M00028715
New product
ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
International Organization for Standardization
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Availability date: 11/05/2021
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (normative) - Electrical isolation test
Annex B (informative) - Rationale for Annex A
Annex C (normative) - Dielectric strength test
Annex D (informative) - Rationale for Annex C
Annex E (normative) - Current-carrying test high voltage
types
Annex F (informative) - Rationale for Annex E
Annex G (informative) - Lead connector fatigue strength test
Annex H (informative) - Lead connector seal zone materials
Annex I (informative) - Seal zone creep
Annex J (informative) - Contact resistance stability
Annex K (informative) - Rationale for Annex J
Annex L (informative) - Selection of contact materials
Annex M (normative) - Lead connector contact material
requirements
Annex N (informative) - Rationale for Annex M
Annex O (informative) - Rationale for requirements in this
International Standard
Annex P (informative) - Connector products (e.g. adaptors,
extenders, patient cables, etc.)
Bibliography
This International Standard specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 150 |
Supersedes |
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