What is BS EN 1811 – Nickel release test for jewellery and human body piercings about?
Adverse skin reaction to nickel has been known for many decades. Nickel is the most frequent cause of contact allergy in Europe, and 10 % to 20 % of the patch tested female population and 1 % to 3 % of the patch tested male population are allergic to nickel.
BS EN 1811 specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with No. 27 Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH).
Who is BS EN 1811 - Nickel release test for jewellery and human body piercings for?
BS EN 1811 guidelines on nickel release test are useful for:
- Jewellery manufacturers
- Ear stud or body piercing product manufacturers
- Quality control and testing laboratories
- Health and safety authorities
- Regulatory bodies
Why should you use BS EN 1811 - Nickel release test for jewellery and human body piercings?
Skin absorption of nickel ions, which are released from some nickel-containing materials which are inserted into pierced ears or other pierced parts of the human body or which are in direct and prolonged contact with the skin, causes sensitisation. Further exposure to soluble nickel salts results in allergic contact dermatitis.
It is known that sensitisation to nickel requires higher exposure levels than does the elicitation in already sensitised individuals. There is a large variation in the degree of sensitivity to nickel between individuals. This widespread health problem has forced the introduction of a number of measures designed to reduce its prevalence. These measures include the requirements of BS EN 1811 which provides an in-vitro chemical test that correlates as far as possible with the variable human biological reactions that occur when metallic particles containing nickel are in direct and prolonged contact with the skin and pierced parts of the body. BS EN 1811 provides a measure of the amount of nickel release from an article immersed for one week in artificial sweat. The standard also describes the preparation of a quality control material intended to assist a laboratory in achieving an acceptable precision. Clinical patch-testing of a small selection of nickel-containing alloys and coatings on nickel-sensitized persons indicates that high and low results achieved with the present analytical method correspond closely with patch-test reactivity as mentioned in BS EN 1811.
