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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

Medical laboratories - Requirements for quality and competence

Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes

Laboratory glassware - Petri dishes (ISO 13132:2023) (Endorsed by Asociación Española de Normalización in June of 2023.)

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Basic semen examination - Specification and test methods (ISO 23162:2021)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

Medical laboratories — Requirements for safety

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (Endorsed by Asociación Española de Normalización in October of 2020.)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Quality management systems - EN ISO 9001:2015 for healthcare

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by AENOR in November of 2015.)