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Standards [CURRENT]

UNE-EN ISO 16637

Radiological protection - Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources (ISO 16637:2016) (Endorsed by Asociación Española de Normalización in July of 2019.)
Edition 2019-07-01

Standards [CURRENT]

UNE-EN ISO 16645

Radiological protection - Medical electron accelerators - Requirements and recommendations for shielding design and evaluation (ISO 16645:2016) (Endorsed by Asociación Española de Normalización in July of 2019.)
Edition 2019-07-01

Standards [CURRENT]

UNE-EN ISO 17510

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
Edition 2021-04-07

Standards [CURRENT]

UNE-EN ISO 17511

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
Edition 2022-03-02

Standards [CURRENT]

UNE-EN ISO 17664-1

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Edition 2022-06-01

Standards [CURRENT]

UNE-EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
Edition 2007-06-27

Standards [CURRENT]

UNE-EN ISO 18082

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014)
Edition 2014-12-10

Standards [CURRENT]

UNE-EN ISO 18082/A1

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases - Amendment 1 (ISO 18082:2014/Amd 1:2017)
Edition 2018-05-16

Standards [CURRENT]

UNE-EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Edition 2012-02-22

Standards [CURRENT]

UNE-EN ISO 18113-2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
Edition 2012-02-22

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