ISO 29941:2010

Overview

ISO 29941:2010 - Condoms: Determination of nitrosamines migrating from natural rubber latex condoms defines an analytical test method to measure the release of N‑nitrosamines from condoms made from natural rubber latex. The standard describes sample preparation, migration/extraction, concentration and instrumental analysis using gas chromatography (GC) with a chemiluminescence detector (e.g., Thermal Energy Analyzer, TEA). Although written for latex male condoms, the method can also be applied to other barrier products (probe covers, female condoms, prophylactic dams) and synthetic-condom materials.

Key topics and technical requirements

• Scope and safety: Specifies migration testing for N‑nitrosamines; includes warnings about toxicity and light sensitivity (protect solutions from UV/fluorescent light; store <5 °C, wrapped in foil).
• Sample preparation: Uses condoms that conform to ISO 4074; cut and prepare test aliquots (typical test mass ~5 g) and perform aqueous migration at controlled temperature (40 ± 2 °C).
• Extraction/isolation: Two validated approaches:
  • Solid-phase type column extraction with diatomaceous earth (procedure A), or
  • Liquid‑liquid extraction using dichloromethane in a separatory funnel (procedure B).
• Concentration: Organic extracts are concentrated (solvent exchange to n‑hexane, Kuderna‑Danish concentration and gentle nitrogen blowdown) under controlled temperature to minimize loss of volatile N‑nitrosamines.
• Instrumental analysis: GC coupled to a chemiluminescence detector (TEA) after pyrolysis is specified to quantify target N‑nitrosamines by comparison with an internal standard (N‑nitrosodiisopropylamine, NDiPA).
• Target analytes: Includes common nitrosamines relevant to rubber vulcanization: NDMA, NDEA, NDBA, and where indicated, larger alkyl or aromatic nitrosamines (e.g., NDBzA, NDiNA).
• Quality & reporting: Requires use of analytical grade reagents, validated columns/detectors, and documented calculation/evaluation of results (ng/g).

Practical applications

• Routine quality control and batch release testing by condom manufacturers.
• Regulatory compliance testing by public health agencies and product safety labs.
• Contract testing laboratories seeking to implement validated methods for nitrosamines monitoring in barrier contraceptives and related medical devices.
• Research studies on migration of chemical residues from elastomeric products.

Who should use this standard

• Condom and medical device manufacturers
• Analytical and contract testing laboratories (ISO/IEC 17025 accredited)
• Regulatory bodies, toxicologists and product safety assessors
• Suppliers of latex processing chemicals and vulcanization accelerators

Related standards

• ISO 4074 - Natural rubber latex condoms - Requirements and test methods
• ISO 3696 - Water for analytical laboratory use
• ISO/IEC 17025 - Competence of testing and calibration laboratories

Keywords: ISO 29941:2010, nitrosamines in condoms, N‑nitrosamines testing, natural rubber latex, GC‑TEA, migration test, condom testing, analytical method.