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Pre-standard

ISO/TS 11633-1

Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1: Requirements and risk analysis
Edition 2019-08

Technical rule [CURRENT]

ISO/TR 80001-2-7

Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
Edition 2015-04

Technical rule [CURRENT]

ISO/TR 21730

Health informatics - Use of mobile wireless communication and computing technology in healthcare facilities - Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
Edition 2007-02

Effizient DIN EN 62366-1- und FDA-konform dokumentieren
Edition 2020-12

Standards [CURRENT]

DIN 58921

Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
Edition 2011-01

Standards [CURRENT]

DIN 13273-8

Catheters for medical use - Part 8: Epidural catheters
Edition 2020-07

Standards [CURRENT]

DIN EN ISO 8536-8

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015); German version EN ISO 8536-8:2015
Edition 2015-11

Standards [CURRENT]

DIN EN ISO 15882

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); German version EN ISO 15882:2008
Edition 2008-12

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

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