GB/T 16886.4-2022 Active National standards

GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

Publish Date: 2022-04-15 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.4-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2022-04-15

Implement Date: 2023-05-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

Technical Committee: 全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)

Pages: 64 pages

Scope

本文件规定了医疗器械与血液相互作用评价的通用要求。
本文件给出了：
a)按照ISO 109931规定的预期用途和接触时间对接触血液的医疗器械进行分类；
b)器械与血液相互作用基本评价原则；
c)根据具体器械分类，结合试验基本原理和科学依据选择组合相应试验的原则。
由于受器械与血液相互作用方面的认识以及试验的精密度所限，不能规定详细的试验要求，因而本文件只是对生物学评价进行概括性的描述，未必能为具体器械提供足够的试验方法指南。
本文件的变化并不表明根据之前的版本进行试验是无效的。对具有安全临床使用史的上市器械，不推荐按照本次修订进行附加的试验。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、四川大学(四川医疗器械生物材料和制品检验中心)、广东省医疗器械质量监督检验所

Drafting Persons:

侯丽、乔春霞、袁暾、杨立峰、赵增琳、郑利萍、莫晓彦

Word Count: 123 Thousand words Pages: 64 pages

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 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation 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

GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood

Referenced Standards

ISO 10993-1 ISO 10993-12

Adopt standards

ISO 10993-4:2017

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24