product

SR EN 556-2:2025

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

Status : Valid
Language: English
product

SR EN 1865-6:2025

Patient handling equipment used in ambulances - Part 6: Powered chairs
This document specifies the minimum requirements for the design and performance of power assisted chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.

Status : Valid
Language: English
product

SR EN 455-1+A2:2025

Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

Status : Valid
Language: English
product

SR EN 12621:2025

Machinery for supply and circulation of liquid coating materials - Safety requirements
This document deals with all significant hazards, hazardous situations and events which are relevant to machinery for supply and circulation of liquid coating material, when used as intended and under the conditions foreseen by the manufacturer, including reasonably foreseeable misuse. See Annex A for significant hazards. Together with this document, EN 50050 1:2013, EN 50059:2025, EN 50176:2025 or EN 50348:2010 give requirements for electrostatic machinery for supply and circulation of liquid coating material. The specific significant risks related to the use of machinery for supply and circulation of liquid coating material with foodstuffs and pharmaceutical products are not dealt with in this document. Interfaces to connected machinery and systems are given in Figure 1, to specify the limit of the machinery for supply and circulation of liquid coating material. [Figure 1] Figure 1 - Limits of the machinery This document does not apply to: - pressure related hazards of equipment classified as higher than category 1 of Directive 2014/68/EU Article 13; NOTE 1 For equipment of higher

Status : Valid
Language: English
product

SR EN 556-1:2025

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.

Status : Valid
Language: English
product

SR EN 17184:2024

Intelligent transport systems — eSafety — eCall High level application protocols (HLAP) using IP Multimedia Subsystem (IMS) over packet switched networks
In respect of pan European eCall (operating requirements defined in EN 16072), this document defines the high level application protocols, procedures and processes required to provide the eCall service via a packet switched wireless communications network using IMS (IP Multimedia Subsystem) and wireless access (such as LTE, NR and their successors). This document assumes support of eCall using IMS over packet switched networks by an IVS and a PSAP and further assumes that all PLMNs available to an IVS at the time an eCall or test eCall is initiated are packet switched networks. Support of eCall where eCall using IMS over packet switched networks is not supported by an IVS or PSAP is out of scope of this document. At some moment in time packet switched networks will be the only Public Land Mobile Networks (PLMN) available. However as long as GSM/UMTS PLMNs are available (Teleservice 12/TS12) ETSI TS 122 003 will remain operational. Both the use of such PLMNs and the logic behind choosing the appropriate network in a hybrid situation (where both packet-switched and circuit-switched net

Status : Valid
Language: English
product

SR EN 1865-2:2024

Patient handling equipment used in ambulances - Part 2: Power assisted stretcher
This document specifies minimum requirements for the design and performance of power assisted stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.

Status : Valid
Language: English
product

SR EN 455-2:2024

Medical gloves for single use - Part 2: Requirements and testing for physical properties
This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Status : Valid
Language: English
product

SR EN 12312-4:2024

Aircraft ground support equipment - Specific requirements - Part 4: Passenger boarding bridges
This document specifies the technical requirements to minimize the hazards listed in Clause 4 which can arise during the commissioning, operation and maintenance of passenger boarding bridges (PBBs) when used as intended, including misuse reasonably foreseeable by the manufacturer, when carried out in accordance with the specifications given by the manufacturer or their authorized representative. It also takes into account some requirements recognized as essential by authorities, aircraft and ground support equipment (GSE) manufacturers as well as airlines and handling agencies. This document applies to: a) apron-drive bridges; b) fixed-head bridges (also referred to as nose-loaders) or pedestal bridges; c) suspended bridges for embarking/disembarking of passengers. It is applicable from the interface with the terminal building, which can be movable, e.g. on two levels to separate arrival and departure level to the connection with the aircraft including fixed tunnels. This document does not apply to: d) elevating lounges; e) passenger stairs; f) other form of aircraft access equipmen

Status : Valid
Language: English