DIN EN ISO 21536 E : 2014
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014)
12-01-2013
National foreword<br>National Annex NA (informative) - Bibliography<br>Foreword to EN ISO 21536:2009<br>Foreword to EN ISO 21536:2009/A1:2014<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Intended performance<br>5 Design attributes<br>6 Materials<br>7 Design evaluation<br>8 Manufacture<br>9 Sterilization<br>10 Packaging<br>11 Information to be supplied by<br> the manufacturer<br>Annex A (informative) - Evaluation of range of<br> relative angular motion of components of fully<br> constrained total knee joint replacement implants<br>Annex ZA (informative) - Relationship between this<br> European Standard and the Essential Requirements<br> of EU Directive 93/42/EEC on medical devices
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