Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

AAMI ISO 27186 : 2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
Available format(s)

Hardcopy , PDF

Withdrawn date

07-28-2023

Language(s)

English

Published date

01-01-2010

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 27186:2010
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

Describes a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions.

DocumentType
Standard
ISBN
157020380-6
Pages
99
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Withdrawn

Standards Relationship
ISO 27186:2010 Identical

AAMI PC69 : 2007
ASTM B 348 : 2013 : REDLINE Standard Specification for Titanium and Titanium Alloy Bars and Billets
ISO 7436:1983 Slotted set screws with cup point
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
ISO 11318:2002 Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)

View more information
US$290.00
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English - DRM
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us