PREN 1811 : DRAFT 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Reagents
4 Apparatus
5 Samples
  5.1 Sample area
      5.1.1 Definition of sample area
      5.1.2 Determination of sample area
      5.1.3 Areas other than sample areas
  5.2 Sample degreasing before testing
  5.3 Quality control samples
6 Procedure
  6.1 Principle of the procedure
  6.2 Preparation of test solution
  6.3 Release procedure
  6.4 Determination of nickel
      6.4.1 General
      6.4.2 Calibration solutions
      6.4.3 Detection limit
      6.4.4 Number of test samples
      6.4.5 Number of replicate measurements
  6.5 Blank tests
7 Calculations
  7.1 Nickel release
  7.2 Interpretation of results
      7.2.1 General
      7.2.2 Compliance assessment
      7.2.3 Uncertainty budget
8 Test report
Annex A (informative) - Measurement uncertainty of the
        test procedure and compliance assessment
Annex B (normative) - Requirements for quality control
        material
Annex C (normative) - A guide for preparation prior to nickel
        release testing for post assemblies which are inserted
        into pierced parts of the human body and products
        intended to come into direct and prolonged contact
        with the skin
  C.1 Introduction
  C.2 Terms and definitions for Annex C
  C.3 Requirements and principle
  C.4 Determination of the nickel release test method
  C.5 Determination of surfaces coming into direct
      and prolonged contact with the skin or pierced
      parts of the body
      C.5.1 General
      C.5.2 Jewellery products
      C.5.3 Spectacle frames and sunglasses
      C.5.4 Textiles, footwear, garments and leather goods
  C.6 Methods of determining the surface areas
      C.6.1 Surface area measurements
      C.6.2 Minimum surface area
      C.6.3 Simplification of surface area determination
            using common shapes of consumer products
  C.7 Testing apparatus prior to nickel release testing
Annex D (informative) - Articles made from composite materials
Bibliography

Defines 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 items are in compliance with the European Directive 76/769/EEC as amended by 94/27/EC and 2004/96/EC.