Independently tested. Fully documented.
XLube has been evaluated under the ISO 10993 biological evaluation framework for medical devices — the standard applied to products that contact human tissue. All test reports are from accredited third-party laboratories.
ISO 10993-5 Cytotoxicity
ISO 10993-23 Skin irritation
ISO 10993-23 Vaginal mucosa
ISO 10993-11 Systemic toxicity
Ph. Eur. 10 / USP <61><62>
1,4-Dioxane tested
1,4-Dioxane — not detected
XLube's polyethylene oxide raw material has been independently tested for 1,4-Dioxane — a trace contaminant that can occur in PEO-based products and is regulated by the FDA and EU. Result: not detected (n.d.) at a report limit of 5 mg/kg — below the FDA guidance threshold of 10 mg/kg.
Tissue viability
Results well above threshold
Skin (ISO 10993-23)
Non-irritant
Report 7015418-01-V1
Vaginal mucosa (ISO 10993-23)
Non-irritant
Report 7015418-02-V1
Cytotoxicity direct contact (ISO 10993-5)
Non-cytotoxic
Report 7015418-04-V1
Cytotoxicity filter diffusion (ISO 10993-5)
Non-reactive
Report 7015418-03-V1 + CN0006381.R
Biocompatibility
| Test | Standard | Result | Laboratory / Report |
|---|---|---|---|
| In vitro skin irritation | EN ISO 10993-23:2021 | Non-irritant Viability 102.9% | SGS Institut Fresenius 7015418-01-V1 · Jul. 2024 |
| In vitro vaginal mucosal irritation | EN ISO 10993-23:2021 | Non-irritant Viability 107.1% | SGS Institut Fresenius 7015418-02-V1 · Aug. 2024 |
| In vitro cytotoxicity — filter diffusion | ISO 10993-5:2009 | Grade 0 — no reactivity | SGS Institut Fresenius 7015418-03-V1 · Okt. 2024 |
| In vitro cytotoxicity — direct contact | ISO 10993-5:2009 | Non-cytotoxic Viability 110.6% | SGS Institut Fresenius 7015418-04-V1 · Nov. 2024 |
| Cytotoxicity — filter diffusion, cGMP/GLP | ISO 10993-5 / USP <87> | Grade 0 — no reactivity | Wickham Laboratories CN0006381.R · Aug. 2012 |
| Acute systemic toxicity | ISO 10993-11 | Confirmed | Global Regulatory Services GRS-Certificate · 2023 |
| Biological evaluation framework | BS EN ISO 10993-1:2020 | Confirmed | Global Regulatory Services GRS-Certificate · 2023 |
| 1,4-Dioxane (raw PEO) | Headspace-GC-MS | Not detected Report limit 5 mg/kg | SGS Institut Fresenius 6634996-01 · Jul. 2023 |
Microbiology
Ph. Eur. 10 / USP <61> <62>
| Parameter | Specification | Result |
|---|---|---|
| TAMC — Total aerobic microbial count | ≤ 1000 cfu/g | < 10 cfu/g |
| TYMC — Total yeast and mould count | ≤ 100 cfu/g | < 10 cfu/g |
| Staphylococcus aureus | n.d. in 1 g | Not detected |
| Pseudomonas aeruginosa | n.d. in 1 g | Not detected |
| Candida albicans | n.d. in 1 g | Not detected |
Testing Laboratories
SGS Institut Fresenius GmbH
Taunusstein, Germany
- DAkkS
- D-PL-14115-02-02
- D-PL-14115-17-00
Wickham Laboratories Ltd
Hampshire, United Kingdom
- MHRA & FDA registered
- GLP
- FEI 3002808506
Global Regulatory Services
Cambridge, United Kingdom
- Independent regulatory consultancy
- ISO 10993-1 Review
Documents
Download
Full compliance specification
PDF · All standards, reports, laboratory accreditations