ГОСТ Р ИСО 14607—2017
Библиография
[11 ASTM D 3389-94. Standard test method for coated fabrics abrasion resistance
[2] ASTM F 703-96. Standard specification for implantable breast prostheses
[3]ASTM P 604-94. Standard classification for silicone elastomers used in medical applications
[4] ASTM D 412. Test method for rubber properties in tension
[5JISO 14971. Medical devices — Application of risk management to medical devices
[6] ISO 4287. Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and
surface texture parameters
[7]ISO/TR 14283. Implants for surgery — Fundamental principles
[81 ISO 16054, Implants for surgery — Minimum data sets for surgical implants
[9J CR 14060. Medical device traceability [CEN Report]
[10] MEDDEV 2.7.1. Guidelines on Medical Devices — Evaluation of Clinical Data: Aguide for manufacturers and notified
bodies. April 2003
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