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Standards [CURRENT]

PD ISO/PAS 18761

Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
Edition 2013-02-28

Standards [CURRENT]

AS/NZS IEC 60601.2.34

Medical electrical equipment, Part 2.34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Edition 2022

Standards [CURRENT]

ASTM F 2382

Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
Edition 2018

Standards [CURRENT]

UNE-EN ISO/IEEE 11073-10407

Health informatics - Device interoperability - Part 10407: Personal health device communication - Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2022) (Endorsed by Asociación Española de Normalización in February of 2023.)
Edition 2023-02-01

Standards [CURRENT]

UNE-EN ISO 1135-3

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
Edition 2017-11-02

Draft standard

24/30475247 DC

BS EN ISO 10993-4:2017/Amd 1 Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood. Amendment 1
Edition 2024-03-07

Standards [CURRENT]

UNE-EN ISO 23908

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
Edition 2013-04-03

Standards [CURRENT]

UNE-EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Edition 2018-01-24

Standards [CURRENT]

UNE-EN ISO 17099

Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014)
Edition 2018-04-11

Standards [CURRENT]

UNE-EN ISO 8637-1

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
Edition 2020-10-21

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