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 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 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 18031-3:2024

Common security requirements for radio equipment - Part 3: Internet connected radio equipment processing virtual money or monetary value
Common security requirements for internet connected radio equipment that equipment enables the holder or user to transfer money, monetary value or virtual currency. This document provides technical specifications for radio equipment processing virtual money or monetary value, which apply to electrical or electronic products that are capable to communicate over the internet, regardless of whether these products communicate directly or via any other equipment.

Status : Valid
Language: English
product

SR EN 18031-1:2024

Common security requirements for radio equipment - Part 1: Internet connected radio equipment
This document specifies common security requirements for internet-connected radio equipment. This document provides technical specifications for radio equipment, which concerns electrical or electronic products that are capable to communicate over the internet, regardless of whether these products communicate directly or via any other equipment.

Status : Valid
Language: English
product

SR EN 18031-2:2024

Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment
Common security requirements for radio equipment processing personal data or traffic data or location data being either internet connected radio equipment, radio equipment designed or intended exclusively for childcare; toys and wearable radio equipment. The standard provides technical specifications for radio equipment processing personal data, traffic data or location data, which concerns electrical or electronic products that are capable to communicate over the internet, regardless of whether these products communicate directly or via any other equipment, childcare, toys or wearable radio equipment. The scope does not apply to 5G network equipment used by providers of public electronic communications networks and publicly available electronic communications services within the meaning of in Directive (EU) 2018/1972 of the European Parliament and of the Council as defined in that Regulation.

Status : Valid
Language: English