DZ/T 0101.12-1994
Active
GB/T 16886.6-2022
Active
National standards
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
Price:
$ 93
Basic Information
Standard Code:
GB/T 16886.6-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2022-04-15
Implement Date:
2023-05-01
Pages:
28 pages
Scope
This document specifies the test methods for evaluating the local reaction of biomaterials used in medical devices after implantation. This document is applicable to the following materials: -- solid and non-solid materials, such as porous materials, liquids, gels, pastes, and particulate materials, -- non-absorbable materials, and -- degradable and/or absorbable solid or non-solid materials. This document is also applicable to evaluating the local tissue reaction of medical devices that are expected to be used clinically on the surface of local injuries or the inner surface of injuries.
Development Information
Same series standard
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
Replace the following standards
Referenced Standards
ISO 10993-1
ISO 10993-2
ISO 10993-4
ISO 10993-12
ISO 10993-16
Adopt standards
ISO 10993-6:2016
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