GDPR

projektai-lsd Lithuanian Standards Board
Portal for draft standards

Extended search

till

Results

Showing:
EN IEC 60601-2-28:2019/prA1:2025 Public enquiry
Comment end date 2026-01-14
Amendment 1 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
EN ISO 13408-2:2018/prA1:2025 Public enquiry
Comment end date 2025-12-30
Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAmd1:2025)
ISO/DIS 24884 Public enquiry
Comment end date 2025-12-20
Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery
prEN ISO 8536-5 Public enquiry
Comment end date 2025-12-18
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO/DIS 8536-5:2025)

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

prEN IEC 63524:2025 Public enquiry
Comment end date 2025-12-10
Artificial Intelligence enabled Medical Devices - Computer assisted analysis software for pulmonary images - Algorithm performance test methods
prEN 18178-5 Public enquiry
Comment end date 2025-12-09
Respiratory infection prevention devices for self- and third-party protection - Part 5: Classification

This document specifies the classification for respiratory infection prevention devices (RIPDs). RIPDs are intended to reduce the emission of infective agents from the user’s airways into the environment, and also reduce exposure to the user from inhalation of infective agents. RIPDs are intended for use by everybody regardless of facial morphology or ability.

EN 455-3:2023/prA1 Public enquiry
Comment end date 2025-12-02
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

prEN ISO 21762 Public enquiry
Comment end date 2025-11-25
Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025)

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

EN ISO 4135:2022/prA1 Archived
Comment end date 2025-11-18
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2025)

Quick filters

Technical Committee
TK 1 Electronics (4) TK 4 Information technology (3) TK 5 Electrical engineering (11) TK 8 Electromagnetic compatibility (2) TK 12 Motor - roads (1) TK 13 Agricultural engineering (1) TK 15 Cereals, cereal products, bread and animal feeding stuffs (5) TK 17 Woods (6) TK 18 Telecommunications (1) TK 19 Concrete and reinforced concrete (4) TK 20 Toys, child use articles, sports and other recreational equipment (1) TK 21 Textiles and personal protective equipment (3) TK 23 Ceramic tiles, masonry and natural stones (1) TK 24 Quality management and quality assurance (2) TK 25 Matrix, gypsum and gypsum based products (2) TK 26 Thermal insulation materials (3) TK 29 Water supply (4) TK 32 Health (9) TK 33 Fishery (1) TK 35 Safety of machinery (7) TK 36 Environmental protection (2) TK 40 Petroleuml, petroleum products, lubricants and alternative fuels (2) TK 41 Welding (3) TK 42 Packaging (6) TK 43 Railway traffic (14) TK 45 Electric power (8) TK 49 Metallic materials (5) TK 50 Heating and Ventilation Systems (3) TK 51 Food analysis- Horizontal methods (3) TK 56 Equipment for petroleum industry (8) TK 57 Fertilizers (12) TK 59 Geotechnics (4) TK 60 Windows and doors (1) TK 65 Tourism services (2) TK 68 Plastics (2) TK 70 Pulp, paper, board, adhesives (5) 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 (1) TK 84 Chimneys and solid fuel burning appliances (1) TK 86 Geographic information (1) TK 87 Biotechnology (2) TK 88 Building Information Modelling (BIM) (1) TK 90 Human resource and knowledge management (1) TK 99 Health Informatics (2)
ICS
Cheminės dirvožemio charakteristikos (1) Acid secondary cells and batteries (1) Additive manufacturing (1) Adhesives (3) Aerospace electric equipment and systems (4) Agricultural tractors and trailed vehicles (1) Alarm and warning systems (1) Anaesthetic, respiratory and reanimation equipment (1) Audio, video and audiovisual systems in general (1) Biology. Botany. Zoology (3) Ceilings. Floors. Stairs (1) Cement. Gypsum. Lime. Mortar (2) Cereals, pulses and derived products (4) Chemical analysis of metals (1) Chemicals for purification of water (1) Chimneys, shafts, ducts (1) Cleanrooms and associated controlled environments (2) Concrete and concrete products (3) Concrete structures (1) Construction industry in general (1) Construction materials in general (2) Contractual aspects (1) Cooking ranges, working tables, ovens and similar appliances (1) Cookware, cutlery and flatware (2) Cranes (3) Diagnostic equipment (2) Domestic safety (2) Doors and windows (1) Earthworks. Excavations. Foundation construction. Underground works (2) Ecolabelling (1) Electric road vehicles (1) Electric traction equipment (1) Electrical apparatus for explosive atmospheres (1) Electrical engineering in general (1) Electroacoustics (1) Electromechanical components in general (1) Enamels (1) Examination of biological properties of water (1) Exploratory, drilling and extraction equipment (2) Explosives. Pyrotechnics and fireworks (1) External water conveyance systems (1) Fertilizers (10) Fibre optic interconnecting devices (4) Fibres and cables (1) Fixed resistors (2) Floor coverings (2) Fluid storage devices in general (2) Fluid systems and components for general use (Vocabularies) (1) Footwear (2) Gas and steam turbines. Steam engines (1) General methods of tests and analysis for food products (1) Geotextiles (1) Governance and ethics (1) Head protective equipment (2) Hoses and hose assemblies (2) Hospital equipment (1) Immunity (2) In vitro diagnostic test systems (1) Industrial process measurement and control (1) Industrial trucks (1) Iron and steel castings (1) Iron and steel products in general (1) IT applications in health care technology (2) IT applications in transport (2) IT Security (6) Leather and furs (2) Leg and foot protection (3) Liquid fuels (1) Low voltage switchgear and controlgear (2) Luminaires (1) Machine tools in general (1) Management of human resources (2) Management systems (2) Materials and components for railway engineering (1) Mechanical structures for electronic equipment (1) Mechanical testing of metals (3) Metallic coatings (1) Milk and processed milk products (1) Non-destructive testing of metals (1) Nuclear power plants. Safety (6) Oilseeds (1) On-board equipment and instruments (1) Optic amplifiers (1) Other buildings (1) Other graphical symbols (1) Other medical equipment (1) Other pipeline components (2) Other services (1) Outdoor and water sports equipment (1) Paper and board (2) Physicochemical methods of analysis (1) Physics. Chemistry (1) Pipelines and its parts for district heat (3) Pipes and fittings of other materials (1) Plastics and rubber insulating materials (1) Plastics fittings (1) Plastics in general (1) Plug-and-socket devices. Connectors (1) Product life-cycles (2) Protection against dangerous goods (1) Radiation measurements (1) Radiation protection (1) Rails and railway components (1) Railway rolling stock in general (4) Relays (1) Research and development (1) Road equipment and installations (1) Rotating machinery in general (3) Safety of machinery (1) Semiconductor devices in general (1) Small craft (1) Solar energy engineering (1) Sports facilities (1) Standardization. General rules (1) Sterilization and disinfection in general (1) Surface preparation (1) Technical product documentation (2) TELECOMMUNICATIONS. AUDIO AND VIDEO ENGINEERING (1) Textile fibres in general (1) Textiles in general (1) Thermal and sound insulating materials (1) Tractive stock (5) Transfusion, infusion and injection equipment (1) Volumetric equipment and measurements (1) Water supply systems (2) Welding equipment (1) Wood-protecting chemicals (5)