GB 16174.1-2015 Active National standards force_standard

GB 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer

Publish Date: 2015-12-10 Implement Date: 2017-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 16174.1-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2015-12-10

Implement Date: 2017-07-01

Pages: 24 pages

Development Information

Word Count: 44 Thousand words Pages: 24 pages

Same series standard

GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers

Superseded by the following standards

GB 16174.1-2024 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer

Referenced Standards

GB/T 2423.22-2002 Environmental testing for electric and electronic products—Part 2:Test methods Test N:Change of temperature GB/T 2423.43-2008 Environmental testing for electric and electronic products—Part 2:Test methods—Mounting of specimens for vibration, impact and similar dynamic tests GB 9706.25-2005 Medical electrical equipment—Part 2:Particular requirements for the safety of electrocardiographic monitoring equipment ISO 8601 ISO 11607 ISO 14155 ISO 15223 IEC 60068-2-14 IEC 60068-2-32 IEC 60068-2-47 IEC 60068-2-64 IEC 61000-4-2 IEC 60601-1 IEC 60601-1-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-2-27