T/CAMDI 175-2026 Pending Group standards

T/CAMDI 175-2026 Guidelines for the Evaluation Format of the Service Life of Active Medical Devices

Publish Date: 2026-01-15 Implement Date: 2026-07-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: T/CAMDI 175-2026

Standard Type: Group standards

Standard Status: Pending

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Integrated medical equipment

Publish Date: 2026-01-15

Implement Date: 2026-07-15

Technical Committee: 中国医疗器械行业协会

Scope

本文件规定了有源医疗器械预期使用期限评价文件的编制要求，涵盖预期使用期限评价的对象、路径规划、故障分析、评价方法及试验记录与报告等。本文件适用于有源非植入类医疗器械（医疗器械软件除外）和有源植入类医疗器械，为其预期使用期限评价提供标准化的技术框架与操作指引

Development Information

Drafting Units:

上海市医疗器械检验研究院、上海市医疗器械化妆品审评核查中心、航卫通用电气医疗系统有限公司、上海联影医疗科技股份有限公司、施爱德(厦门)医疗器材有限公司、哈尔滨思哲睿智能医疗设备股份有限公司

Drafting Persons:

兰彦宇、牛帅、张存礼、贾东方、胡林锋、朱国辉、卢卫卫、马克刚

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