GB 12264-1990
Replaced
GB 16174.2-2015
Active
National standards
force_standard
GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers
GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers
Basic Information
Standard Code:
GB 16174.2-2015
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2015-12-10
Implement Date:
2017-07-01
Pages:
86 pages
Scope
This part of GB 16174 specifies the requirements for active implantable medical devices [HTH] used in the treatment of chronic arrhythmia.
The tests specified in this part are type tests, and the conformity is confirmed through the testing of samples.
This part also applies to certain non-implantable parts and accessories of the device.
Development Information
Same series standard
Replace the following standards
Superseded by the following standards
Referenced Standards
ISO 5841-3
ISO 8601
ISO 11318
ISO 14708-1
IEC 60068-2-27
IEC 60068-2-47
IEC 60068-2-64
ANSI/AAMI PC69
Adopt standards
ISO 14708-2:2005
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced