GDPR

projektai-lsd Lithuanian Standards Board
Portal for draft standards

Extended search

till

Results

Showing:
ISO/DIS 23494-1 Public enquiry
Comment end date 2025-09-16
Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements

This document specifies a general concept for provenance information of biological material and data, organizational roles, and requirements for provenance information management. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: a) acquiring, collecting, processing, testing, analyzing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); b) generating, collecting, analyzing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); c) generating, collecting, analyzing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain). d) Manufacturing devices or software for the afore mentioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). Customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can use this document in confirming or recognizing the competence of the aforementioned parties. This document does not apply to biological material and data used for medical diagnosis, treatment and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

ISO/DIS 23494-2 Public enquiry
Comment end date 2025-09-15
Biotechnology — Provenance information model for biological material and data — Part 2: Common Provenance Model

This document specifies a common model for generating, maintaining, and provisioning provenance information on objects, such as biological material and data. This document also specifies requirements for provenance information serialization to achieve its interoperability. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: a) acquiring, collecting, processing, testing, analyzing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); b) generating, collecting, analyzing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); c) generating, collecting, analyzing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain). d) Manufacturing devices or software for the afore mentioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). Customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can use this document in confirming or recognizing the competence of the aforementioned parties. This document does not apply to biological material and data used for medical diagnosis and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Quick filters

Technical Committee
TK 1 Electronics (12) TK 4 Information technology (1) TK 5 Electrical engineering (10) TK 6 Fruit and vegetables products (4) TK 9 Furniture (1) TK 12 Motor - roads (2) TK 18 Telecommunications (5) TK 20 Toys, child use articles, sports and other recreational equipment (5) TK 21 Textiles and personal protective equipment (15) TK 22 Fire safety (6) TK 28 Gas systems (8) TK 29 Water supply (1) TK 31 Acoustics (4) TK 32 Health (6) TK 35 Safety of machinery (3) TK 36 Environmental protection (6) TK 39 Protection (4) TK 40 Petroleuml, petroleum products, lubricants and alternative fuels (3) TK 43 Railway traffic (12) TK 45 Electric power (7) TK 46 Roofs and building waterproof isolation (2) TK 47 Information and documentation (2) TK 49 Metallic materials (2) TK 50 Heating and Ventilation Systems (3) TK 51 Food analysis- Horizontal methods (6) TK 52 Ophthalmic optics and lasers (2) TK 54 Assistive products for persons with disability (1) TK 56 Equipment for petroleum industry (5) TK 57 Fertilizers (1) TK 60 Windows and doors (1) TK 63 Gas cylinders and cryogenic vessels (1) TK 64 Ergonomics (1) TK 66 Non-destructive testing (4) TK 68 Plastics (10) TK 71 Sustainably produced biomass for energy application, solid biofuel and solid recovered fuel (2) TK 76 Explosive atmospheres (7) TK 77 Lifts (4) TK 79 IT security techniques (1) TK 82 Safety of trackless overground vehicles (6) TK 84 Chimneys and solid fuel burning appliances (1) TK 86 Geographic information (1) TK 87 Biotechnology (2) TK 98 Digital Product Passport (DPP) (6)
ICS
Biologinės dirvožemio savybės (1) Vandenilio technologijos (3) Accident and disaster control (1) Acoustic measurements and noise abatement in general (2) Acoustics in building. Sound insulation (1) Additive manufacturing (1) Aerospace electric equipment and systems (3) Agricultural tractors and trailed vehicles (1) Alarm and warning systems (2) Aluminium products (1) Biobased products (2) Biofuels (2) Biology. Botany. Zoology (2) Bolts, screws, studs (4) Cableway equipment (2) Check valves (1) Coatings and related processes used in aerospace industry (1) Components for aerospace construction (1) Cranes (1) Domestic, commercial and industrial heating appliances (2) Ecolabelling (1) Electric furnaces (2) Electric tools (2) Electric traction equipment (2) Electrical and electronic equipment (3) Electrical apparatus for explosive atmospheres (3) Electromagnetic compatibility in general (1) Electronic component assemblies (1) Energy efficiency. Energy conservation in general (1) Environmental economics. Sustainability (4) Ergonomics (1) Explosion protection (1) Fibre optic interconnecting devices (5) Fibres and cables (2) Fire-fighting (3) Fire-resistance of building materials and elements (1) Floor coverings (1) Food microbiology (3) Furniture (1) Fuses and other overcurrent protection devices (1) Galvanic cells and batteries (1) Ground service and maintenance equipment (1) Hand-operated tools (1) Head protective equipment (2) Heat pumps (3) Ignitability and burning behaviour of materials and products (2) Incandescent lamps (1) Industrial trucks (1) Information sciences (1) Interface and interconnection equipment (1) Irons (1) IT applications in education (1) IT applications in industry (1) IT applications in trade (2) IT Security (2) Leather and furs (1) Lifts. Escalators (1) Liquid fuels (1) Liquid wastes. Sludge (1) Management systems (1) Mechanical structures for electronic equipment (2) Medical equipment in general (2) Metro, tram and light rail equipment (1) Non-destructive testing (3) Oilseeds (1) Optic amplifiers (1) Optoelectronics. Laser equipment (2) Other standards related to lamps (1) Outdoor and water sports equipment (2) Petroleum products and natural gas handling equipment (7) Pipelines and its parts for external sewage systems (1) Plastics in general (2) Powder metallurgy (1) Pressure regulators (1) Protection against falling and slipping (1) Protective clothing (8) Publishing (1) Railway engineering in general (1) Railway rolling stock in general (1) Rectifiers. Converters. Stabilized power supply (1) Refrigerating technology (1) Relays (1) RF connectors (2) Roofs (2) Rotating machinery in general (1) Sensory analysis (2) Solar energy engineering (3) Special purpose vehicles (4) Spices and condiments (4) Sports facilities (3) Springs (3) Steel pipes and tubes for specific use (1) Switches (1) TELECOMMUNICATIONS. AUDIO AND VIDEO ENGINEERING (5) Test conditions and procedures in general (2) Textile fabrics (1) Textiles in general (1) Theatre, stage and studio equipment (2) Therapy equipment (1) Thermal and sound insulating materials (1) Thermoplastic materials (1) Transfusion, infusion and injection equipment (1) Ventilation and air-conditioning systems (1) Walls. Partitions. Façades (1) Welded joints and welds (2) Welding equipment (1) Welding processes (1) Wires (2)