MENSTRUAL CUPS AND DISCS
Assessed materials. Documented quality.
From material to contact with the body: see the documentation for medical silicone, ISO 10993 biocompatibility, USP Class VI and the related tests. Each sheet identifies the sample, the method and the documented result.
See the certifications page for this categoryThe documentation, explained simply.
Select a logo or document. The data and results open here.
Open the sheet to see the document number, available data, results and the source consulted. Declared information is marked separately from data extracted from the originals.
MATERIAL · WACKER ELASTOSIL® · ISO 10993 · USP CLASS VIWhat does medical silicone mean?+
The documentation for the silicone includes biocompatibility assessments under ISO 10993 and USP Class VI. They concern the biological reaction to the material under the tested conditions.
Documentation for the raw material assessed under the standards mentioned.
LABORATORY TEST · Analysis report · RoHSSubstances analysed: the results of report HLF23006046E+
The report for the sample “Menstrual Cup”, model “sport cup”, records PASS for the substances analysed. The substances analysed were not detected at the measurement limits shown below.
- Report
- HLF23006046E
- Date
- 24.02.2025
- Sample
- Menstrual Cup · sport cup
- Reference in the report
- RoHS · (EU) 2015/863 / 2011/65/EU
| Substance | Result | Detection limit |
|---|---|---|
| Lead / cadmium / mercury | Not detected | 2 mg/kg each |
| Hexavalent chromium | Not detected | 8 mg/kg |
| DBP, BBP, DEHP, DIBP | Not detected | 0.005% each |
Results for the “sport cup” sample in report HLF23006046E.
Source consulted
RoHS report HLF23006046E, pp. 1–3 and 5.
TECHNICAL DOCUMENT · Safety data sheetSDS: material identification and declared classification+
The SDS identifies the sample as “Menstrual Cup/Disc” and records that the product is not classified as hazardous under CLP.
- Issuer
- Shenzhen Huipu Testing Technology Co., Ltd.
- Number
- HPT240011808MEA
- Date
- 23.01.2024
- Document type
- Safety Data Sheet · 8 pages
The SDS describes the identification and classification of the “Menstrual Cup/Disc” sample.
Source consulted
Safety data sheet HPT240011808MEA, pp. 1–3.
TECHNOLOGY · SANICONCENTRATE™ · PARX MATERIALSSaniconcentrate™: action within the material itself+
Saniconcentrate™ is Parx Materials’ technology built into the material to limit the adhesion of microorganisms and the formation of biofilm on the surface.
- Technology
- Saniconcentrate™ · Passive Action Polymer Technology™
- Developer
- Parx Materials
- Mechanism described
- Physical action on the adhesion of microorganisms to the material
- Integration
- Additive incorporated into the material during manufacturing
What does the official source document?
Parx Materials presents the use of the technology in materials for medical and hygiene applications. The dedicated page describes the assessment by Zwiers Regulatory Consultancy of safety data and biological evaluation results, with reference to ISO 10993.
This information describes the Saniconcentrate™ technology. Reports for Femieko products are presented separately, for the samples assessed.
Official source: Parx Materials ↗Parx Materials · Medical applications. The explanation can be read here; the link gives optional access to the original source.
