IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
€389.00
IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology
€57.00
Medical device software Part 2: Validation of software for medical device quality systems
€261.00
Application of risk management for IT-networks incorporating medical devices Part 2-6: Application guidance — Guidance for responsibility agreements
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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
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
€81.00
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
€130.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
€0.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)
€121.00
QUALITY SYSTEMS. MEDICAL DEVICES. PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003
€60.00
GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES.
€26.00
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
€53.00
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange. (ISO 15225:2000)
€69.00
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
€140.00
Symbols for use in the labelling of medical devices
