Cleaning/ Disinfection process validation

Cleaning/ Disinfection process validation

“Reusable medical device ” is reprocessing procedures that follow specific instruction procedures, including cleaning, disinfection, and sterilization procedures. Device manufacturers manatory to specify reprocessing procedures in the Instruction for use manual and submit a validation report to the review agency.

Leon Biotech Co., Ltd has many experience of planning the “Reusable Medical Device ” reporessing validation plan and submit US FDA/ EU notified body review and accepted, and follow the US FDA guidelines,we can provide planning and implementation of reusable use product validation study.

  • “Reused Medical Device Products” Validation Plan Planning Consultation
  • Test Soil design for clinical specific situations
  • Reuse validation plan design for initial sterile products
  • Non-sterile product re-use validation program planning
  • Homecare medical device -Reuse validation verification plan for
  • Reuse validation program execution and report writing

服務內容

 

1. ISO 10993及中國GB/T 16886 生物相容性試驗方案規劃

ISO 10993-1 生物相容性試驗風險評估/項目規劃
ISO 10993-3 基因毒性試驗(沙門氏菌回復突變試驗/體外哺乳動物細胞基因突變試驗/體外哺乳類染色體結構畸變試驗/囓齒類週邊血液微核試驗)
ISO 10993-4  血液相容性試驗(溶血試驗/血栓試驗/補體啟動試驗/血小板黏附試驗/凝血試驗)
ISO 10993-5 體外細胞毒性試驗
ISO 10993-6 肌肉植入試驗
ISO 10993-6 皮下植入試驗
ISO 10993-6 骨植入試驗
ISO 10993-10 大白兔皮膚/皮內刺激性試驗
ISO 10993-10 天竺鼠皮膚致敏性試驗
ISO 10993-11 急性全身毒性試驗/亞急性全身毒性試驗/亞慢性全身毒性試驗/慢性全身毒性試驗
ISO 10993-11 大白兔熱原試驗
ISO 10993-17 & ISO 10993-18 材料化學特性分析與毒理風險評估
萃取Extractable/溶出 Leachable 試驗評估
ICP/MS、LC/MS、GC/MS、FTIR等分析方法開發
毒理風險評估計算(NOAEL、LOAEL & MOS)

2. 醫療器械大動物功效性試驗(比格犬、迷你豬、羊、猴子)

3. 重複用醫療器械清潔確效及消毒驗證

4. ISO 18562 呼吸器產品測試方案規劃

生物相容性測試項目

・體外細胞毒性試驗
・致敏試驗
・皮膚刺激試驗
・皮內刺激試驗
・急性全身毒性試驗
・亞急性全身毒性試驗
・亞慢性全身毒性試驗
・慢性全身毒性試驗
・熱原試驗
・染色體畸變試驗
・骨髓微核試驗

・凝血試驗
・血小板粘附試驗
・補體激活試驗
・溶血試驗
・肌肉植入試驗
・皮下植入試驗
・骨植入試驗
・鼠傷寒沙門氏菌
・恢復突變試驗
・基因突變試驗
・血栓形成試驗