DIN EN ISO 4074 2017-09 PDF

Full title and description

STB DIN EN ISO 4074:2017-09 — Natural rubber latex male condoms — Requirements and test methods. This is the German adoption (DIN EN) of EN ISO 4074:2015 / ISO 4074:2015 and specifies the material, mechanical and performance requirements and the test methods used to verify safety, integrity and labelling of male condoms made from natural rubber latex.

Abstract

This document sets out mandatory requirements and standardized test methods for male condoms manufactured from natural rubber latex, covering physical properties (dimensions, tensile strength, burst volume/pressure), freedom from holes, packaging, labelling and storage/ageing requirements to ensure effective contraceptive and STI-barrier performance. It reflects the text of ISO 4074:2015 as adopted nationally in Germany.

General information

• Status: Published / current (national adoption of EN ISO 4074:2015).
• Publication date: September 2017 (DIN designation: 2017-09).
• Publisher: Deutsches Institut für Normung (DIN) — as DIN EN ISO adoption; original international publisher: ISO.
• ICS / categories: 11.200 (Birth control; mechanical contraceptives).
• Edition / version: DIN EN ISO 4074:2017-09 (German version of EN ISO 4074:2015 / ISO 4074:2015, Edition 3).
• Number of pages: 78 (DIN national publication pagination; ISO original edition lists 56 pages for ISO 4074:2015).

Scope

The standard applies to male condoms manufactured from essentially natural rubber latex. It defines the essential characteristics required to help ensure effectiveness as a contraceptive and as a barrier against STIs: dimensional requirements and tolerances, material and biocompatibility considerations, mechanical strength and elasticity, acceptable defect rates (freedom from holes), sampling and testing procedures (water leak tests, burst/elongation tests, tensile tests), packaging integrity, labelling content and storage/ageing conditions. It is intended for use where natural rubber latex is the primary material; alternative materials are covered by separate standards.

Key topics and requirements

• Material definition: requirements for natural rubber latex and limits on additives/impurities.
• Physical dimensions and tolerances (length, nominal width, wall thickness) for proper fit and function.
• Freedom from holes: defined sampling and water-leak test procedures to verify absence of holes.
• Mechanical performance: burst volume and burst pressure, tensile strength and elongation criteria.
• Ageing and storage: accelerated ageing tests and storage/expiry labeling to preserve safety over shelf life.
• Packaging and labelling: packaging integrity tests and mandatory label information to ensure safe use and traceability.
• Sampling, inspection and conformity: prescribed sampling plans and acceptance criteria for production lots.

These topics and the specific test methods are described in detail in the standard text (ISO 4074:2015 / DIN EN ISO 4074:2017-09).

Typical use and users

Primary users include condom manufacturers (product design, production and quality control), independent testing laboratories, national standards bodies and regulators, procurement officers for public health programs, and conformity assessment bodies. The standard is used to define production specifications, sampling and test protocols, and to underpin regulatory compliance and quality assurance for latex male condoms.

Related standards

Closely related and complementary documents include ISO 4074:2015 (the source international standard), ISO 23409 (requirements for condoms made from synthetic materials), ISO 16038:2017 (guidance on use of ISO 4074 and ISO 23409 in quality management), and the EN/adopted national variants (e.g., EN ISO 4074 and various national adoptions such as DIN EN ISO 4074). Regulatory and medical-device guidance documents may reference these standards for conformity assessment.

Keywords

Condoms, natural rubber latex, male condom, ISO 4074, DIN EN ISO 4074, requirements, test methods, burst pressure, water-leak test, tensile strength, packaging, labelling, ICS 11.200.

FAQ

Q: What is this standard?

A: STB DIN EN ISO 4074:2017-09 is the German adoption of EN ISO 4074:2015 / ISO 4074:2015, titled "Natural rubber latex male condoms — Requirements and test methods", which specifies mandatory performance and testing requirements for latex male condoms.

Q: What does it cover?

A: It covers material definitions, dimensional requirements, mechanical performance (burst, tensile, elongation), freedom from holes (leak tests), packaging and labelling, sampling and conformity assessment, and ageing/storage requirements for condoms made from natural rubber latex.

Q: Who typically uses it?

A: Manufacturers, quality/control laboratories, conformity assessment bodies, regulators and public-health procurement agencies use the standard to specify product requirements, run tests, and demonstrate compliance.

Q: Is it current or superseded?

A: The DIN EN ISO 4074:2017-09 publication is the national adoption of ISO 4074:2015 and replaced earlier national/older versions; ISO 4074:2015 is the relevant international edition. Users should check national standards bodies for any later amendments or revisions after 2017.

Q: Is it part of a series?

A: Yes — ISO 4074 consolidates previous parts into a single document for natural rubber latex condoms. It sits alongside related documents such as ISO 23409 (synthetic-material condoms) and ISO 16038 (quality-management guidance for condoms).

Q: What are the key keywords?

A: Natural rubber latex, male condom, test methods, burst pressure, water-leak test, tensile strength, packaging, labelling, ISO 4074, DIN EN ISO 4074.