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Device Validation Guidelines

Device Validation Guidelines, Total:17 items.

In the international standard classification, Device Validation Guidelines involves: Protection against fire, Electrical engineering in general, Quality, Pharmaceutics.


British Standards Institution (BSI), Device Validation Guidelines

  • BS EN 60695-11-2:2004 Fire hazard testing - Test flames - 1 kW nominal pre-mixed flame - Apparatus, confirmatory test arrangement and guidance
  • BS EN 60695-11-2:2003 Fire hazard testing - Test flames - 1 kW nominal pre-mixed flame - Apparatus, confirmatory test arrangement and guidance
  • BS EN 60695-11-2:2014 Fire hazard testing. Test flames. 1 kW nominal pre-mixed flame: Apparatus, confirmatory test arrangement and guidanc
  • BS EN 60695-11-5:2005 Fire hazard testing - Test flames - Needle-flame test method - Apparatus, confirmatory test arrangement and guidance
  • PD ISO/TR 22696:2020 Health informatics. Guidance on the identification and authentication of connectable Personal Healthcare Devices (PHDs)
  • BS IEC 62481-7:2017 Digital living network alliance (DLNA) home networked device interoperability guidelines - Authentication

Professional Standard - Certification and Accreditation, Device Validation Guidelines

  • RB/T 160-2017 Guidance on verification and overall evaluation of analytical chemistry instrument

International Electrotechnical Commission (IEC), Device Validation Guidelines

  • IEC 60695-11-2:2013 Fire hazard testing - Part 11-2: Test flames - 1 kW pre-mixed flame - Apparatus, confirmatory test arrangement and guidance
  • IEC 60695-11-2:2003 Fire hazard testing - Part 11-2: Test flames; 1 kW nominal pre-mixed flame; Apparatus, confirmatory test arrangement and guidance
  • IEC 60695-11-2/COR1:2006 Fire hazard testing - Part 11-2: Test flames - 1 kW nominal pre-mixed flame - Apparatus, confirmatory test arrangement and guidance; Corrigendum 1

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Device Validation Guidelines

  • GB/Z 42344-2023 Guidelines for Validation of Pharmaceutical Machinery (Equipment) Computerized System

Japanese Industrial Standards Committee (JISC), Device Validation Guidelines

  • JIS C 60695-11-2:2007 Fire hazard testing -- Part 11-2: Test flames -- 1 kW nominal pre-mixed flame -- Apparatus, confirmatory test arrangement and guidance
  • JIS C 60695-11-2:2016 Fire hazard testing -- Part 11-2: Test flames -- 1 kW nominal pre-mixed flame -- Apparatus, confirmatory test arrangement and guidance

American Society for Testing and Materials (ASTM), Device Validation Guidelines

  • ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

German Institute for Standardization, Device Validation Guidelines

  • DIN EN 60695-11-2:2004 Fire hazard testing - Part 11-2: Test flames - 1 kW nominal pre-mixed flame - Apparatus, confirmatory test arrangement and guidance (IEC 60695-11-2:2003); German version EN 60695-11-2:2003

ES-UNE, Device Validation Guidelines

  • UNE-EN 60695-11-2:2018 Fire hazard testing - Part 11-2: Test flames - 1 kW nominal pre-mixed flame - Apparatus, confirmatory test arrangement and guidance




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