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Technical Specification

DIN/TS 5343

Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods; Text in German and English
Edition 2022-04

Standards [CURRENT]

DIN 58953-8

Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
Edition 2019-03

Standards [CURRENT]

DIN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024
Edition 2024-09

Standards [CURRENT]

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024
Edition 2025-01

Standards [CURRENT]

DIN EN 15986

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
Edition 2011-05

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (IEC 80001-1:2021); German version EN IEC 80001-1:2021
Edition 2023-02

Draft standard

DIN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024); German and English version prEN ISO 7405:2024
Edition 2024-04

Standards [CURRENT]

DIN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018
Edition 2019-03

Standards [CURRENT]

DIN EN ISO 9626

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016
Edition 2016-12

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