NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 12417-1 [CURRENT] references following documents:

Document number Edition Title
ISO 16428 2005-04 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices More 
ISO 16429 2004-07 Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods More 
ISO 17475 2005-10 Corrosion of metals and alloys - Electrochemical test methods - Guidelines for conducting potentiostatic and potentiodynamic polarization measurements More 
ISO 25539-3 2011-12 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters More 
ISO 5841-2 2014-08 Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads More 
2001/83/EG 2001-11-06 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use More 
2004/10/EG 2004-02-11 Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances More 
2004/9/EG 2004-02-11 Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) More