Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
Edition 2022-07-01

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
Edition 2022-07-01

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
Edition 2023-10-04

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
Edition 2018-01-24

Ergonomics of the thermal environment - Medical supervision of individuals exposed to extreme hot or cold environments. (ISO 12894:2001)
Edition 2002-02-28

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
Edition 2015-12-16

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
Edition 2018-07-25

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition 2022-09-21

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Edition 2021-09-22

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) (Endorsed by Asociación Española de Normalización in September of 2021.)
Edition 2021-09-01