Standard No.:	YY/T 0491-2004
English Name:	Cardiac pacemakers—Low-profile connectors(IS-1) for implantable pacemakers
Chinese Name:	心脏起搏器植入式心脏起搏器用的小截面连接器
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	SDA
Issued on:	2004-10-10
Implemented on:	2005-9-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	4000 words
Price(USD):	100.0
Delivery:	via email in 1 business day

1 Scope This standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods. Other connector features such as fastening means and materials are not specified in this standard. This standard is applicable only to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance or reliability of different leads and pulse generator assemblies. The connector cavity specified in this part is not applicable if the implantable pulse generator is capable of introducing dangerous nonpacing signals (e.g. defibrillation signals) through an IS-1 connector (see 4.3.3). This standard supplements GB 16174.1 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirements in GB 16174.1. Note: Pacemaker connector assemblies not complying with this standard may be safe and reliable and may have clinical advantages.

Contents 1 Scope 2 Normative References 3 Terms and definitions 4 Requirements Appendix A (Normative) Lead Connector Electrical Impedance Test Method Appendix B (Informative) Rationale