GB 16174.1-1996
Cardiac pacemakers--Part 1: Implantable pacemakers (English Version)
- Standard No.
- GB 16174.1-1996
- Language
- Chinese, Available in English version
- Release Date
- 1996
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2017-07
- Replace By
- GB 16174.2-2015
- GB 16174.1-2015
- Latest
- GB 16174.2-2015
- GB 16174.1-2015
- Scope
- This standard establishes basic terms and definitions, and specifies the marking and packaging requirements for implantable cardiac pacemakers. It also stipulates the minimum requirements and corresponding test methods for the ability of the pacemaker pulse generator to resist environmental stress. Appendix A explains the codes that differentiate the modes of operation of the pulse generator. Appendix B proposes the test method to confirm that the basic electrical parameters meet the requirements. Appendix C describes the estimation and expression of the nominal service life of the pulse generator. Appendix D provides an example of a technical information card. Appendix E is a rationale for certain clauses of this standard. Appendix F is an optional symbol that can replace written words. This standard applies to all fully implantable cardiac pacemakers, but does not cover the anti-tachyarrhythmia and defibrillation functions of pacemakers, nor does it cover isotope battery-driven pacemakers (nuclear pacemakers).
GB 16174.1-1996 history
- 2015 GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers
- 1996 GB 16174.1-1996 Cardiac pacemakers--Part 1: Implantable pacemakers
GB 16174.1-1996 Cardiac pacemakers--Part 1: Implantable pacemakers was changed to GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers.
