グローバルRA許認可

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試験技術支援

Applications

Medical device (manufacturing, import) licensing test

Consignment tests for self-quality control of manufacturers and importers (EO gas residual test, sterility test, etc.)

Tests for overseas certifications (FDA, CE certification, etc.) and international standards (IEC)

Testing for expiration date setting, sterilization validation, packaging and cleanroom validation, etc.

Related standard

  • 1) IEC 60601-1:2005/A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • 2) IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • 3) IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  • 4) IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • 5) IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • 6) ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • 7) ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • 8) ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
  • 9) ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Understanding the relevant standards

• Electronic medical device

National Standards

의료기기의 전기 기계적… EN 60601-1
BS EN 60601-1 JIS T0601-1
UL 2601-1

International Standards

Particular IEC 60601-2-2
Collateral IEC 60601-1-2
Base IEC 60601-1

• Medical supplies/dental materials

According to ISO10993-1, medical devices that come into direct or indirect contact with the patient's body must first check whether ISO10993 is applied through the flowchart below.

※ Summary of a systematic approach to the biological evaluation of medical devices as part of the risk management process

ISO10993 Test items can be checked through the ISO10993-1 Annex A (informative) below for medical supplies/dental materials whose application of ISO10993 has been confirmed according to the flow chart.

Medical device categorization by Biological effect
Nature of body contact (see 5.2) Concact duration
(see5.3)
A-limited(≤24h)
B-prolongged(>24h to 30d)
C-permanent(>30d) 		Cytotoxicith Sensitization Irritation or intracutaneous reactivity Systemic toxicity(acute) Subchronic toxicity (Subacute toxicity) genotoxicity Implantation Haemocompatibility
Category Contact
Surface device Skin A X a X X
B X X X
C X X X
Mucosal membrane A X X X
B X X X
C X X X X X
Breached or compromised surface A X X X
B X X X
C X X X X X
External communication device Blood path, indirect A X X X X X
B X X X X X
C X X X X X X
Tissue/bone/denitin A X X X
B X X X X X X X
C X X X X X X X
Circulation blood A X X X X X
B X X X X X X X X
C X X X X X X X
Implant device Tissue/bone A X X X
B X X X X X X X
C X X X X X X X
blood A X X X X X X X
B X X X X X X X X
C X X X X X X X X
米国CERTは、電子医療機器、医療用品·歯科材料などの応用分野に関連し、顧客のニーズと法的要件を満たすことができる体系的な試験官との協業を通じて専門的な技術支援が可能だ。