Validation of sterilization processes & sterile barrier systems ISO13485 § 7.5.7 Executive Series 64

Описание к видео Validation of sterilization processes & sterile barrier systems ISO13485 § 7.5.7 Executive Series 64

Links
• ISO 13485:2016: https://www.iso.org/standard/59752.html

• ISO 13485:2016 § 7.5.7: https://13485store.com/iso-13485-requ...

• Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download
o Chapter 3: Task 7
o Chapter 6: Task 9

• How to manage the medical device sterilization process according to ISO 13485:2016, By Waqas Imam, https://advisera.com/13485academy/blo...

Our requirement, Particular requirements for validation of processes for sterilization and sterile barrier systems, comes directly ISO 13485 § 7.5.7. There is no direct section in 820. In 820 this requirement links to 820.70, 820.75, & 820.130.

Particular requirements for validation of processes for sterilization and sterile barrier systems in 5 words: Ensure Sterile Devices are Sterile

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