T/CAMDI 176-2026 Pending Group standards

T/CAMDI 176-2026 Test Methods for the Evaluation of Shelf Life of Implantable Neurostimulators

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 176-2026

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

本文件规定了有源植入式神经刺激器货架寿命评价试验方法，包括货架有效期试验和包装运输测试阶段。本文件适用于有源植入式神经刺激器

Development Information

Drafting Units:

上海市医疗器械检验研究院、景昱医疗科技（苏州）股份有限公司、上海微创神奕医疗科技有限公司、杭州诺为医疗技术有限公司

Drafting Persons:

朱为然、贺飞、张奕、曹鹏、兰彦宇、邓伟

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