ISO 10993 & Medical Devices

Medical Device Testing: Residual ETO & Safety Assessment

Ethylene oxide is a highly effective sterilant for medical devices, catheters, syringes, and surgical implants. However, residual ETO gas and its reaction products are toxic and mutagenic. Satvam Research quantifies residual traces through thermal extraction and headspace chromatography to ensure levels are well below permissible daily contact limits.

Standard Turnaround
4 - 6 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Medical Device Safety Testing

Satvam Research provides residual ethylene oxide (ETO) testing and biocompatibility chemical characterization for sterilized medical devices and packaging. Utilizing Shimadzu headspace gas chromatography conforming to ISO 10993-7, we determine residual ETO and Ethylene Chlorohydrin (ECH) to guarantee patient safety prior to commercial distribution.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Exhaustive extraction and simulated-use extraction of sterilized medical devices
Quantitation of Residual Ethylene Oxide (ETO)
Quantitation of Ethylene Chlorohydrin (ECH)
Quantitation of Ethylene Glycol (EG)
Bioburden testing and packaging integrity verification
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

Headspace Gas Chromatography - Nexis GC-2050 with Headspace Sampler
Shimadzu Corporation
Model: Nexis GC-2050 with Headspace Sampler

Headspace Gas Chromatography

Exhaustive and simulated-use extraction of volatile ethylene oxide and chlorohydrins.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

ISO 10993-7 Biological Evaluation of Medical Devices – Ethylene Oxide Sterilization Residuals
ISO 10993-18 Chemical Characterization of Medical Device Materials
CDSCO Medical Devices Rules, 2017
USFDA Guidance on Ethylene Oxide Residuals
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
3 to 5 individually packaged sterilized medical devices from the same sterilization lot.
Container Type
Original sterile blister packaging or Tyvek pouches.
Storage Condition
Stored at ambient conditions; do not puncture or expose packaging prior to testing.
Standard TAT
4 - 6 business days
Special Instruction: State sterilization date and aeration cycle duration.
Frequently Asked Questions

Technical & Regulatory Inquiries

What is the allowable residual ETO limit under ISO 10993-7?

Limits depend on the category of device contact: limited exposure (≤ 24 hours: 4 mg ETO), prolonged exposure (1-30 days: 60 mg ETO), or permanent contact (> 30 days: 2.5 g lifetime limit).

Initiate Your Medical Device Safety Testing Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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