Non-active surgical implants - Mammary implants - Specific requirements (ISO/DIS 14607:2023); German and English version prEN ISO 14607:2023
Edition 2023-09

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024
Edition 2024-06

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
Edition 2024-07

Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
Edition 2023-03

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023
Edition 2023-04

Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German and English version prEN 13060:2023
Edition 2023-05

Natural rubber latex male condoms - Requirements and test methods (ISO/DIS 4074:2024); German and English version prEN ISO 4074:2024
Edition 2024-09

External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022); German and English version prEN ISO 22523:2022
Edition 2022-05

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Edition 2024-04

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
Edition 2021-12