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Equipment 820.70g & ISO 13485 § 6.3, 7.5.1. (Executive Series #37)
Sterilization Families ISO 13485 § 7.5.6 & 7.5.7 (Executive Series 96)
Servicing 820.200 & ISO 13485 § 7.5.4, 8.4 (Executive Series #52)
Contamination 820.70e & ISO 13485 § 6.4.2, 7.5.2. (Executive Series #35)
Medical Device Sterilization Validation ISO § 7.5.6, 7.5.7, & 820.75 (Executive Series #81)
Validation of sterilization processes & sterile barrier systems ISO13485 § 7.5.7 Executive Series 64
Device History Record 820.184 & ISO 13485 § 7.5.1 (Executive Series #25)
Traceability 820.65 & ISO 13485 § 7.4.2 & 7.5.9 (Executive Series #30)
Inspection Measuring Test Equipment 820.72 & ISO 13485 § 7.6 (Executive Series #40)
Production and Process Controls General 820.70a & ISO 13485 § 7.1 & 7.5.1 (Executive Series #31)
Sterilization Revalidation – ISO § 7.5.6 and 7.5.7 (Executive Series #95)
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Last Updated: October 3, 2026
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