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BS EN 30993-6:1995 Biological evaluation of medical devices - Part 6. Tests for local effects after implantation

Other Titles Withdrawn Description Printed version of this is available at library. To request, please e-mail to referencepk@usm.my and include a copy of this record in your e-mail. Abstract This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and micro- scopic level. The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).

Contributor(s): MAR - Data Entry Person Primary Item Type: British Standard Identifiers: ICS 11.100.20 Biological evaluation of medical devices ISBN 0580235939 Language: English Subject Keywords: Goats; Tissue implantation tests; Rodentia; Rabbits; Sheep; Biological analysis and testing; Test specimens; Testing conditions; Surgical equipment; Dental materials; Pigs; Specimen preparation; Dogs; Dental prosthesis; Orthopaedic equipment; Implants (surgical); Biological hazards First presented to the public: 4/17/2023 Original Publication Date: 4/15/1995 Previously Published By: British Standards Institution Place Of Publication: London, United Kingdom Citation: Extents: Number of Pages - 18 License Grantor / Date Granted:   / ( View License ) Date Deposited 2023-04-17 10:25:17.889 Submitter: Muhamad Azmil Ramli

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