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prEN ISO 11607-3 Public enquiry
Comment end date 2025-11-11
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies. This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring. This document applies to both preformed sterile barrier systems and sterile barrier systems. This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management. This document is intended to be used prior to process validation. NOTE ISO 11607-2 provides requirements for process specification and process validation.

EN ISO 11608-3:2022/prA1:2025 Public enquiry
Comment end date 2025-10-28
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/DAmd1:2025)
prEN 1865-1 Public enquiry
Comment end date 2025-10-21
Patient handling equipment used in ambulances - Part 1: General stretcher systems and patient handling equipment

This document specifies minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.

prEN ISO 5364 Public enquiry
Comment end date 2025-10-16
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO/DIS 5364:2025)

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.

prEN ISO 28399 Public enquiry
Comment end date 2025-10-16
Dentistry - External tooth bleaching products (ISO/DIS 28399:2025)

This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer's instructions for use. This document is not applicable to tooth bleaching products: — specified in ISO 11609; — intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; — auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This document does not specify biological safety aspects of tooth bleaching products. NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.

EN ISO 5361:2023/prA1 Public enquiry
Comment end date 2025-10-14
Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (ISO 5361:2023/DAM 1:2025)
EN ISO 10079-1:2022/prA1:2025 Public enquiry
Comment end date 2025-10-14
Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Ingress of water (ISO 10079-1:2022/DAmd1:2025)
prEN ISO 21611 Public enquiry
Comment end date 2025-10-14
Dentistry - Vocabulary for Source Conclusion for Human Identification by Dental Evidence (ISO/DIS 21611:2025)

This document is intended for forensic reporting on human identification by dental evidence.

EN ISO 11608-1:2022/prA1:2025 Public enquiry
Comment end date 2025-10-07
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/DAmd1:2025)
prEN ISO 11140-3 Public enquiry
Comment end date 2025-10-07
Sterilization of health care products - Chemical indicators - Part 3: Type 2 indicators for use in the Bowie and Dick-type steam penetration test (ISO/DIS 11140-3:2025)

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

prEN ISO 11140-4 Public enquiry
Comment end date 2025-10-07
Sterilization of health care products - Chemical indicators - Part 4: Type 2 indicator systems as an alternative to the Bowie and Dick-type test for the detection of steam penetration (ISO/DIS 11140-4:2025)

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

prEN IEC 63483:2025 Public enquiry
Comment end date 2025-10-01
Methods for spectral imaging performance evaluation of computed tomography
prEN ISO 8637-2 Public enquiry
Comment end date 2025-09-16
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637‑2:2025)

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: —     haemodialysers, haemodiafilters or haemofilters; —     plasmafilters; —     haemoperfusion devices; —     vascular access devices. NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

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Technical Committee
TK 1 Electronics (10) TK 4 Information technology (4) TK 5 Electrical engineering (8) TK 8 Electromagnetic compatibility (2) TK 9 Furniture (1) TK 13 Agricultural engineering (2) TK 15 Cereals, cereal products, bread and animal feeding stuffs (1) TK 18 Telecommunications (4) TK 19 Concrete and reinforced concrete (1) TK 20 Toys, child use articles, sports and other recreational equipment (3) TK 21 Textiles and personal protective equipment (5) TK 22 Fire safety (3) TK 24 Quality management and quality assurance (3) TK 26 Thermal insulation materials (1) TK 29 Water supply (9) TK 31 Acoustics (1) TK 32 Health (13) TK 33 Fishery (1) TK 35 Safety of machinery (7) TK 36 Environmental protection (9) TK 38 Building constructions (1) TK 39 Protection (2) TK 40 Petroleuml, petroleum products, lubricants and alternative fuels (1) TK 42 Packaging (3) TK 43 Railway traffic (11) TK 45 Electric power (6) TK 50 Heating and Ventilation Systems (1) TK 56 Equipment for petroleum industry (5) TK 57 Fertilizers (2) TK 58 Refractory products and materials (dormant) (3) TK 65 Tourism services (1) TK 66 Non-destructive testing (2) TK 68 Plastics (2) TK 76 Explosive atmospheres (5) TK 77 Lifts (5) TK 79 IT security techniques (2) TK 80 Road transport and traffic telematics (2) TK 82 Safety of trackless overground vehicles (3) TK 86 Geographic information (2) TK 87 Biotechnology (3) TK 91 Asset management and technical maintenance (1) TK 98 Digital Product Passport (DPP) (8) TK 99 Health Informatics (2)
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Kiti su dirvožemio kokybe susiję standartai (1) Biologinės dirvožemio savybės (1) Accident and disaster control (1) Acoustic measurements and noise abatement in general (1) Advanced ceramics (1) Aerospace electric equipment and systems (2) Alarm and warning systems (1) Alkaline secondary cells and batteries (1) Anaesthetic, respiratory and reanimation equipment (2) Biology. Botany. Zoology (3) Boilers and heat exchangers (1) Bolts, screws, studs (3) Bottles. Pots. Jars (1) Buildings in general (1) Cabled distribution systems (1) Cables (1) Cableway equipment (1) Cereals, pulses and derived products (1) Chemical laboratories. Laboratory equipment (1) Chemicals for purification of water (8) Chimneys, shafts, ducts (1) Cleaning appliances (1) Company organization and management in general (1) Concrete and concrete products (3) Cranes (1) Cycles (1) Diagnostic, maintenance and test equipment (1) Disinfectants and antiseptics (1) Domestic safety (1) Earth-moving machinery (4) Electric furnaces (1) Electric road vehicles (2) Electrical and electronic equipment (2) Electrical and electronic testing (2) Electrical apparatus for explosive atmospheres (2) Electrical engineering in general (1) Electronic component assemblies (1) Emission (2) Environmental economics. Sustainability (5) Equipment for children (1) Equipment for the metallurgical industry (1) Explosion protection (1) Fasteners in general (1) Fibre optic interconnecting devices (2) Fibres and cables (3) Fire protection (1) Fire-fighting (1) Fire-resistance of building materials and elements (1) First aid (1) Fishing and fish breeding (1) Furniture (1) Gas heaters (2) Heat pumps (3) Indoor sports equipment (1) Information technology (IT) in general (2) Irons (1) IT applications in education (1) IT applications in health care technology (1) IT applications in industry (1) IT applications in science (1) IT applications in trade (4) IT applications in transport (2) IT Security (1) Items of art and handicrafts. Cultural property and heritage (1) Lifts. Escalators (1) Luminaires (1) Management systems (1) Materials and components for railway engineering (1) Mechanical structures for electronic equipment (2) Metro, tram and light rail equipment (1) Multimedia systems and teleconferencing equipment (1) Non-destructive testing of metals (2) Other cells and batteries (5) Other fibre optic equipment (1) Other rubber and plastics products (1) Outdoor and water sports equipment (1) Petroleum products and natural gas handling equipment (1) Piezoelectric devices (1) Pipelines and its parts for external sewage systems (1) Pressure regulators (1) Printed circuits and boards (1) Product and company certification. Conformity assessment (1) Protection against falling and slipping (1) Protective clothing (2) Radiation measurements (2) Radiation protection (1) Radiographic equipment (1) Railway engineering in general (4) Railway rolling stock in general (2) Rectifiers. Converters. Stabilized power supply (2) Refractories (3) Refrigerating technology (1) RF connectors (1) Safety of machinery (1) Small craft (1) Small kitchen appliances (1) Solar energy engineering (2) Special wastes (1) Sports facilities (1) Stationary containers and tanks (1) Superconductivity and conducting materials (1) Syringes, needles and catheters (2) Technical product documentation (1) TELECOMMUNICATIONS. AUDIO AND VIDEO ENGINEERING (4) Textile auxiliary materials (1) Theatre, stage and studio equipment (1) Thermal and sound insulating materials (1) Trailing stock (1) Valves in general (2)