessels (2) TK 65 Tourism services (1) TK 68 Plastics (3) TK 70 Pulp, paper, board, adhesives (5) TK 71 Sustainably produced biomass for energy application, solid biofuel and solid recovered fuel (1) TK 76 Explosive atmospheres (1) TK 77 Lifts (1) TK 79 IT security techniques (6) TK 80 Road transport and traffic telematics (2) TK 82 Safety of trackless overground vehicles (2) TK 86 Geographic information (1) TK 87 Biotechnology (1) TK 88 Building Information Modelling (BIM) (1) TK 89 Risk management and organizational governance (1) TK 91 Asset management and technical maintenance (1) TK 99 Health Informatics (2)
ICS
Biologinės dirvožemio savybės (1) Plonasis popierius (1) Advanced ceramics (3) Aircraft and space vehicles in general (2) Alarm and warning systems (1) Aluminium products (2) Application of information technology in general (2) Binders. Sealing materials (3) Biological evaluation of medical devices (1) Biology. Botany. Zoology (1) Bolts, screws, studs (1) Bridge construction (1) Building accessories (2) Cans. Tins. Tubes (2) Cement. Gypsum. Lime. Mortar (4) Chemical laboratories. Laboratory equipment (1) Cleaning appliances (1) Coatings and related processes used in aerospace industry (2) Company organization and management in general (1) Concrete and concrete products (1) Concrete structures (2) Cooking ranges, working tables, ovens and similar appliances (11) Dental instruments (1) Dental materials (2) Dishwashers (2) Domestic electrical appliances in general (3) Domestic refrigerating appliances (2) Domestic safety (10) Earth-moving machinery (1) Earthworks. Excavations. Foundation construction. Underground works (2) Electric heaters (2) Electric traction equipment (1) Electrical accessories in general (1) Electrical and electronic equipment (1) Electrical apparatus for explosive atmospheres (1) Electricity supply systems (1) Electronics (Vocabularies) (2) Emission (1) Environmental economics. Sustainability (1) Environmental impact assessment (1) Environmental testing (2) Equipment for children (2) Equipment for storage, preparation and distribution of fertilizers (1) Ergonomics (1) Exploratory, drilling and extraction equipment (1) Fibres and cables (2) Fire protection (1) Fire-resistance of building materials and elements (1) First aid (3) Fissile materials and nuclear fuel technology (4) Fixed capacitors (1) Flow in open channels (1) Gas cylinders (2) Gas supply systems (1) Generators (1) Health care services in general (1) Heat pumps (1) Identification cards. Chip cards. Biometrics (1) Immunity (2) Implants for surgery, prosthetics and orthotics (1) In vitro diagnostic test systems (2) Indoor sports equipment (1) Industrial robots. Manipulators (1) Industrial trucks (1) Insulating materials in general (3) IT applications in health care technology (2) IT applications in science (1) IT applications in transport (2) IT Security (8) Lamps in general (1) Leather and furs (1) Lifts. Escalators (1) Liquid fuels (1) Management of human resources (1) Masonry (1) Materials and components for railway engineering (1) Measurement of electrical and magnetic quantities (5) Mechanical testing of metals (2) Metallic coatings (1) Natural gas (2) Nuclear power plants. Safety (1) Nuts (4) Oilseeds (1) Other lifting equipment (1) Other medical equipment (1) Other semiconductor devices (1) Other standards related to aids for disabled and handicapped people (1) Paper and board (4) Passenger and cabin equipmen (1) Petroleum products and natural gas handling equipment (1) Pipeline components and pipelines in general (1) Pipelines and its parts for external sewage systems (1) Plastics in general (1) Plug-and-socket devices. Connectors (2) Pneumatic tools (1) Pollution, pollution control and conservation (1) Postal services (1) Power transmission and distribution lines (3) Protection against dangerous goods (1) Quantities and units (1) Radiation measurements (2) Radiation protection (1) Railway rolling stock in general (2) Rotating machinery in general (1) Seismic and vibration protection (1) Services in general (1) Small kitchen appliances (6) Solar energy engineering (1) Solid fuels (1) Spices and condiments (1) Stationary source emissions (1) Sterilization and disinfection in general (1) Surface treatment and coating in general (1) Technical aspects (17) TELECOMMUNICATIONS. AUDIO AND VIDEO ENGINEERING (13) Telecontrol. Telemetering (5) Therapy equipment (1) Timber structures (1) Transport by rail (1) Ventilation and air-conditioning systems (1) Walls. Partitions. Façades (1) Water heating equipment (1) Waxes, bituminous materials and other petroleum products (1) Welded joints and welds (3) Welding, brazing and soldering in general (1) Woodworking machines (2) Writing and transliteration (1)