ISO 14602:2010
Non-active surgical implants - Implants for osteosynthesis - Particular requirements
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.
In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
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- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.
The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.
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