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Database: 365,228(8 Aug 2026)

In vitro diagnostic equipment

In vitro diagnostic equipment, Total:17 items.

The international standard classification for "In vitro diagnostic equipment" includes: Industrial process measurement and control .

The Chinese standard classification for "In vitro diagnostic equipment" includes: Medical laboratory equipment , Industrial automation and control device in general .


未注明发布机构

  • CLSI EP22-P-2010 Guidance for manufacturers to present risk mitigation information to users of in vitro diagnostic devices

Group Standards of the People's Republic of China

  • T/CAMDI 125-2024 Reliability test methods for in vitro diagnostic (IVD) medical equipment

Professional Standard - Medicine

  • YY 0648-2008 Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment

Bureau of Indian Standards

  • IS 17713-2023 In-Vitro Diagnostic IVD Devices - Elisa Plate Reader
  • IS 17715-2023 In-Vitro Diagnostic IVD Device - Elisa Plate Washer
  • IS 17721-2024 In-Vitro Diagnostic (IVD) Devices-Electrolyte Analyzer
  • IS 17714-2023 In-Vitro Diagnostic IVD Devices - Automated Elisa Processor

GOST

  • GOST R ISO 18113-5-2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
  • GOST R ISO 18113-3-2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use

IX-EU/EC

  • COM(95)/C 172/02-1995 Proposal for a European Parliament and Council Directive on in Vitro Diagnostic Medical Devices
  • COM(96) 643 FINAL-1996 Amended Proposal for a European Parliament and Council Directive Amending the Directive Proposal on in Vitro Diagnostic Medical Devices

British Standards Institution (BSI)

  • BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

International Organization for Standardization (ISO)

  • ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

Ente Nazionale Italiano di Unificazione

  • UNI EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

German Institute for Standardization

  • DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use

Swedish Institute for Standards

  • SS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)